carbamates has been researched along with Colorectal Neoplasms in 47 studies
Colorectal Neoplasms: Tumors or cancer of the COLON or the RECTUM or both. Risk factors for colorectal cancer include chronic ULCERATIVE COLITIS; FAMILIAL POLYPOSIS COLI; exposure to ASBESTOS; and irradiation of the CERVIX UTERI.
| Excerpt | Relevance | Reference |
|---|---|---|
| "Encorafenib plus cetuximab with or without binimetinib showed increased objective response rate (ORR), progression-free survival (PFS), and overall survival (OS) compared with chemotherapy plus anti-EGFR in previously treated patients with BRAF V600E-mutated (mut) metastatic colorectal cancer (mCRC)." | 9.51 | Encorafenib plus cetuximab with or without binimetinib in patients with BRAF V600E-mutated metastatic colorectal cancer: real-life data from an Italian multicenter experience. ( Antista, M; Antonuzzo, L; Bensi, M; Boccaccino, A; Borelli, B; Cremolini, C; Crespi, V; Giampieri, R; Giordano, M; Intini, R; Libertini, M; Lonardi, S; Moretto, R; Noto, C; Noto, L; Parisi, A; Passardi, A; Persano, M; Puccini, A; Rihawi, K; Rossini, D; Roviello, G; Salati, M; Tamberi, S; Zichi, C, 2022) |
| "Recently, the introduction of encorafenib in combination with cetuximab was considered as a practice changing in BRAFV600-mutated metastatic colorectal cancer." | 8.12 | Cost-effectiveness of encorafenib plus cetuximab in BRAF V600E-mutated colorectal cancer. ( Bonetti, A; Giuliani, J; Mantoan, B, 2022) |
| "Two new treatments have recently become standard care for patients with metastatic colorectal cancer (mCRC): encorafenib (BRAF inhibitor) associated with cetuximab (anti-EGFR) in the second or third line of chemotherapy for BRAF V600E tumors, and pembrolizumab (an anti PD-1 immune checkpoint inhibitor) for tumors harboring microsatellite instability (MSI)-high and/or deficient mismatch repair (dMMR)." | 8.12 | Upfront progression under pembrolizumab followed by a complete response after encorafenib and cetuximab treatment in BRAF V600E-mutated and microsatellite unstable metastatic colorectal cancer patient: A case report. ( Broudin, C; Gallois, C; Garinet, S; Karoui, M; Sabouret, A; Taieb, J; Zaanan, A, 2022) |
| "Recently the phase 3 BEACON trial showed that the combination of encorafenib, cetuximab, and binimetinib versus cetuximab and irinotecan/FOLFIRI improved overall survival in pre-treated patients with metastatic colorectal cancer (mCRC) with BRAF V600E mutation." | 8.02 | Cost-Effectiveness Analysis of Encorafenib, Binimetinib, and Cetuximab in BRAF V600E-Mutated Metastatic Colorectal Cancer in the USA. ( Ding, D; Hu, H; Huang, J; Li, S; Zhu, Y, 2021) |
| " We have evaluated several commercially available benzimidazole carbamates for cytotoxic activity in colorectal cancer cells." | 7.81 | ERK-dependent phosphorylation of HSF1 mediates chemotherapeutic resistance to benzimidazole carbamates in colorectal cancer cells. ( Higa, AT; Jacobs, AT; McAllister, HA; Taylor, FR; Wales, CT, 2015) |
| " Adverse event (AE) profiles of specific BRAF inhibitors vary, however, and are affected by the specific agents given in combination." | 6.72 | Management of adverse events from the treatment of encorafenib plus cetuximab for patients with BRAF V600E-mutant metastatic colorectal cancer: insights from the BEACON CRC study. ( Christy-Bittel, J; Ciardiello, F; Desai, J; Gollerkeri, A; Grothey, A; Kopetz, S; Maharry, K; Tabernero, J; Trevino, TL; Van Cutsem, E; Velez, L; Wasan, H; Yaeger, R; Yoshino, T, 2021) |
| "Encorafenib plus cetuximab with or without binimetinib showed increased objective response rate (ORR), progression-free survival (PFS), and overall survival (OS) compared with chemotherapy plus anti-EGFR in previously treated patients with BRAF V600E-mutated (mut) metastatic colorectal cancer (mCRC)." | 5.51 | Encorafenib plus cetuximab with or without binimetinib in patients with BRAF V600E-mutated metastatic colorectal cancer: real-life data from an Italian multicenter experience. ( Antista, M; Antonuzzo, L; Bensi, M; Boccaccino, A; Borelli, B; Cremolini, C; Crespi, V; Giampieri, R; Giordano, M; Intini, R; Libertini, M; Lonardi, S; Moretto, R; Noto, C; Noto, L; Parisi, A; Passardi, A; Persano, M; Puccini, A; Rihawi, K; Rossini, D; Roviello, G; Salati, M; Tamberi, S; Zichi, C, 2022) |
| "Recently, the introduction of encorafenib in combination with cetuximab was considered as a practice changing in BRAFV600-mutated metastatic colorectal cancer." | 4.12 | Cost-effectiveness of encorafenib plus cetuximab in BRAF V600E-mutated colorectal cancer. ( Bonetti, A; Giuliani, J; Mantoan, B, 2022) |
| "Two new treatments have recently become standard care for patients with metastatic colorectal cancer (mCRC): encorafenib (BRAF inhibitor) associated with cetuximab (anti-EGFR) in the second or third line of chemotherapy for BRAF V600E tumors, and pembrolizumab (an anti PD-1 immune checkpoint inhibitor) for tumors harboring microsatellite instability (MSI)-high and/or deficient mismatch repair (dMMR)." | 4.12 | Upfront progression under pembrolizumab followed by a complete response after encorafenib and cetuximab treatment in BRAF V600E-mutated and microsatellite unstable metastatic colorectal cancer patient: A case report. ( Broudin, C; Gallois, C; Garinet, S; Karoui, M; Sabouret, A; Taieb, J; Zaanan, A, 2022) |
| "To create a cost-effectiveness model to compare doublet therapy (encorafenib plus cetuximab) with standard chemotherapy (cetuximab plus irinotecan or cetuximab plus folinic acid, fluorouracil, and irinotecan) in treating patients with metastatic BRAF variant colorectal cancer." | 4.02 | Evaluation of the Cost-effectiveness of Doublet Therapy in Metastatic BRAF Variant Colorectal Cancer. ( Huntington, SF; Lacy, J; O'Hara, M; Patel, KK; Stein, S, 2021) |
| "Recently the phase 3 BEACON trial showed that the combination of encorafenib, cetuximab, and binimetinib versus cetuximab and irinotecan/FOLFIRI improved overall survival in pre-treated patients with metastatic colorectal cancer (mCRC) with BRAF V600E mutation." | 4.02 | Cost-Effectiveness Analysis of Encorafenib, Binimetinib, and Cetuximab in BRAF V600E-Mutated Metastatic Colorectal Cancer in the USA. ( Ding, D; Hu, H; Huang, J; Li, S; Zhu, Y, 2021) |
| " We have evaluated several commercially available benzimidazole carbamates for cytotoxic activity in colorectal cancer cells." | 3.81 | ERK-dependent phosphorylation of HSF1 mediates chemotherapeutic resistance to benzimidazole carbamates in colorectal cancer cells. ( Higa, AT; Jacobs, AT; McAllister, HA; Taylor, FR; Wales, CT, 2015) |
| " Adverse event (AE) profiles of specific BRAF inhibitors vary, however, and are affected by the specific agents given in combination." | 2.72 | Management of adverse events from the treatment of encorafenib plus cetuximab for patients with BRAF V600E-mutant metastatic colorectal cancer: insights from the BEACON CRC study. ( Christy-Bittel, J; Ciardiello, F; Desai, J; Gollerkeri, A; Grothey, A; Kopetz, S; Maharry, K; Tabernero, J; Trevino, TL; Van Cutsem, E; Velez, L; Wasan, H; Yaeger, R; Yoshino, T, 2021) |
| "On 2 June 2020, a marketing authorisation valid through the European Union (EU) was issued for encorafenib in combination with cetuximab in adult patients with metastatic colorectal carcinoma (mCRC) with the BRAFV600E mutation who had received prior systemic therapy." | 2.72 | The EMA assessment of encorafenib in combination with cetuximab for the treatment of adult patients with metastatic colorectal carcinoma harbouring the BRAFV600E mutation who have received prior therapy. ( Dedorath, J; Delgado, J; Enzmann, H; Fuerstenau, U; Hausmann, S; Koenig, J; Pignatti, F; Stock, T; Trullas, A, 2021) |
| "Worldwide metastatic colorectal cancer is the second most common cause of death attributable to cancer." | 2.66 | Current perspectives on the treatment of BRAF mutated colorectal carcinoma. ( Batko, S, 2020) |
| "Colorectal cancer is among the most lethal malignancies globally." | 2.58 | The therapeutic potential of targeting the BRAF mutation in patients with colorectal cancer. ( Avan, A; Bahrami, A; Ferns, GA; Hassanian, SM; Hesari, A; Khazaei, M, 2018) |
| "Metastatic colorectal cancer (mCRC) is a heterogeneous disease with distinct molecular subtypes." | 1.72 | Retrospective Analysis of Treatment Pathways in Patients With BRAF ( Agocs, GR; Bastian, S; Eisterer, W; Fenchel, K; Fritsch, R; Fuxius, S; Gerger, A; Greil, R; Koeberle, D; Maas, C; Modest, DP; Reichenbach, F; Sanoyan, DA; Schwager, M; Uhlig, J; VON DER Heyde, E; Weide, R; Welslau, M, 2022) |
| "5-Fluorouracil (5-FU) is a typical CRC treatment." | 1.56 | BET inhibitor bromosporine enhances 5-FU effect in colorectal cancer cells. ( Cheng, X; Huang, Z; Jin, W; Long, D, 2020) |
| "Blood were collected from 16 colorectal cancer patients and 20 healthy controls, then solid phase microextraction-chromatography-mass spectrometry (SPME-GC-MS) was used to analysis the exhaled volatile organic compounds (VOCs)." | 1.40 | Blood volatile compounds as biomarkers for colorectal cancer. ( Chi, C; Guo, L; Guo, Z; Ke, C; Li, E; Li, P; Lian, A; Liu, S; Luo, S; Sun, B; Wang, C; Wang, X; Xu, G; Ye, G; Zhang, F; Zhang, Y; Zhao, W, 2014) |
| Timeframe | Studies, this research(%) | All Research% |
|---|---|---|
| pre-1990 | 0 (0.00) | 18.7374 |
| 1990's | 3 (6.38) | 18.2507 |
| 2000's | 2 (4.26) | 29.6817 |
| 2010's | 14 (29.79) | 24.3611 |
| 2020's | 28 (59.57) | 2.80 |
| Authors | Studies |
|---|---|
| Giuliani, J | 1 |
| Mantoan, B | 1 |
| Bonetti, A | 1 |
| Calegari, MA | 1 |
| Stefano, BD | 1 |
| Basso, M | 1 |
| Carbone, C | 1 |
| Camarda, F | 1 |
| Ribelli, M | 1 |
| Anghelone, A | 1 |
| Vivolo, R | 1 |
| Bensi, M | 2 |
| Martini, M | 1 |
| Pozzo, C | 1 |
| Vellone, M | 1 |
| Ardito, F | 1 |
| Salvatore, L | 2 |
| Giuliante, F | 1 |
| Tortora, G | 1 |
| Sakumura, M | 1 |
| Ando, T | 1 |
| Ueda-Consolvo, T | 1 |
| Motoo, I | 1 |
| Mihara, H | 1 |
| Kajiura, S | 1 |
| Teramoto, A | 1 |
| Nanjo, S | 1 |
| Fujinami, H | 1 |
| Yasuda, I | 1 |
| Gallois, C | 3 |
| Taieb, J | 3 |
| Sabouret, A | 1 |
| Broudin, C | 1 |
| Karoui, M | 1 |
| Garinet, S | 1 |
| Zaanan, A | 1 |
| Tabernero, J | 7 |
| Velez, L | 1 |
| Trevino, TL | 1 |
| Grothey, A | 6 |
| Yaeger, R | 6 |
| Van Cutsem, E | 5 |
| Wasan, H | 5 |
| Desai, J | 5 |
| Ciardiello, F | 5 |
| Yoshino, T | 6 |
| Gollerkeri, A | 4 |
| Maharry, K | 5 |
| Christy-Bittel, J | 4 |
| Kopetz, S | 6 |
| Ji, J | 1 |
| Wang, C | 2 |
| Fakih, M | 2 |
| Omori, R | 1 |
| Miyagaki, T | 1 |
| Miyano, K | 1 |
| Hashimoto, Y | 1 |
| Kadono, T | 1 |
| Hafliger, E | 1 |
| Boccaccino, A | 2 |
| Lapeyre-Prost, A | 1 |
| Perret, A | 1 |
| Antista, M | 2 |
| Pilla, L | 1 |
| Lecomte, T | 1 |
| Scartozzi, M | 1 |
| Soularue, E | 1 |
| Bourgeois, V | 1 |
| Salati, M | 2 |
| Tougeron, D | 1 |
| Evesque, L | 1 |
| Vaillant, JN | 1 |
| El-Khoury, R | 1 |
| Lonardi, S | 3 |
| Cremolini, C | 2 |
| Loupakis, F | 3 |
| Hong, YS | 3 |
| Steeghs, N | 3 |
| Guren, TK | 3 |
| Arkenau, HT | 3 |
| Garcia-Alfonso, P | 3 |
| Belani, A | 1 |
| Zhang, X | 1 |
| Borelli, B | 1 |
| Intini, R | 1 |
| Rossini, D | 1 |
| Passardi, A | 1 |
| Tamberi, S | 1 |
| Giampieri, R | 1 |
| Antonuzzo, L | 1 |
| Noto, L | 1 |
| Roviello, G | 1 |
| Zichi, C | 1 |
| Puccini, A | 1 |
| Noto, C | 1 |
| Parisi, A | 1 |
| Rihawi, K | 1 |
| Persano, M | 1 |
| Crespi, V | 1 |
| Libertini, M | 1 |
| Giordano, M | 1 |
| Moretto, R | 1 |
| Ciccolini, J | 1 |
| Milano, G | 1 |
| Ros, J | 1 |
| Elez, E | 5 |
| Gerger, A | 1 |
| Eisterer, W | 1 |
| Fuxius, S | 1 |
| Bastian, S | 1 |
| Koeberle, D | 1 |
| Welslau, M | 1 |
| Sanoyan, DA | 1 |
| Maas, C | 1 |
| Uhlig, J | 1 |
| Fenchel, K | 1 |
| Greil, R | 1 |
| VON DER Heyde, E | 1 |
| Agocs, GR | 1 |
| Weide, R | 1 |
| Schwager, M | 1 |
| Reichenbach, F | 1 |
| Modest, DP | 1 |
| Fritsch, R | 1 |
| Moradi-Marjaneh, R | 1 |
| Paseban, M | 1 |
| Moradi Marjaneh, M | 1 |
| Pfeiffer, P | 1 |
| Orlov, S | 1 |
| Kim, TW | 1 |
| Schellens, JHM | 3 |
| Guo, C | 1 |
| Krishnan, A | 1 |
| Dekervel, J | 1 |
| Morris, V | 1 |
| Calvo Ferrandiz, A | 1 |
| Tarpgaard, LS | 1 |
| Braun, M | 1 |
| Keir, C | 1 |
| Pickard, M | 1 |
| Anderson, L | 1 |
| Sandor, V | 2 |
| Killock, D | 1 |
| Gunjur, A | 1 |
| Cheng, X | 1 |
| Huang, Z | 1 |
| Long, D | 1 |
| Jin, W | 1 |
| Shahjehan, F | 1 |
| Kamatham, S | 1 |
| Chandrasekharan, C | 1 |
| Kasi, PM | 1 |
| Sharma, V | 1 |
| Vanidassane, I | 1 |
| Prasad, V | 1 |
| Pietrantonio, F | 1 |
| Boilève, A | 1 |
| Samalin, E | 1 |
| Batko, S | 1 |
| Huijberts, SCFA | 1 |
| Boelens, MC | 1 |
| Bernards, R | 1 |
| Opdam, FL | 1 |
| Trullas, A | 1 |
| Delgado, J | 1 |
| Koenig, J | 1 |
| Fuerstenau, U | 1 |
| Dedorath, J | 1 |
| Hausmann, S | 1 |
| Stock, T | 1 |
| Enzmann, H | 1 |
| Pignatti, F | 1 |
| Patel, KK | 1 |
| Stein, S | 1 |
| Lacy, J | 1 |
| O'Hara, M | 1 |
| Huntington, SF | 1 |
| Li, S | 1 |
| Hu, H | 1 |
| Ding, D | 1 |
| Zhu, Y | 1 |
| Huang, J | 1 |
| Stammler, R | 1 |
| Duong, JP | 1 |
| Karras, A | 1 |
| Thervet, E | 1 |
| Lazareth, H | 1 |
| Al-Salama, ZT | 1 |
| van Geel, RMJM | 1 |
| Bendell, JC | 1 |
| Spreafico, A | 1 |
| Schuler, M | 1 |
| Delord, JP | 1 |
| Yamada, Y | 1 |
| Lolkema, MP | 1 |
| Faris, JE | 1 |
| Eskens, FALM | 1 |
| Sharma, S | 1 |
| Lenz, HJ | 1 |
| Wainberg, ZA | 1 |
| Avsar, E | 1 |
| Chatterjee, A | 1 |
| Jaeger, S | 1 |
| Tan, E | 1 |
| Demuth, T | 1 |
| Karwad, MA | 1 |
| Couch, DG | 1 |
| Theophilidou, E | 1 |
| Sarmad, S | 1 |
| Barrett, DA | 1 |
| Larvin, M | 1 |
| Wright, KL | 1 |
| Lund, JN | 1 |
| O'Sullivan, SE | 1 |
| Bahrami, A | 1 |
| Hesari, A | 1 |
| Khazaei, M | 1 |
| Hassanian, SM | 1 |
| Ferns, GA | 1 |
| Avan, A | 1 |
| Zhang, Q | 1 |
| Xu, H | 1 |
| Liu, R | 1 |
| Gao, P | 1 |
| Yang, X | 1 |
| Li, P | 2 |
| Wang, X | 2 |
| Zhang, Y | 2 |
| Bi, K | 1 |
| Li, Q | 1 |
| Huijberts, S | 1 |
| Cuyle, PJ | 1 |
| Montagut, C | 1 |
| Peeters, M | 1 |
| Li, J | 1 |
| Li, X | 1 |
| Lian, A | 1 |
| Sun, B | 1 |
| Guo, L | 1 |
| Chi, C | 1 |
| Liu, S | 1 |
| Zhao, W | 1 |
| Luo, S | 1 |
| Guo, Z | 1 |
| Ke, C | 1 |
| Ye, G | 1 |
| Xu, G | 1 |
| Zhang, F | 1 |
| Li, E | 1 |
| Wales, CT | 1 |
| Taylor, FR | 1 |
| Higa, AT | 1 |
| McAllister, HA | 1 |
| Jacobs, AT | 1 |
| Smith, AB | 1 |
| Freeze, BS | 1 |
| LaMarche, MJ | 1 |
| Sager, J | 1 |
| Kinzler, KW | 1 |
| Vogelstein, B | 1 |
| Weiss, T | 1 |
| Bernhardt, G | 1 |
| Buschauer, A | 1 |
| Jauch, KW | 1 |
| Zirngibl, H | 1 |
| Pazdur, R | 2 |
| Meyers, C | 1 |
| Diaz-Canton, E | 1 |
| Abbruzzese, JL | 1 |
| Patt, Y | 1 |
| Grove, W | 2 |
| Ajani, J | 1 |
| Meyers, CA | 1 |
| Kudelka, AP | 1 |
| Conrad, CA | 1 |
| Gelke, CK | 1 |
| Hammond, LA | 1 |
| Davidson, K | 1 |
| Lawrence, R | 1 |
| Camden, JB | 1 |
| Von Hoff, DD | 1 |
| Weitman, S | 1 |
| Izbicka, E | 1 |
| Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
|---|---|---|---|---|---|---|---|
| A Multicenter, Randomized, Open-label, 3-Arm Phase 3 Study of Encorafenib + Cetuximab Plus or Minus Binimetinib vs. Irinotecan/Cetuximab or Infusional 5-Fluorouracil (5-FU)/Folinic Acid (FA)/Irinotecan (FOLFIRI)/Cetuximab With a Safety Lead-in of Encorafe[NCT02928224] | Phase 3 | 702 participants (Actual) | Interventional | 2016-10-13 | Completed | ||
| Tempus CRC Surveillance Study: A Longitudinal Circulating Tumor DNA (ctDNA) Biomarker Profiling Study of Patients With Colorectal Cancer (CRC) Using Comprehensive Next-Generation Sequencing (NGS)Assays[NCT05234177] | 160 participants (Anticipated) | Observational | 2022-06-21 | Recruiting | |||
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] | |||||||
DOR was defined as the time from first radiographic evidence of response to the earliest documented PD or death due to underlying disease. PD: at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions were evaluated. (NCT02928224)
Timeframe: From time of response to PD or death due to underlying disease (maximum treatment exposure of 268 weeks for doublet arm and 108 weeks for control arm)
| Intervention | Months (Median) |
|---|---|
| Phase 3: Doublet Arm | 6.06 |
| Phase 3:Control Arm | NA |
DOR was defined as the time from first radiographic evidence of response to the earliest documented PD or death due to underlying disease. PD: at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions were evaluated. (NCT02928224)
Timeframe: From time of response to PD or death due to underlying disease (maximum treatment exposure of 268 weeks for doublet arm and 108 weeks for control arm)
| Intervention | Months (Median) |
|---|---|
| Phase 3: Doublet Arm | 5.70 |
| Phase 3:Control Arm | 5.75 |
DOR was defined as the time from first radiographic evidence of response to the earliest documented PD or death due to underlying disease. PD: at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions were evaluated. (NCT02928224)
Timeframe: From time of response to PD or death due to underlying disease (maximum treatment exposure of 277.4 weeks for triplet arm and 108 weeks for control arm)
| Intervention | Months (Median) |
|---|---|
| Phase 3: Triplet Arm | 4.80 |
| Phase 3:Control Arm | NA |
DOR was defined as the time from first radiographic evidence of response to the earliest documented disease progression (PD) or death due to underlying disease. PD: at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions were evaluated. (NCT02928224)
Timeframe: From time of response to PD or death due to underlying disease (maximum treatment exposure of 277.4 weeks for triplet arm and 108 weeks for control arm)
| Intervention | Months (Median) |
|---|---|
| Phase 3: Triplet Arm | 4.80 |
| Phase 3:Control Arm | 5.75 |
DOR was defined as the time from first radiographic evidence of response to the earliest documented PD or death due to underlying disease. PD: at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions were evaluated. (NCT02928224)
Timeframe: From time of response to PD or death due to underlying disease (maximum treatment exposure of 277.4 weeks for triplet arm and 268 weeks for doublet arm)
| Intervention | Months (Median) |
|---|---|
| Phase 3: Triplet Arm | 4.80 |
| Phase 3:Doublet Arm | 6.06 |
DOR was defined as the time from first radiographic evidence of response to the earliest documented PD or death due to underlying disease. PD: at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions were evaluated. (NCT02928224)
Timeframe: From time of response to PD or death due to underlying disease (maximum treatment exposure of 277.4 weeks for triplet arm and 268 weeks for doublet arm)
| Intervention | Months (Median) |
|---|---|
| Phase 3: Triplet Arm | 4.80 |
| Phase 3:Doublet Arm | 5.70 |
ORR per RECIST, v1.1, was defined as the percentage of participants achieving an overall best response of CR or PR, where CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (<10 mm short axis), and PR: at least 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesions and/or maintenance of tumor marker level above the normal limits. (NCT02928224)
Timeframe: Duration of Phase 3, approximately 6 months (up to 28 days per cycle)
| Intervention | Percentage of participants (Number) |
|---|---|
| Phase 3: Doublet Arm | 20.4 |
| Phase 3:Control Arm | 1.9 |
ORR per RECIST, v1.1, was defined as the percentage of participants achieving an overall best response of CR or PR, where CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (<10 mm short axis), and PR: at least 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesions and/or maintenance of tumor marker level above the normal limits. (NCT02928224)
Timeframe: Duration of Phase 3, approximately 6 months (up to 28 days per cycle)
| Intervention | Percentage of participants (Number) |
|---|---|
| Phase 3: Doublet Arm | 15.9 |
| Phase 3:Control Arm | 3.7 |
ORR per RECIST, v1.1, was defined as the percentage of participants achieving an overall best response of CR or PR, where CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (<10 mm short axis), and PR: at least 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesions and/or maintenance of tumor marker level above the normal limits. (NCT02928224)
Timeframe: Duration of Phase 3, approximately 6 months (up to 28 days per cycle)
| Intervention | Percentage of participants (Number) |
|---|---|
| Phase 3: Triplet Arm | 26.1 |
| Phase 3:Control Arm | 3.7 |
ORR per RECIST, v1.1, was defined as the percentage of participants achieving an overall best response of CR or PR, where CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (<10 mm short axis), and PR: at least 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesions and/or maintenance of tumor marker level above the normal limits. (NCT02928224)
Timeframe: Duration of Phase 3, approximately 6 months (up to 28 days per cycle)
| Intervention | Percentage of participants (Number) |
|---|---|
| Phase 3: Triplet Arm | 26.1 |
| Phase 3: Doublet Arm | 20.4 |
ORR per RECIST, v1.1, was defined as the percentage of participants achieving an overall best response of CR or PR, where CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (<10 mm short axis), and PR: at least 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesions and/or maintenance of tumor marker level above the normal limits. (NCT02928224)
Timeframe: Duration of Phase 3, approximately 6 months (up to 28 days per cycle)
| Intervention | Percentage of participants (Number) |
|---|---|
| Phase 3: Triplet Arm | 26.1 |
| Phase 3: Doublet Arm | 15.9 |
PFS was defined as the time from first dose to the earliest documented PD or death due to any cause. PD: at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions were evaluated. (NCT02928224)
Timeframe: From first dose to the earliest documented PD or death due to any cause (maximum treatment exposure of 268 weeks for doublet arm and 108 weeks for control arm)
| Intervention | Months (Median) |
|---|---|
| Phase 3: Doublet Arm | 4.21 |
| Phase 3:Control Arm | 1.51 |
PFS was defined as the time from first dose to the earliest documented PD or death due to any cause. PD: at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions were evaluated. (NCT02928224)
Timeframe: From first dose to the earliest documented PD or death due to any cause (maximum treatment exposure of 268 weeks for doublet arm and 108 weeks for control arm)
| Intervention | Months (Median) |
|---|---|
| Phase 3: Doublet Arm | 4.27 |
| Phase 3:Control Arm | 1.58 |
PFS was defined as the time from first dose to the earliest documented PD or death due to any cause. PD: at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions were evaluated. (NCT02928224)
Timeframe: From first dose to the earliest documented PD or death due to any cause (maximum treatment exposure of 277.4 weeks for triplet arm and 108 weeks for control arm)
| Intervention | Months (Median) |
|---|---|
| Phase 3: Triplet Arm | 4.30 |
| Phase 3:Control Arm | 1.51 |
PFS was defined as the time from first dose to the earliest documented PD or death due to any cause. PD: at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions were evaluated. (NCT02928224)
Timeframe: From first dose to the earliest documented PD or death due to any cause (maximum treatment exposure of 277.4 weeks for triplet arm and 108 weeks for control arm)
| Intervention | Months (Median) |
|---|---|
| Phase 3: Triplet Arm | 4.47 |
| Phase 3:Control Arm | 1.58 |
PFS was defined as the time from first dose to the earliest documented PD or death due to any cause. PD: at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions were evaluated. (NCT02928224)
Timeframe: From first dose to the earliest documented PD or death due to any cause (maximum treatment exposure of 277.4 weeks for triplet arm and 268 weeks for doublet arm)
| Intervention | Months (Median) |
|---|---|
| Phase 3: Triplet Arm | 4.30 |
| Phase 3: Doublet Arm | 4.21 |
PFS was defined as the time from first dose to the earliest documented PD or death due to any cause. PD: at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions were evaluated. (NCT02928224)
Timeframe: From first dose to the earliest documented PD or death due to any cause (maximum treatment exposure of 277.4 weeks for triplet arm and 268 weeks for doublet arm)
| Intervention | Months (Median) |
|---|---|
| Phase 3: Triplet Arm | 4.47 |
| Phase 3: Doublet Arm | 4.27 |
Time to response was defined as the time from first dose to first radiographic evidence of response. (NCT02928224)
Timeframe: From first dose to first radiographic evidence of response (maximum treatment exposure of 268 weeks for doublet arm and 108 weeks for control arm)
| Intervention | Months (Median) |
|---|---|
| Phase 3: Doublet Arm | 1.48 |
| Phase 3:Control Arm | 1.45 |
Time to response was defined as the time from first dose to first radiographic evidence of response. (NCT02928224)
Timeframe: From first dose to first radiographic evidence of response (maximum treatment exposure of 268 weeks for doublet arm and 108 weeks for control arm)
| Intervention | Months (Median) |
|---|---|
| Phase 3: Doublet Arm | 1.48 |
| Phase 3:Control Arm | 2.63 |
Time to response was defined as the time from first dose to first radiographic evidence of response. (NCT02928224)
Timeframe: From first dose to first radiographic evidence of response (maximum treatment exposure of 277.4 weeks for triplet arm and 108 weeks for control arm)
| Intervention | Months (Median) |
|---|---|
| Phase 3: Triplet Arm | 1.43 |
| Phase 3:Control Arm | 1.45 |
Time to response was defined as the time from first dose to first radiographic evidence of response. (NCT02928224)
Timeframe: From first dose to first radiographic evidence of response (maximum treatment exposure of 277.4 weeks for triplet arm and 108 weeks for control arm)
| Intervention | Months (Median) |
|---|---|
| Phase 3: Triplet Arm | 1.48 |
| Phase 3:Control Arm | 2.63 |
Time to response was defined as the time from first dose to first radiographic evidence of response. (NCT02928224)
Timeframe: From first dose to first radiographic evidence of response (maximum treatment exposure of 277.4 weeks for triplet arm and 268 weeks for doublet arm)
| Intervention | Months (Median) |
|---|---|
| Phase 3: Triplet Arm | 1.43 |
| Phase 3:Doublet Arm | 1.48 |
Time to response was defined as the time from first dose to first radiographic evidence of response. (NCT02928224)
Timeframe: From first dose to first radiographic evidence of response (maximum treatment exposure of 277.4 weeks for triplet arm and 268 weeks for doublet arm)
| Intervention | Months (Median) |
|---|---|
| Phase 3: Triplet Arm | 1.48 |
| Phase 3:Doublet Arm | 1.48 |
The reported cross-arm CL/F value is a fixed-effect parameter determined from a population PK analysis. The analysis included pooled data from participants enrolled in multiple studies including those who were not enrolled in this study. The NCTID include: NCT01719380, NCT01543698, and NCT01436656. An additional study ARRAY-162-105 is not required to register. (NCT02928224)
Timeframe: 2 and 6 hours post-dose on Day 1 of Cycle 1, Predose and 2 hours post-dose on Day 1 of Cycle 2 (each cycle of 28 days)
| Intervention | Liter/hour (Geometric Mean) |
|---|---|
| Pharmacokinetic Population of Encorafenib | 0.0154 |
The reported cross-arm CL/F value is a fixed-effect parameter determined from a population PK analysis. The analysis included pooled data from participants enrolled in multiple studies including those who were not enrolled in this study. The NCTID include: NCT01719380, NCT01543698, and NCT01436656. An additional study ARRAY-162-105 is not required to register. (NCT02928224)
Timeframe: 2 and 6 hours post-dose on Day 1 of Cycle 1, Predose and 2 hours post-dose on Day 1 of Cycle 2 (each cycle of 28 days)
| Intervention | Liter/hour (Geometric Mean) |
|---|---|
| Pharmacokinetic Population of Encorafenib | 19.0 |
The reported cross-arm CL/F value is a fixed-effect parameter determined from a population PK analysis. The analysis included pooled data from participants enrolled in multiple studies including those who were not enrolled in this study. The NCTID include: NCT01719380, NCT01543698, and NCT01436656. An additional study ARRAY-162-105 is not required to register. (NCT02928224)
Timeframe: 2 and 6 hours post-dose on Day 1 of Cycle 1, Predose and 2 hours post-dose on Day 1 of Cycle 2 (each cycle of 28 days)
| Intervention | Liter/hour (Geometric Mean) |
|---|---|
| Pharmacokinetic Population of Encorafenib | 16.4 |
ORR per RECIST, v1.1, was defined as the percentage of participants achieving an overall best response of complete response (CR) or partial response (PR), where CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (<10 millimeter [mm] short axis), and PR: at least 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesions and/or maintenance of tumor marker level above the normal limits. (NCT02928224)
Timeframe: Duration of Phase 3, approximately 6 months (up to 28 days per cycle)
| Intervention | Percentage of participants (Number) |
|---|---|
| Phase 3: Triplet Arm | 26.1 |
| Phase 3:Control Arm | 1.9 |
OS was defined as the time from randomization to death due to any cause. (NCT02928224)
Timeframe: From randomization to death due to any cause until 204 deaths were observed (maximum treatment exposure of 89.7 weeks for doublet arm and 52.4 weeks for control arm)
| Intervention | Months (Median) |
|---|---|
| Phase 3: Doublet Arm | 9.40 |
| Phase 3:Control Arm | 5.88 |
OS was defined as the time from randomization to death due to any cause. (NCT02928224)
Timeframe: From randomization to death due to any cause until 204 deaths were observed (maximum treatment exposure of 89.7 weeks for doublet arm and 89.1 weeks for triplet arm)
| Intervention | Months (Median) |
|---|---|
| Phase 3: Triplet Arm | 9.82 |
| Phase 3: Doublet Arm | 9.40 |
OS was defined as the time from randomization to death due to any cause. (NCT02928224)
Timeframe: From randomization to death due to any cause (maximum treatment exposure of 277.4 weeks for triplet arm and 108 weeks for control arm)
| Intervention | Months (Median) |
|---|---|
| Phase 3: Triplet Arm | 9.82 |
| Phase 3:Control Arm | 5.88 |
OS was defined as the time from randomization to death due to any cause. (NCT02928224)
Timeframe: From randomization to death due to any cause until 204 deaths were observed (maximum treatment exposure of 89.1 weeks for triplet arm and 52.4 weeks for control arm)
| Intervention | Months (Median) |
|---|---|
| Phase 3: Triplet Arm | 9.03 |
| Phase 3: Control Arm | 5.42 |
DOR was defined as the time from first radiographic evidence of response to the earliest documented PD or death due to underlying disease. PD: at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions were evaluated. (NCT02928224)
Timeframe: From time of response to the earliest documented PD or death due to underlying disease (maximum treatment exposure of 280 weeks)
| Intervention | Months (Median) |
|---|---|
| Combined Safety Lead-in | 8.15 |
DOR was defined as the time from first radiographic evidence of response to the earliest documented disease progression (PD) or death due to underlying disease. PD: at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions were evaluated. (NCT02928224)
Timeframe: From time of response to the earliest documented PD or death due to underlying disease (maximum treatment exposure of 280 weeks)
| Intervention | Months (Median) |
|---|---|
| Combined Safety Lead-in | 6.47 |
(NCT02928224)
Timeframe: Predose and 1, 2, 4 and 6 hours post-dose on Day 1 of Cycles 1 and 2 (each cycle of 28 days)
| Intervention | Nanogram/milliliter (Geometric Mean) |
|---|---|
| Combined Safety Lead-in | 3.41 |
(NCT02928224)
Timeframe: Predose and 1, 2, 4 and 6 hours post-dose on Day 1 of Cycles 1 and 2 (each cycle of 28 days)
| Intervention | Nanogram/milliliter (Geometric Mean) |
|---|---|
| Combined Safety Lead-in | 55.3 |
(NCT02928224)
Timeframe: Predose and 1, 2, 4 and 6 hours post-dose on Day 1 of Cycles 1 and 2 (each cycle of 28 days)
| Intervention | Nanogram/milliliter (Geometric Mean) |
|---|---|
| Combined Safety Lead-in | 55400 |
(NCT02928224)
Timeframe: Predose and 1, 2, 4 and 6 hours post-dose on Day 1 of Cycles 1 and 2 (each cycle of 28 days)
| Intervention | Nanogram/milliliter (Geometric Mean) |
|---|---|
| Combined Safety Lead-in | 18.9 |
An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Number of participants with dose interruptions, dose modifications and dose discontinuations due to AEs were reported in this outcome measure. (NCT02928224)
Timeframe: Duration of safety lead-in, approximately 6 months (up to 28 days per cycle)
| Intervention | Participants (Count of Participants) |
|---|---|
| Combined Safety Lead-in | 26 |
An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Number of participants reporting AEs were reported in this outcome measure. (NCT02928224)
Timeframe: Duration of safety lead-in, approximately 6 months (up to 28 days per cycle)
| Intervention | Participants (Count of Participants) |
|---|---|
| Combined Safety Lead-in | 37 |
(NCT02928224)
Timeframe: Cycle 1 (up to 28 days)
| Intervention | Participants (Count of Participants) |
|---|---|
| Combined Safety Lead-in (CSLI) | 5 |
ORR per RECIST, v1.1, was defined as the percentage of participants achieving an overall best response of CR or PR, where CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (<10 mm short axis), and PR: at least 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesions and/or maintenance of tumor marker level above the normal limits. (NCT02928224)
Timeframe: From start of study treatment until 30 days post last dose of study treatment (maximum treatment exposure of 280 weeks)
| Intervention | Percentage of participants (Number) |
|---|---|
| Combined Safety Lead-in | 41.7 |
ORR per RECIST, v1.1, was defined as the percentage of participants achieving an overall best response of CR or PR, where CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (<10 mm short axis), and PR: at least 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesions and/or maintenance of tumor marker level above the normal limits. (NCT02928224)
Timeframe: From start of study treatment until 30 days post last dose of study treatment (maximum treatment exposure of 280 weeks)
| Intervention | Percentage of participants (Number) |
|---|---|
| Combined Safety Lead-in | 52.8 |
PFS was defined as the time from first dose to the earliest documented PD or death due to any cause. PD: at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions were evaluated. (NCT02928224)
Timeframe: From first dose to the earliest documented PD or death due to any cause (maximum treatment exposure of 280 weeks)
| Intervention | Months (Median) |
|---|---|
| Combined Safety Lead-in | 5.59 |
PFS was defined as the time from first dose to the earliest documented PD or death due to any cause. PD: at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions were evaluated. (NCT02928224)
Timeframe: From first dose to the earliest documented PD or death due to any cause (maximum treatment exposure of 280 weeks)
| Intervention | Months (Median) |
|---|---|
| Combined Safety Lead-in | 8.08 |
Time to response was defined as the time from first dose to first radiographic evidence of response. (NCT02928224)
Timeframe: From first dose to first radiographic evidence of response (maximum treatment exposure of 280 weeks)
| Intervention | Months (Median) |
|---|---|
| Combined Safety Lead-in | 1.45 |
Time to response was defined as the time from first dose to first radiographic evidence of response. (NCT02928224)
Timeframe: From first dose to first radiographic evidence of response (maximum treatment exposure of 280 weeks)
| Intervention | Months (Median) |
|---|---|
| Combined Safety Lead-in | 1.45 |
Clinically notable shifts was defined as worsening by at least 2 grades or to >= Grade 3 based on CTCAE version 4.03 where Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: life threatening and Grade 5: death. (NCT02928224)
Timeframe: From start of study treatment until 30 days post last dose of study treatment (for triplet arm: maximum treatment exposure of 277.4 weeks; for doublet arm: maximum treatment exposure of 268 weeks; for Control arm: maximum treatment exposure of 108 weeks)
| Intervention | Participants (Count of Participants) |
|---|---|
| Phase 3: Triplet Arm | 8 |
| Phase 3: Doublet Arm | 8 |
| Phase 3: Control Arm | 5 |
The EORTC QLQ-C30 questionnaire consisted of 30 questions generating 5 functional scores (physical, role, cognitive, emotional, & social); a global health (GH) status/global quality of life scale score; 3 symptom scale scores (fatigue, pain, & nausea & vomiting); & 6 standalone one-item scores that capture additional symptoms (dyspnea, appetite loss, sleep disturbance, constipation, & diarrhea) & perceived financial burden. All items were graded by severity experienced during previous week & used 4-point-scale (1: not at all, 2: a little, 3: quite a bit, 4: very much). The scores were converted to health-related quality of life (HRQoL) scale ranging from 0-100. Higher scores indicating higher response levels (i.e., higher functioning, higher symptom severity). (NCT02928224)
Timeframe: Baseline, Cycle(C)1 Day(D)1 , C2 D1, C3 D1, C4 D1, C5 D1, C6 D1, C7 D1, C8 D1, C9 D1, C10 D1, C11 D1, C12 D1, C13 D1, C14 D1, C15 D1, C16 D1, C17 D1, C18 D1, C19 D1, C20 D1, C21 D1, C22 D1, C23 D1, End of Treatment, 30 Day Follow Up(each cycle of 28 days)
| Intervention | Units on a scale (Mean) | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | Change at Cycle 1 Day 1 | Change at Cycle 2 Day 1 | Change at Cycle 3 Day 1 | Change at Cycle 4 Day 1 | Change at Cycle 5 Day 1 | Change at Cycle 6 Day 1 | Change at Cycle 7 Day 1 | Change at Cycle 8 Day 1 | Change at Cycle 9 Day 1 | Change at Cycle 10 Day 1 | Change at Cycle 11 Day 1 | Change at Cycle 12 Day 1 | Change at Cycle 13 Day 1 | Change at End of Treatment | Change at 30 Day Follow Up | |
| Phase 3:Control Arm | 62.8 | -3.4 | -1.9 | -0.2 | 1.4 | -2.2 | -4.5 | 1.7 | 0.0 | -4.8 | 2.1 | 33.3 | 4.2 | 0.0 | -15.5 | -24.6 |
The EORTC QLQ-C30 questionnaire consisted of 30 questions generating 5 functional scores (physical, role, cognitive, emotional, & social); a global health (GH) status/global quality of life scale score; 3 symptom scale scores (fatigue, pain, & nausea & vomiting); & 6 standalone one-item scores that capture additional symptoms (dyspnea, appetite loss, sleep disturbance, constipation, & diarrhea) & perceived financial burden. All items were graded by severity experienced during previous week & used 4-point-scale (1: not at all, 2: a little, 3: quite a bit, 4: very much). The scores were converted to health-related quality of life (HRQoL) scale ranging from 0-100. Higher scores indicating higher response levels (i.e., higher functioning, higher symptom severity). (NCT02928224)
Timeframe: Baseline, Cycle(C)1 Day(D)1 , C2 D1, C3 D1, C4 D1, C5 D1, C6 D1, C7 D1, C8 D1, C9 D1, C10 D1, C11 D1, C12 D1, C13 D1, C14 D1, C15 D1, C16 D1, C17 D1, C18 D1, C19 D1, C20 D1, C21 D1, C22 D1, C23 D1, End of Treatment, 30 Day Follow Up(each cycle of 28 days)
| Intervention | Units on a scale (Mean) | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | Change at Cycle 1 Day 1 | Change at Cycle 2 Day 1 | Change at Cycle 3 Day 1 | Change at Cycle 4 Day 1 | Change at Cycle 5 Day 1 | Change at Cycle 6 Day 1 | Change at Cycle 7 Day 1 | Change at Cycle 8 Day 1 | Change at Cycle 9 Day 1 | Change at Cycle 10 Day 1 | Change at Cycle 11 Day 1 | Change at Cycle 12 Day 1 | Change at Cycle 13 Day 1 | Change at Cycle 14 Day 1 | Change at Cycle 15 Day 1 | Change at Cycle 16 Day 1 | Change at Cycle 17 Day 1 | Change at Cycle 18 Day 1 | Change at Cycle 19 Day 1 | Change at Cycle 20 Day 1 | Change at Cycle 21 Day 1 | Change at End of Treatment | Change at 30 Day Follow Up | |
| Phase 3: Triplet Arm | 62.8 | -2.4 | -1.6 | 0.7 | 0.2 | -1.1 | -4.0 | -2.5 | -2.6 | -5.8 | -3.3 | -5.2 | 0.0 | 0.0 | -1.2 | 3.6 | -16.7 | -27.8 | -16.7 | 0.0 | -25 | 0.0 | -14.1 | -17.4 |
The EORTC QLQ-C30 questionnaire consisted of 30 questions generating 5 functional scores (physical, role, cognitive, emotional, & social); a global health (GH) status/global quality of life scale score; 3 symptom scale scores (fatigue, pain, & nausea & vomiting); & 6 standalone one-item scores that capture additional symptoms (dyspnea, appetite loss, sleep disturbance, constipation, & diarrhea) & perceived financial burden. All items were graded by severity experienced during previous week & used 4-point-scale (1: not at all, 2: a little, 3: quite a bit, 4: very much). The scores were converted to health-related quality of life (HRQoL) scale ranging from 0-100. Higher scores indicating higher response levels (i.e., higher functioning, higher symptom severity). (NCT02928224)
Timeframe: Baseline, Cycle(C)1 Day(D)1 , C2 D1, C3 D1, C4 D1, C5 D1, C6 D1, C7 D1, C8 D1, C9 D1, C10 D1, C11 D1, C12 D1, C13 D1, C14 D1, C15 D1, C16 D1, C17 D1, C18 D1, C19 D1, C20 D1, C21 D1, C22 D1, C23 D1, End of Treatment, 30 Day Follow Up(each cycle of 28 days)
| Intervention | Units on a scale (Mean) | |||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | Change at Cycle 1 Day 1 | Change at Cycle 2 Day 1 | Change at Cycle 3 Day 1 | Change at Cycle 4 Day 1 | Change at Cycle 5 Day 1 | Change at Cycle 6 Day 1 | Change at Cycle 7 Day 1 | Change at Cycle 8 Day 1 | Change at Cycle 9 Day 1 | Change at Cycle 10 Day 1 | Change at Cycle 11 Day 1 | Change at Cycle 12 Day 1 | Change at Cycle 13 Day 1 | Change at Cycle 14 Day 1 | Change at Cycle 15 Day 1 | Change at Cycle 16 Day 1 | Change at Cycle 17 Day 1 | Change at Cycle 18 Day 1 | Change at Cycle 19 Day 1 | Change at Cycle 20 Day 1 | Change at Cycle 21 Day 1 | Change at Cycle 22 Day 1 | Change at Cycle 23 Day 1 | Change at End of Treatment | Change at 30 Day Follow Up | |
| Phase 3:Doublet Arm | 60.7 | -4.3 | 3.8 | 3.5 | 4.2 | 4.3 | 5.6 | 4.3 | 4.2 | -5.6 | -2.8 | 3.9 | -4.6 | -3.2 | -6.0 | 2.8 | -5.6 | -2.8 | -8.3 | -8.3 | -8 | -16.7 | -16.7 | 0.0 | -13.1 | -10.4 |
The EQ-5D-5L contains 1 item for each of 5 dimensions of health-related QoL (i.e., mobility, self-care, usual activities, pain or discomfort and anxiety or depression). Response options for each item varied from having no problems to moderate problems or extreme problems. The EQ-5D-5L (v4.0) is a standardized measure of health utility that provides a single index value for one's health status. The EQ-5D-5L is frequently used for economic evaluations of health care and has been recognized as a valid and reliable instrument for this purpose. The EQ visual analog scale (VAS) is a score that is directly reported by the participant and ranges from 0 to 100 (higher is better quality health). (NCT02928224)
Timeframe: Baseline,Cycle (C)1 Day (D)1, C2 D1, C3 D1, C4 D1, C5 D1, C6 D1, C7 D1, C8 D1, C9 D1, C10 D1, C11 D1, C12 D1, C13 D1, C14 D1, C15 D1, C16 D1, C17 D1, C18 D1, C19 D1, C20 D1, C21 D1, C22 D1, C23 D1, End of Treatment, 30 Day Follow Up(each cycle of 28 days)
| Intervention | Units on a scale (Mean) | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | Change at Cycle 1 Day 1 | Change at Cycle 2 Day 1 | Change at Cycle 3 Day 1 | Change at Cycle 4 Day 1 | Change at Cycle 5 Day 1 | Change at Cycle 6 Day 1 | Change at Cycle 7 Day 1 | Change at Cycle 8 Day 1 | Change at Cycle 9 Day 1 | Change at Cycle 10 Day 1 | Change at Cycle 11 Day 1 | Change at Cycle 12 Day 1 | Change at Cycle 13 Day 1 | Change at End of Treatment | Change at 30 Day Follow Up | |
| Phase 3:Control Arm | 68.3 | -2.1 | -2.4 | -1.4 | -0.4 | 2.5 | -3.6 | 2.4 | -2.8 | -8.1 | -1.8 | 4.0 | 1.5 | -2.0 | -12.7 | -11.0 |
The EQ-5D-5L contains 1 item for each of 5 dimensions of health-related QoL (i.e., mobility, self-care, usual activities, pain or discomfort and anxiety or depression). Response options for each item varied from having no problems to moderate problems or extreme problems. The EQ-5D-5L (v4.0) is a standardized measure of health utility that provides a single index value for one's health status. The EQ-5D-5L is frequently used for economic evaluations of health care and has been recognized as a valid and reliable instrument for this purpose. The EQ visual analog scale (VAS) is a score that is directly reported by the participant and ranges from 0 to 100 (higher is better quality health). (NCT02928224)
Timeframe: Baseline,Cycle (C)1 Day (D)1, C2 D1, C3 D1, C4 D1, C5 D1, C6 D1, C7 D1, C8 D1, C9 D1, C10 D1, C11 D1, C12 D1, C13 D1, C14 D1, C15 D1, C16 D1, C17 D1, C18 D1, C19 D1, C20 D1, C21 D1, C22 D1, C23 D1, End of Treatment, 30 Day Follow Up(each cycle of 28 days)
| Intervention | Units on a scale (Mean) | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | Change at Cycle 1 Day 1 | Change at Cycle 2 Day 1 | Change at Cycle 3 Day 1 | Change at Cycle 4 Day 1 | Change at Cycle 5 Day 1 | Change at Cycle 6 Day 1 | Change at Cycle 7 Day 1 | Change at Cycle 8 Day 1 | Change at Cycle 9 Day 1 | Change at Cycle 10 Day 1 | Change at Cycle 11 Day 1 | Change at Cycle 12 Day 1 | Change at Cycle 13 Day 1 | Change at Cycle 14 Day 1 | Change at Cycle 15 Day 1 | Change at Cycle 16 Day 1 | Change at Cycle 17 Day 1 | Change at Cycle 18 Day 1 | Change at Cycle 19 Day 1 | Change at Cycle 20 Day 1 | Change at Cycle 21 Day 1 | Change at End of Treatment | Change at 30 Day Follow Up | |
| Phase 3: Triplet Arm | 69.0 | 0.8 | 1.4 | 3.0 | 4.0 | 3.3 | 1.3 | 1.4 | 4.1 | 0.3 | 0.2 | 0.2 | -4.0 | -3.0 | -4.0 | -3.4 | -10.4 | -18.3 | 7.0 | 8.0 | 8.0 | 8.0 | -8.5 | -11.1 |
The EQ-5D-5L contains 1 item for each of 5 dimensions of health-related QoL (i.e., mobility, self-care, usual activities, pain or discomfort and anxiety or depression). Response options for each item varied from having no problems to moderate problems or extreme problems. The EQ-5D-5L (v4.0) is a standardized measure of health utility that provides a single index value for one's health status. The EQ-5D-5L is frequently used for economic evaluations of health care and has been recognized as a valid and reliable instrument for this purpose. The EQ visual analog scale (VAS) is a score that is directly reported by the participant and ranges from 0 to 100 (higher is better quality health). (NCT02928224)
Timeframe: Baseline,Cycle (C)1 Day (D)1, C2 D1, C3 D1, C4 D1, C5 D1, C6 D1, C7 D1, C8 D1, C9 D1, C10 D1, C11 D1, C12 D1, C13 D1, C14 D1, C15 D1, C16 D1, C17 D1, C18 D1, C19 D1, C20 D1, C21 D1, C22 D1, C23 D1, End of Treatment, 30 Day Follow Up(each cycle of 28 days)
| Intervention | Units on a scale (Mean) | |||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | Change at Cycle 1 Day 1 | Change at Cycle 2 Day 1 | Change at Cycle 3 Day 1 | Change at Cycle 4 Day 1 | Change at Cycle 5 Day 1 | Change at Cycle 6 Day 1 | Change at Cycle 7 Day 1 | Change at Cycle 8 Day 1 | Change at Cycle 9 Day 1 | Change at Cycle 10 Day 1 | Change at Cycle 11 Day 1 | Change at Cycle 12 Day 1 | Change at Cycle 13 Day 1 | Change at Cycle 14 Day 1 | Change at Cycle 15 Day 1 | Change at Cycle 16 Day 1 | Change at Cycle 17 Day 1 | Change at Cycle 18 Day 1 | Change at Cycle 19 Day 1 | Change at Cycle 20 Day 1 | Change at Cycle 21 Day 1 | Change at Cycle 22 Day 1 | Change at Cycle 23 Day 1 | Change at End of Treatment | Change at 30 Day Follow Up | |
| Phase 3:Doublet Arm | 66.5 | -0.9 | 1.9 | 4.2 | 5.6 | 5.1 | 2.9 | 3.6 | 2.0 | -4.0 | -8.1 | -0.1 | -0.6 | -4.1 | -0.4 | 4.2 | 3.3 | 1.7 | -3.3 | -5.5 | 2.0 | -5.0 | -5.0 | -5.0 | -8.0 | -5.9 |
FACT-C= Functional Assessment of Chronic Illness Therapy (FACIT), which assessed HRQoL of cancer participants & participants with other chronic illnesses. It consists of total 36 items (27 items of general version of FACT-C and disease-specific subscale containing 9 CRC-specific items), summarized to 5 subscales: physical well-being (7 items), functional well-being (7 items), social/family well-being (7 items); all 3 subscales range:0-28, emotional well-being (6 items) range: 0-24, colorectal cancer subscale (9 items) range: 0-36; higher subscale score= better QoL. All single-item measures range: 0= 'Not at all' to 4= 'Very much'. Table summarizes functional well-being subscale, individual questions are linearly scaled & combined to form functional well-being subscale score (range 0-28). High score represents better QoL. (NCT02928224)
Timeframe: Baseline,Cycle (C)1 Day (D)1, C2 D1, C3 D1, C4 D1, C5 D1, C6 D1, C7 D1, C8 D1, C9 D1, C10 D1, C11 D1, C12 D1, C13 D1, C14 D1, C15 D1, C16 D1, C17 D1, C18 D1, C19 D1, C20 D1, C21 D1, C22 D1, C23 D1, End of Treatment, 30 Day Follow Up(each cycle of 28 days)
| Intervention | Units on a scale (Mean) | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | Change at Cycle 1 Day 1 | Change at Cycle 2 Day 1 | Change at Cycle 3 Day 1 | Change at Cycle 4 Day 1 | Change at Cycle 5 Day 1 | Change at Cycle 6 Day 1 | Change at Cycle 7 Day 1 | Change at Cycle 8 Day 1 | Change at Cycle 9 Day 1 | Change at Cycle 10 Day 1 | Change at Cycle 11 Day 1 | Change at Cycle 12 Day 1 | Change at Cycle 13 Day 1 | Change at End of Treatment | Change at 30 Day Follow Up | |
| Phase 3:Control Arm | 16.8 | -1.4 | -0.9 | -0.7 | -1.8 | -1.6 | -1.9 | -0.5 | -2.1 | -2.6 | 0.5 | -4.5 | -4.5 | -8.0 | -3.1 | -4.2 |
FACT-C= Functional Assessment of Chronic Illness Therapy (FACIT), which assessed HRQoL of cancer participants & participants with other chronic illnesses. It consists of total 36 items (27 items of general version of FACT-C and disease-specific subscale containing 9 CRC-specific items), summarized to 5 subscales: physical well-being (7 items), functional well-being (7 items), social/family well-being (7 items); all 3 subscales range:0-28, emotional well-being (6 items) range: 0-24, colorectal cancer subscale (9 items) range: 0-36; higher subscale score= better QoL. All single-item measures range: 0= 'Not at all' to 4= 'Very much'. Table summarizes functional well-being subscale, individual questions are linearly scaled & combined to form functional well-being subscale score (range 0-28). High score represents better QoL. (NCT02928224)
Timeframe: Baseline,Cycle (C)1 Day (D)1, C2 D1, C3 D1, C4 D1, C5 D1, C6 D1, C7 D1, C8 D1, C9 D1, C10 D1, C11 D1, C12 D1, C13 D1, C14 D1, C15 D1, C16 D1, C17 D1, C18 D1, C19 D1, C20 D1, C21 D1, C22 D1, C23 D1, End of Treatment, 30 Day Follow Up(each cycle of 28 days)
| Intervention | Units on a scale (Mean) | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | Change at Cycle 1 Day 1 | Change at Cycle 2 Day 1 | Change at Cycle 3 Day 1 | Change at Cycle 4 Day 1 | Change at Cycle 5 Day 1 | Change at Cycle 6 Day 1 | Change at Cycle 7 Day 1 | Change at Cycle 8 Day 1 | Change at Cycle 9 Day 1 | Change at Cycle 10 Day 1 | Change at Cycle 11 Day 1 | Change at Cycle 12 Day 1 | Change at Cycle 13 Day 1 | Change at Cycle 14 Day 1 | Change at Cycle 15 Day 1 | Change at Cycle 16 Day 1 | Change at Cycle 17 Day 1 | Change at Cycle 18 Day 1 | Change at Cycle 19 Day 1 | Change at Cycle 20 Day 1 | Change at Cycle 21 Day 1 | Change at End of Treatment | Change at 30 Day Follow Up | |
| Phase 3: Triplet Arm | 16.3 | -0.2 | -0.3 | -0.2 | 0.4 | 0.7 | 0.7 | 0.5 | 0.9 | -1.9 | -1.7 | -1.5 | -1.5 | -2.0 | -2.4 | -2.3 | -4.2 | -6.7 | -5.0 | -7.0 | -6.0 | -9.0 | -2.4 | -3.5 |
FACT-C= Functional Assessment of Chronic Illness Therapy (FACIT), which assessed HRQoL of cancer participants & participants with other chronic illnesses. It consists of total 36 items (27 items of general version of FACT-C and disease-specific subscale containing 9 CRC-specific items), summarized to 5 subscales: physical well-being (7 items), functional well-being (7 items), social/family well-being (7 items); all 3 subscales range:0-28, emotional well-being (6 items) range: 0-24, colorectal cancer subscale (9 items) range: 0-36; higher subscale score= better QoL. All single-item measures range: 0= 'Not at all' to 4= 'Very much'. Table summarizes functional well-being subscale, individual questions are linearly scaled & combined to form functional well-being subscale score (range 0-28). High score represents better QoL. (NCT02928224)
Timeframe: Baseline,Cycle (C)1 Day (D)1, C2 D1, C3 D1, C4 D1, C5 D1, C6 D1, C7 D1, C8 D1, C9 D1, C10 D1, C11 D1, C12 D1, C13 D1, C14 D1, C15 D1, C16 D1, C17 D1, C18 D1, C19 D1, C20 D1, C21 D1, C22 D1, C23 D1, End of Treatment, 30 Day Follow Up(each cycle of 28 days)
| Intervention | Units on a scale (Mean) | |||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | Change at Cycle 1 Day 1 | Change at Cycle 2 Day 1 | Change at Cycle 3 Day 1 | Change at Cycle 4 Day 1 | Change at Cycle 5 Day 1 | Change at Cycle 6 Day 1 | Change at Cycle 7 Day 1 | Change at Cycle 8 Day 1 | Change at Cycle 9 Day 1 | Change at Cycle 10 Day 1 | Change at Cycle 11 Day 1 | Change at Cycle 12 Day 1 | Change at Cycle 13 Day 1 | Change at Cycle 14 Day 1 | Change at Cycle 15 Day 1 | Change at Cycle 16 Day 1 | Change at Cycle 17 Day 1 | Change at Cycle 18 Day 1 | Change at Cycle 19 Day 1 | Change at Cycle 20 Day 1 | Change at Cycle 21 Day 1 | Change at Cycle 22 Day 1 | Change at Cycle 23 Day 1 | Change at End of Treatment | Change at 30 Day Follow Up | |
| Phase 3:Doublet Arm | 16.2 | -0.9 | -0.6 | -0.2 | -0.1 | -0.2 | 0.6 | -0.1 | 0.2 | -0.8 | -1.3 | -0.5 | -1.1 | -3.2 | -4.0 | -1.5 | -0.7 | -0.7 | -3.0 | -6.0 | -5.0 | -5.0 | -12.0 | -9.0 | -2.2 | -0.8 |
"The PGIC is a measure of participant's perceptions of change in their symptoms over time that can be used as an anchoring method to determine the minimal clinically important difference for other participant reported outcome (PROs). For this assessment, participants answered the following question: Since starting treatment, my colorectal cancer symptoms are: (1) very much improved, (2) much improved, (3) minimally improved, (4) no change, (5) minimally worse, (6) much worse or (7) very much worse." (NCT02928224)
Timeframe: Baseline,Cycle (C)1 Day (D)1, C2 D1, C3 D1, C4 D1, C5 D1, C6 D1, C7 D1, C8 D1, C9 D1, C10 D1, C11 D1, C12 D1, C13 D1, C14 D1, C15 D1, C16 D1, C17 D1, C18 D1, C19 D1, C20 D1, C21 D1, C22 D1, C23 D1, End of Treatment, 30 Day Follow Up(each cycle of 28 days)
| Intervention | Units on a scale (Mean) | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | Change at Cycle 1 Day 1 | Change at Cycle 2 Day 1 | Change at Cycle 3 Day 1 | Change at Cycle 4 Day 1 | Change at Cycle 5 Day 1 | Change at Cycle 6 Day 1 | Change at Cycle 7 Day 1 | Change at Cycle 8 Day 1 | Change at Cycle 9 Day 1 | Change at Cycle 10 Day 1 | Change at Cycle 11 Day 1 | Change at Cycle 12 Day 1 | Change at Cycle 13 Day 1 | Change at End of Treatment | Change at 30 Day Follow Up | |
| Phase 3:Control Arm | 3.9 | 0.0 | -0.3 | -0.5 | -0.5 | -0.7 | -0.8 | -1.1 | -1.0 | -1.0 | -0.3 | 0.0 | -0.5 | -1.0 | 0.4 | 0.7 |
"The PGIC is a measure of participant's perceptions of change in their symptoms over time that can be used as an anchoring method to determine the minimal clinically important difference for other participant reported outcome (PROs). For this assessment, participants answered the following question: Since starting treatment, my colorectal cancer symptoms are: (1) very much improved, (2) much improved, (3) minimally improved, (4) no change, (5) minimally worse, (6) much worse or (7) very much worse." (NCT02928224)
Timeframe: Baseline,Cycle (C)1 Day (D)1, C2 D1, C3 D1, C4 D1, C5 D1, C6 D1, C7 D1, C8 D1, C9 D1, C10 D1, C11 D1, C12 D1, C13 D1, C14 D1, C15 D1, C16 D1, C17 D1, C18 D1, C19 D1, C20 D1, C21 D1, C22 D1, C23 D1, End of Treatment, 30 Day Follow Up(each cycle of 28 days)
| Intervention | Units on a scale (Mean) | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | Change at Cycle 1 Day 1 | Change at Cycle 2 Day 1 | Change at Cycle 3 Day 1 | Change at Cycle 4 Day 1 | Change at Cycle 5 Day 1 | Change at Cycle 6 Day 1 | Change at Cycle 7 Day 1 | Change at Cycle 8 Day 1 | Change at Cycle 9 Day 1 | Change at Cycle 10 Day 1 | Change at Cycle 11 Day 1 | Change at Cycle 12 Day 1 | Change at Cycle 13 Day 1 | Change at Cycle 14 Day 1 | Change at Cycle 15 Day 1 | Change at Cycle 16 Day 1 | Change at Cycle 17 Day 1 | Change at Cycle 18 Day 1 | Change at Cycle 19 Day 1 | Change at Cycle 20 Day 1 | Change at Cycle 21 Day 1 | Change at End of Treatment | Change at 30 Day Follow Up | |
| Phase 3: Triplet Arm | 3.8 | -0.1 | -0.7 | -0.9 | -0.9 | -0.9 | -0.8 | -1.1 | -1.2 | -0.8 | -0.5 | -0.9 | -0.9 | -1.3 | -1.1 | -1.2 | -2.0 | -1.3 | -2.0 | -3.0 | -3.0 | -3.0 | 0.3 | -0.1 |
"The PGIC is a measure of participant's perceptions of change in their symptoms over time that can be used as an anchoring method to determine the minimal clinically important difference for other participant reported outcome (PROs). For this assessment, participants answered the following question: Since starting treatment, my colorectal cancer symptoms are: (1) very much improved, (2) much improved, (3) minimally improved, (4) no change, (5) minimally worse, (6) much worse or (7) very much worse." (NCT02928224)
Timeframe: Baseline,Cycle (C)1 Day (D)1, C2 D1, C3 D1, C4 D1, C5 D1, C6 D1, C7 D1, C8 D1, C9 D1, C10 D1, C11 D1, C12 D1, C13 D1, C14 D1, C15 D1, C16 D1, C17 D1, C18 D1, C19 D1, C20 D1, C21 D1, C22 D1, C23 D1, End of Treatment, 30 Day Follow Up(each cycle of 28 days)
| Intervention | Units on a scale (Mean) | |||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | Change at Cycle 1 Day 1 | Change at Cycle 2 Day 1 | Change at Cycle 3 Day 1 | Change at Cycle 4 Day 1 | Change at Cycle 5 Day 1 | Change at Cycle 6 Day 1 | Change at Cycle 7 Day 1 | Change at Cycle 8 Day 1 | Change at Cycle 9 Day 1 | Change at Cycle 10 Day 1 | Change at Cycle 11 Day 1 | Change at Cycle 12 Day 1 | Change at Cycle 13 Day 1 | Change at Cycle 14 Day 1 | Change at Cycle 15 Day 1 | Change at Cycle 16 Day 1 | Change at Cycle 17 Day 1 | Change at Cycle 18 Day 1 | Change at Cycle 19 Day 1 | Change at Cycle 20 Day 1 | Change at Cycle 21 Day 1 | Change at Cycle 22 Day 1 | Change at Cycle 23 Day 1 | Change at End of Treatment | Change at 30 Day Follow Up | |
| Phase 3:Doublet Arm | 3.8 | 0.1 | -0.8 | -1.2 | -1.1 | -1.1 | -1.2 | -1.0 | -1.1 | -0.9 | -0.6 | -1.1 | -0.8 | -0.9 | -1.5 | -1.6 | -0.7 | -1.0 | -1.0 | -0.5 | -2.0 | -2.0 | -2.0 | -2.0 | 0.1 | 0.5 |
(NCT02928224)
Timeframe: Predose and 1, 2, 4 and 6 hours post-dose on Day 1 of Cycles 1 and 2 (each cycle of 28 days)
| Intervention | Nanogram/milliliter *hour (Geometric Mean) | |
|---|---|---|
| Cycle 1 | Cycle 2 | |
| Combined Safety Lead-in | 1960 | 1540 |
(NCT02928224)
Timeframe: Predose and 1, 2, 4 and 6 hours post-dose on Day 1 of Cycles 1 and 2 (each cycle of 28 days)
| Intervention | Nanogram/milliliter *hour (Geometric Mean) | |
|---|---|---|
| Cycle 1 | Cycle 2 | |
| Combined Safety Lead-in | 841000 | 970000 |
(NCT02928224)
Timeframe: Predose and 1, 2, 4 and 6 hours post-dose on Day 1 of Cycles 1 and 2 (each cycle of 28 days)
| Intervention | Nanogram/milliliter *hour (Geometric Mean) | |
|---|---|---|
| Cycle 1 | Cycle 2 | |
| Combined Safety Lead-in | 11300 | 6660 |
(NCT02928224)
Timeframe: Predose and 1, 2, 4 and 6 hours post-dose on Day 1 of Cycles 1 and 2 (each cycle of 28 days)
| Intervention | Nanogram/milliliter *hour (Geometric Mean) | |
|---|---|---|
| Cycle 1 | Cycle 2 | |
| Combined Safety Lead-in | 206 | 70.0 |
(NCT02928224)
Timeframe: Predose and 1, 2, 4 and 6 hours post-dose on Day 1 of Cycles 1 and 2 (each cycle of 28 days)
| Intervention | Nanogram/milliliter (Geometric Mean) | |
|---|---|---|
| Cycle 1 | Cycle 2 | |
| Combined Safety Lead-in | 654 | 524 |
(NCT02928224)
Timeframe: Predose and 1, 2, 4 and 6 hours post-dose on Day 1 of Cycles 1 and 2 (each cycle of 28 days)
| Intervention | Nanogram/milliliter (Geometric Mean) | |
|---|---|---|
| Cycle 1 | Cycle 2 | |
| Combined Safety Lead-in | 195000 | 199000 |
(NCT02928224)
Timeframe: Predose and 1, 2, 4 and 6 hours post-dose on Day 1 of Cycles 1 and 2 (each cycle of 28 days)
| Intervention | Nanogram/milliliter (Geometric Mean) | |
|---|---|---|
| Cycle 1 | Cycle 2 | |
| Combined Safety Lead-in | 3360 | 2490 |
(NCT02928224)
Timeframe: Predose and 1, 2, 4 and 6 hours post-dose on Day 1 of Cycles 1 and 2 (each cycle of 28 days)
| Intervention | Nanogram/milliliter (Geometric Mean) | |
|---|---|---|
| Cycle 1 | Cycle 2 | |
| Combined Safety Lead-in | 59.9 | 20.5 |
(NCT02928224)
Timeframe: Predose and 1, 2, 4 and 6 hours post-dose on Day 1 of Cycles 1 and 2 (each cycle of 28 days)
| Intervention | Hours (Median) | |
|---|---|---|
| Cycle 1 | Cycle 2 | |
| Combined Safety Lead-in | 1.98 | 1.04 |
(NCT02928224)
Timeframe: Predose and 1, 2, 4 and 6 hours post-dose on Day 1 of Cycles 1 and 2 (each cycle of 28 days)
| Intervention | Hours (Median) | |
|---|---|---|
| Cycle 1 | Cycle 2 | |
| Combined Safety Lead-in | 3.77 | 3.05 |
(NCT02928224)
Timeframe: Predose and 1, 2, 4 and 6 hours post-dose on Day 1 of Cycles 1 and 2 (each cycle of 28 days)
| Intervention | Hours (Median) | |
|---|---|---|
| Cycle 1 | Cycle 2 | |
| Combined Safety Lead-in | 2.00 | 2.00 |
(NCT02928224)
Timeframe: Predose and 1, 2, 4 and 6 hours post-dose on Day 1 of Cycles 1 and 2 (each cycle of 28 days)
| Intervention | Hours (Median) | |
|---|---|---|
| Cycle 1 | Cycle 2 | |
| Combined Safety Lead-in | 2.00 | 1.58 |
An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Number of participants according to incidence of dose interruptions, dose modifications and dose discontinuations due to AEs were reported in this outcome measure. (NCT02928224)
Timeframe: From start of study treatment until 30 days post last dose of study treatment (maximum treatment exposure of 280 weeks)
| Intervention | Participants (Count of Participants) | ||
|---|---|---|---|
| Dose interruptions | Dose modifications | Discontinuation due to AEs | |
| Combined Safety Lead-in | 30 | 16 | 8 |
Clinically notable shifts was defined as worsening by at least 2 grades or to more than or equal to (>=) Grade 3 based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 where Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: life threatening and Grade 5: death. (NCT02928224)
Timeframe: From start of study treatment until 30 days post last dose of study treatment (for triplet arm: maximum treatment exposure of 277.4 weeks; for doublet arm: maximum treatment exposure of 268 weeks; for Control arm: maximum treatment exposure of 108 weeks)
| Intervention | Participants (Count of Participants) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Activated Partial Thromboplastin Time - Hyper | Hemoglobin - Hyper | Hemoglobin - Hypo | Leukocytes - Hyper | Leukocytes - Hypo | Lymphocytes - Hyper | Lymphocytes - Hypo | Neutrophils - Hypo | Platelets - Hypo | Prothrombin Intl. Normalized Ratio - Hyper | |
| Phase 3: Doublet Arm | 9 | 0 | 30 | 0 | 9 | 3 | 47 | 8 | 5 | 2 |
| Phase 3: Triplet Arm | 9 | 0 | 97 | 0 | 2 | 12 | 25 | 4 | 1 | 3 |
| Phase 3:Control Arm | 4 | 0 | 17 | 0 | 51 | 4 | 57 | 65 | 4 | 2 |
Clinically notable shifts was defined as worsening by at least 2 grades or to >= Grade 3 based on CTCAE version 4.03 where Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: life threatening and Grade 5: death. (NCT02928224)
Timeframe: From start of study treatment until 30 days post last dose of study treatment (for triplet arm: maximum treatment exposure of 277.4 weeks; for doublet arm: maximum treatment exposure of 268 weeks; for Control arm: maximum treatment exposure of 108 weeks)
| Intervention | Participants (Count of Participants) | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Alanine Aminotransferase - Hyper | Albumin - Hypo | Alkaline Phosphatase - Hyper | Aspartate Aminotransferase - Hyper | Bilirubin - Hyper | Calcium - Hyper | Calcium - Hypo | Creatine Kinase - Hyper | Creatinine - Hyper | Glucose - Hyper | Glucose - Hypo | Magnesium - Hyper | Magnesium - Hypo | Potassium - Hyper | Potassium - Hypo | Sodium - Hyper | Sodium - Hypo | Troponin I - Hyper | Urate - Hyper | |
| Phase 3: Control Arm | 10 | 17 | 18 | 9 | 12 | 0 | 7 | 3 | 6 | 4 | 1 | 2 | 9 | 5 | 9 | 2 | 5 | 0 | 1 |
| Phase 3: Doublet Arm | 7 | 16 | 12 | 7 | 13 | 0 | 8 | 1 | 11 | 16 | 0 | 1 | 4 | 10 | 7 | 1 | 4 | 0 | 2 |
| Phase 3: Triplet Arm | 11 | 50 | 13 | 11 | 11 | 1 | 15 | 18 | 45 | 8 | 4 | 0 | 11 | 14 | 5 | 1 | 10 | 0 | 4 |
Newly occurring clinically notable changes was defined as participants not meeting the criterion at baseline and meeting criterion post-baseline. The criterion included: heart rate- decrease from baseline > 25% and to a value < 50 and increase from baseline > 25% and to a value > 100. QT interval- new > 450 (millisecond) msec, new > 480 msec, new > 500 msec, increase from baseline > 30 msec and increase from baseline > 60 msec. QTcF- new > 450 msec, new > 480 msec, new > 500 msec, increase from baseline > 30 msec and increase from baseline > 60 msec. (NCT02928224)
Timeframe: From start of study treatment until 30 days post last dose of study treatment (for triplet arm: maximum treatment exposure of 277.4 weeks; for doublet arm: maximum treatment exposure of 268 weeks; for Control arm: maximum treatment exposure of 108 weeks)
| Intervention | Participants (Count of Participants) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Heart Rate - Decrease from baseline > 25% and to a value < 50 | Heart Rate - Increase from baseline > 25% and to a value > 100 | QT Interval - New > 450 millisecond (msec) | QT Interval - New > 480 msec | QT Interval - New > 500 msec | QT Interval - increase from baseline > 30 msec | QT Interval - increase from baseline > 60 msec | QTcF - New > 450 msec | QTcF - New > 480 msec | QTcF - New > 500 msec | QTcF - increase from baseline > 30 msec | QTcF - increase from baseline > 60 msec | |
| Phase 3: Control Arm | 0 | 28 | 7 | 2 | 0 | 32 | 10 | 23 | 5 | 2 | 24 | 5 |
| Phase 3: Doublet Arm | 4 | 24 | 30 | 7 | 5 | 99 | 21 | 51 | 18 | 6 | 75 | 20 |
| Phase 3: Triplet Arm | 1 | 27 | 17 | 4 | 3 | 97 | 22 | 39 | 9 | 1 | 59 | 12 |
Newly occurring clinically notable changes was defined as participants not meeting the criterion at baseline and meeting criterion post-baseline. The criterion included: low/high systolic blood pressure (SBP): <= 90 millimeters of mercury (mmHg) with decrease from baseline of >= 20mmHg or >= 160mmHg with increase from baseline of >= 20mmHg, low or high diastolic blood pressure (DBP): <= 50mmHg with decrease from baseline of >= 15mmHg or >= 100mmHg with increase from baseline of >= 15mmHg, low or high pulse: <= 50 beats/min with decrease from baseline of >= 15 beats/min or >= 120 beats/min with increase from baseline of >= 15 beats/min, low or high temperature: <= 36 degree Celsius (deg C) or >= 37.5 deg C. (NCT02928224)
Timeframe: From start of study treatment until 30 days post last dose of study treatment (for triplet arm: maximum treatment exposure of 277.4 weeks; for doublet arm: maximum treatment exposure of 268 weeks; for Control arm: maximum treatment exposure of 108 weeks)
| Intervention | Participants (Count of Participants) | |||||||
|---|---|---|---|---|---|---|---|---|
| Diastolic Blood Pressure - High | Diastolic Blood Pressure - Low | Pulse Rate - High | Pulse Rate - Low | Systolic Blood Pressure - High | Systolic Blood Pressure - Low | Temperature - High | Temperature - Low | |
| Phase 3: Control Arm | 7 | 5 | 20 | 3 | 5 | 10 | 25 | 55 |
| Phase 3: Doublet Arm | 6 | 27 | 14 | 4 | 13 | 28 | 23 | 84 |
| Phase 3: Triplet Arm | 8 | 21 | 23 | 3 | 19 | 37 | 33 | 93 |
Visual acuity was measured using the Snellen visual acuity conversion chart. This was determined by establishing the smallest optotypes that could be identified correctly by the participant at a given observation distance. Snellen visual acuity was reported as a Snellen fraction (m/M) in which the numerator (m) indicated the test distance and the denominator (M) indicated the distance at which the gap of the equivalent Landolt ring subtends 1 minute of arc. The LogMAR score was calculated as - log(m/M). The maximum increase in score of <= 0, 0 to < 0.1, 0.1 to < 0.2, 0.2 to < 0.3 and >=0.3 relative to baseline in LogMAR were reported in this endpoint. (NCT02928224)
Timeframe: From start of study treatment until 30 days post last dose of study treatment (for triplet arm: maximum treatment exposure of 277.4 weeks; for doublet arm: maximum treatment exposure of 268 weeks; for Control arm: maximum treatment exposure of 108 weeks)
| Intervention | Participants (Count of Participants) | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline <=0 to >0-<0.1 | Baseline <=0 to 0.1-<0.2 | Baseline <=0 to 0.2-<0.3 | Baseline <=0 to >=0.3 | Baseline <=0 to missing score | Baseline >0-<0.1 to <=0 | Baseline >0-<0.1 to 0.1-<0.2 | Baseline >0-<0.1 to 0.2-<0.3 | Baseline >0-<0.1 to >=0.3 | Baseline >0-<0.1 to missing score | Baseline 0.1-<0.2 to <=0 | Baseline 0.1-<0.2 to >0-<0.1 | Baseline 0.2-<0.3 to <=0 | Baseline 0.2-<0.3 to >0-<0.1 | Baseline 0.2-<0.3 to 0.1-<0.2 | Baseline 0.2-<0.3 to missing score | Baseline >=0.3 to <=0 | Baseline >=0.3 to >0-<0.1 | Baseline >=0.3 to 0.1-<0.2 | Baseline >=0.3 to 0.2-<0.3 | Baseline >=0.3 to missing score | Baseline 0.1-<0.2 to 0.2-<0.3 | Baseline 0.1-<0.2 to missing score | |
| Phase 3: Control Arm | 0 | 0 | 0 | 0 | 129 | 0 | 0 | 0 | 0 | 30 | 0 | 0 | 0 | 0 | 0 | 5 | 0 | 0 | 0 | 0 | 13 | 0 | 7 |
| Phase 3: Doublet Arm | 8 | 3 | 0 | 1 | 86 | 6 | 2 | 1 | 0 | 25 | 1 | 0 | 0 | 0 | 1 | 4 | 2 | 0 | 1 | 0 | 19 | 3 | 9 |
| Phase 3: Triplet Arm | 33 | 15 | 4 | 6 | 9 | 17 | 7 | 4 | 3 | 3 | 5 | 1 | 1 | 3 | 3 | 1 | 9 | 4 | 1 | 2 | 1 | 0 | 0 |
Left ventricular ejection fraction (LVEF) abnormalities were defined according to CTCAE version 4.03 where Grade 0: Non-missing value below Grade 2, Grade 2: LVEF between 40% and 50% or absolute change from baseline between -10% and < -20%, Grade 3: LVEF between 20% and 39% or absolute change from baseline <= -20%, Grade 4: LVEF lower than 20%. Categories with at least 1 non-zero data values showing any shift in Grade from baseline to 1 day after dose 1 (post-baseline) were reported. Participants whose grade category was unchanged (e.g. Grade 0 to Grade 0) were not reported. (NCT02928224)
Timeframe: From start of study treatment until 30 days post last dose of study treatment (for triplet arm: maximum treatment exposure of 277.4 weeks; for doublet arm: maximum treatment exposure of 268 weeks; for Control arm: maximum treatment exposure of 108 weeks)
| Intervention | Participants (Count of Participants) | ||||
|---|---|---|---|---|---|
| Baseline Grade 0 to Grade 2 post baseline | Baseline Grade 0 to Grade 3 post baseline | Baseline Grade 0 to missing grade | Baseline Grade 2 to missing grade | Baseline missing grade to Grade 0 post baseline | |
| Phase 3: Control Arm | 0 | 0 | 186 | 2 | 0 |
| Phase 3: Doublet Arm | 0 | 1 | 205 | 3 | 0 |
| Phase 3: Triplet Arm | 27 | 1 | 17 | 0 | 1 |
8 reviews available for carbamates and Colorectal Neoplasms
| Article | Year |
|---|---|
Management of adverse events from the treatment of encorafenib plus cetuximab for patients with BRAF V600E-mutant metastatic colorectal cancer: insights from the BEACON CRC study.
Topics: Antineoplastic Combined Chemotherapy Protocols; Carbamates; Cetuximab; Colorectal Neoplasms; Humans; | 2021 |
Hsp70 inhibitors: Implications for the treatment of colorectal cancer.
Topics: Antineoplastic Agents; Biological Products; Carbamates; Colorectal Neoplasms; Endoplasmic Reticulum | 2019 |
Binimetinib, encorafenib and cetuximab (BEACON Trial) combination therapy for patients with BRAF V600E-mutant metastatic colorectal cancer.
Topics: Benzimidazoles; Carbamates; Cetuximab; Clinical Trials, Phase III as Topic; Colorectal Neoplasms; Dr | 2019 |
Current perspectives on the treatment of BRAF mutated colorectal carcinoma.
Topics: Antineoplastic Combined Chemotherapy Protocols; Carbamates; Cetuximab; Colorectal Neoplasms; Humans; | 2020 |
The EMA assessment of encorafenib in combination with cetuximab for the treatment of adult patients with metastatic colorectal carcinoma harbouring the BRAFV600E mutation who have received prior therapy.
Topics: Adult; Antineoplastic Combined Chemotherapy Protocols; Benzimidazoles; Carbamates; Cetuximab; Clinic | 2021 |
Encorafenib (Braftovi) for metastatic colorectal cancer.
Topics: Antineoplastic Combined Chemotherapy Protocols; Carbamates; Cetuximab; Clinical Trials as Topic; Col | 2021 |
Encorafenib: A Review in Metastatic Colorectal Cancer with a BRAF V600E Mutation.
Topics: Antineoplastic Combined Chemotherapy Protocols; Carbamates; Cetuximab; Colorectal Neoplasms; Drug In | 2021 |
The therapeutic potential of targeting the BRAF mutation in patients with colorectal cancer.
Topics: Amino Acid Substitution; Antineoplastic Combined Chemotherapy Protocols; Carbamates; Cinnamates; Col | 2018 |
8 trials available for carbamates and Colorectal Neoplasms
| Article | Year |
|---|---|
Quality of life with encorafenib plus cetuximab with or without binimetinib treatment in patients with BRAF V600E-mutant metastatic colorectal cancer: patient-reported outcomes from BEACON CRC.
Topics: Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Benzimidazoles; Carbamates; C | 2022 |
Encorafenib plus cetuximab with or without binimetinib in patients with BRAF V600E-mutated metastatic colorectal cancer: real-life data from an Italian multicenter experience.
Topics: Antineoplastic Combined Chemotherapy Protocols; Benzimidazoles; Carbamates; Cetuximab; Colonic Neopl | 2022 |
Encorafenib, Binimetinib, and Cetuximab in
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Benzimidazoles; Carb | 2019 |
Encorafenib, Binimetinib, and Cetuximab in
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Benzimidazoles; Carb | 2019 |
Encorafenib, Binimetinib, and Cetuximab in
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Benzimidazoles; Carb | 2019 |
Encorafenib, Binimetinib, and Cetuximab in
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Benzimidazoles; Carb | 2019 |
Encorafenib Plus Cetuximab as a New Standard of Care for Previously Treated
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Carbamates; Cetuxima | 2021 |
A Phase Ib Dose-Escalation Study of Encorafenib and Cetuximab with or without Alpelisib in Metastatic
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocol | 2017 |
Binimetinib, Encorafenib, and Cetuximab Triplet Therapy for Patients With
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Benzimidazoles; Carbamates; Cetuximab; | 2019 |
Phase II trial of intravenous CI-980 (NSC 370147) in patients with metastatic colorectal carcinoma. Model for prospective evaluation of neurotoxicity.
Topics: Adenocarcinoma; Adult; Aged; Antineoplastic Agents; Carbamates; Central Nervous System Diseases; Col | 1997 |
Neurotoxicity of CI-980, a novel mitotic inhibitor.
Topics: Adult; Aged; Antineoplastic Agents; Carbamates; Cognition; Cognition Disorders; Colorectal Neoplasms | 1997 |
31 other studies available for carbamates and Colorectal Neoplasms
| Article | Year |
|---|---|
Cost-effectiveness of encorafenib plus cetuximab in BRAF V600E-mutated colorectal cancer.
Topics: Antineoplastic Combined Chemotherapy Protocols; Carbamates; Cetuximab; Colorectal Neoplasms; Cost-Be | 2022 |
Conversion Therapy With Encorafenib and Cetuximab for Chemo-Refractory BRAF V600E-Mutated Liver-Limited Colorectal Cancer Metastasis: The First Case Report.
Topics: Carbamates; Cetuximab; Colorectal Neoplasms; Humans; Liver; Proto-Oncogene Proteins B-raf; Sulfonami | 2021 |
Bilateral Serous Retinal Detachment Associated with a Mitogen-activated Protein KinaseKinase Inhibitor in a Patient with BRAF-mutant Colorectal Cancer.
Topics: Aged; Carbamates; Colorectal Neoplasms; Female; Humans; Intercellular Signaling Peptides and Protein | 2022 |
Upfront progression under pembrolizumab followed by a complete response after encorafenib and cetuximab treatment in BRAF V600E-mutated and microsatellite unstable metastatic colorectal cancer patient: A case report.
Topics: Antibodies, Monoclonal, Humanized; Antineoplastic Agents; Carbamates; Cetuximab; Colon; Colorectal N | 2022 |
Rechallenge With BRAF and anti-EGFR Inhibitors in Patients With Metastatic Colorectal Cancer Harboring BRAF
Topics: Antineoplastic Combined Chemotherapy Protocols; Benzimidazoles; Carbamates; Cetuximab; Colorectal Ne | 2022 |
Multiple pigmented nevi induced by the combination of encorafenib and cetuximab in a colon cancer patient.
Topics: Antineoplastic Combined Chemotherapy Protocols; Carbamates; Cetuximab; Colonic Neoplasms; Colorectal | 2022 |
Encorafenib plus cetuximab treatment in BRAF V600E-mutated metastatic colorectal cancer patients pre-treated with an anti-EGFR: An AGEO-GONO case series.
Topics: Antineoplastic Combined Chemotherapy Protocols; Carbamates; Cetuximab; Colorectal Neoplasms; Humans; | 2022 |
Fewer cetuximab-related skin-toxicities in colorectal cancer patients treated with encorafenib: a Yin and Yang effect of ERK paradoxical activation.
Topics: Carbamates; Cetuximab; Colorectal Neoplasms; Humans; Proto-Oncogene Proteins B-raf; Sulfonamides | 2022 |
Overcoming acquired MET amplification after encorafenib-cetuximab in BRAF-V600E mutated colorectal cancer.
Topics: Antineoplastic Combined Chemotherapy Protocols; Carbamates; Cetuximab; Colorectal Neoplasms; Humans; | 2022 |
Retrospective Analysis of Treatment Pathways in Patients With BRAF
Topics: Antibodies, Monoclonal; Antineoplastic Combined Chemotherapy Protocols; Carbamates; Cetuximab; Color | 2022 |
BEACON of hope in BRAF
Topics: Benzimidazoles; Carbamates; Cetuximab; Colorectal Neoplasms; Humans; Proto-Oncogene Proteins B-raf; | 2019 |
Targeted therapy for BRAF-mutant colorectal cancer.
Topics: Antineoplastic Combined Chemotherapy Protocols; Benzimidazoles; Carbamates; Cetuximab; Clinical Tria | 2019 |
BET inhibitor bromosporine enhances 5-FU effect in colorectal cancer cells.
Topics: Animals; Antineoplastic Combined Chemotherapy Protocols; Apoptosis; Carbamates; Cell Cycle; Cell Cyc | 2020 |
Encorafenib, Binimetinib, and Cetuximab in BRAF V600E-Mutated Colorectal Cancer.
Topics: Benzimidazoles; Carbamates; Cetuximab; Colorectal Neoplasms; Humans; Proto-Oncogene Proteins B-raf; | 2020 |
Encorafenib, Binimetinib, and Cetuximab in BRAF V600E-Mutated Colorectal Cancer.
Topics: Benzimidazoles; Carbamates; Cetuximab; Colorectal Neoplasms; Humans; Proto-Oncogene Proteins B-raf; | 2020 |
Encorafenib, Binimetinib, and Cetuximab in BRAF V600E-Mutated Colorectal Cancer.
Topics: Benzimidazoles; Carbamates; Cetuximab; Colorectal Neoplasms; Humans; Proto-Oncogene Proteins B-raf; | 2020 |
Encorafenib, Binimetinib, and Cetuximab in BRAF V600E-Mutated Colorectal Cancer. Reply.
Topics: Benzimidazoles; Carbamates; Cetuximab; Colorectal Neoplasms; Humans; Proto-Oncogene Proteins B-raf; | 2020 |
[New drug approval: Encorafenib-metastatic colorectal cancers with BRAF V600E mutation after systemic chemotherapy].
Topics: Antineoplastic Combined Chemotherapy Protocols; Benzimidazoles; Carbamates; Cetuximab; Clinical Tria | 2020 |
Mutational profiles associated with resistance in patients with BRAFV600E mutant colorectal cancer treated with cetuximab and encorafenib +/- binimetinib or alpelisib.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Benzimidazoles; Biomarkers, Tumor; Carb | 2021 |
Evaluation of the Cost-effectiveness of Doublet Therapy in Metastatic BRAF Variant Colorectal Cancer.
Topics: Antineoplastic Combined Chemotherapy Protocols; Carbamates; Cetuximab; Colorectal Neoplasms; Cost-Be | 2021 |
Cost-Effectiveness Analysis of Encorafenib, Binimetinib, and Cetuximab in BRAF V600E-Mutated Metastatic Colorectal Cancer in the USA.
Topics: Antineoplastic Combined Chemotherapy Protocols; Benzimidazoles; Carbamates; Cetuximab; Colorectal Ne | 2021 |
Acute renal failure under encorafenib, binimetinib and cetuximab for BRAF V600E-mutated colorectal cancer.
Topics: Acute Kidney Injury; Antineoplastic Combined Chemotherapy Protocols; Benzimidazoles; Carbamates; Cet | 2021 |
The role of CB
Topics: Amidohydrolases; Arachidonic Acids; Benzamides; Benzodioxoles; Caco-2 Cells; Carbamates; Colorectal | 2017 |
Highly Sensitive Quantification Method for Amine Submetabolome Based on AQC-Labeled-LC-Tandem-MS and Multiple Statistical Data Mining: A Potential Cancer Screening Approach.
Topics: Amines; Aminoquinolines; Biomarkers, Tumor; Breast Neoplasms; Carbamates; Chromatography, High Press | 2018 |
Encorafenib inhibits migration, induces cell cycle arrest and apoptosis in colorectal cancer cells.
Topics: Apoptosis; Carbamates; Cell Cycle Checkpoints; Cell Line, Tumor; Cell Movement; Colorectal Neoplasms | 2019 |
Blood volatile compounds as biomarkers for colorectal cancer.
Topics: Adenocarcinoma; Aged; Alkadienes; Biomarkers, Tumor; Breath Tests; Carbamates; Case-Control Studies; | 2014 |
Drug combo beneficial in colorectal cancer.
Topics: Antibodies, Monoclonal, Humanized; Antineoplastic Combined Chemotherapy Protocols; Carbamates; Cetux | 2015 |
ERK-dependent phosphorylation of HSF1 mediates chemotherapeutic resistance to benzimidazole carbamates in colorectal cancer cells.
Topics: Antineoplastic Agents; Benzimidazoles; Carbamates; Cell Line, Tumor; Colorectal Neoplasms; DNA-Bindi | 2015 |
Discodermolide analogues as the chemical component of combination bacteriolytic therapy.
Topics: Alkanes; Animals; Antineoplastic Agents; Bacterial Toxins; Binding Sites; Carbamates; Colorectal Neo | 2005 |
High-resolution reversed-phase high-performance liquid chromatography analysis of polyamines and their monoacetyl conjugates by fluorescence detection after derivatization with N-hydroxysuccinimidyl 6-quinolinyl carbamate.
Topics: Acetylation; Aminoquinolines; Animals; Carbamates; Chromatography, High Pressure Liquid; Colorectal | 1997 |
Exploring the mechanisms of action of FB642 at the cellular level.
Topics: Animals; Antineoplastic Agents; Apoptosis; Benzimidazoles; Breast Neoplasms; Carbamates; Cell Cycle; | 2001 |