thymine and Neoplasm Metastasis

thymine has been researched along with Neoplasm Metastasis in 54 studies

Neoplasm Metastasis: The transfer of a neoplasm from one organ or part of the body to another remote from the primary site.

Research

Studies (54)

Authors

Clinical Trials (8)

Trial Overview

Trial Outcomes

Disease Control Rate (DCR) Based on irRC Criteria

DCR was defined as the percentage of participants with objective evidence of radiologic complete response (CR), partial response (PR), or stable disease (SD) and was based on the overall best response from each participant as determined from investigator response assessments and following irRC criteria. Per irRC criteria, CR was defined as the disappearance of all tumor lesions (measurable or not, and no new lesions). PR was defined as a decrease in the sum of the products of the two largest perpendicular diameters by 50% or greater by a consecutive assessment at least 4 weeks after first documentation. SD was defined as the failure to meet criteria for irCR or irPR in absence of in absence of irPD. (NCT02860546)
Timeframe: From first dose of study treatment up to 30 days after the last dose of study treatment (up to 53 weeks)

Disease Control Rate (DCR) Based on RECIST Criteria

DCR was defined as the percentage of participants with objective evidence of radiologic CR, PR, or SD and was based on the overall best response from each participant as determined from investigator response assessments and following RECIST Criteria version 1.1. Per RECIST Criteria CR defined as disappearance of all target lesions. Reduction in any pathological lymph nodes in short axis to <10 mm. PR defined as at least a 30% decrease in the sum of diameters of the target lesions, taking as a reference the baseline sum diameters. SD defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as a reference the smallest sum diameters during study. (NCT02860546)
Timeframe: From first dose of study treatment up to 30 days after the last dose of study treatment (up to 53 weeks)

Immune-Related Overall Response Rate (irORR)

irORR was defined as the percentage of participants achieving a complete response (irCR) or partial response (irPR) based on irRC criteria. Per irRC criteria, Complete Response (irCR) was defined as the disappearance of all tumor lesions (measurable or not, and no new lesions)., Partial Response (irPR) was defined as a decrease in the sum of the products of the two largest perpendicular diameters (SPD) by 50 percent (%) or greater by a consecutive assessment at least 4 weeks after first documentation, Stable Disease (irSD) was defined as the failure to meet criteria for irCR or irPR in absence of progressive disease (irPD), irPD was defined as at least 25% increase in SPD relative to nadir. (NCT02860546)
Timeframe: From first dose of study treatment up to 30 days after the last dose of study treatment (up to 53 weeks)

Number of Participants With Dose Limiting Toxicities (DLTs)

"DLT: defined as occurrence of any of the following-~Hematological toxicities:~Grade 4 neutropenia lasting greater than(>)7 days~Grade 4 febrile neutropenia and fever greater than or equal to (>=)38 degree celsius for over 1 hour~Grade 4 thrombocytopenia or grade 3 thrombocytopenia associated with bleeding or requiring transfusions~Non-hematological toxicities:~Grade 3 or grade 4 non-hematologic toxicity (excluding alopecia, nausea, vomiting, diarrhea)~Grade 3 or grade 4 nausea/vomiting lasting >48 hours and uncontrolled by aggressive anti-emetic therapy, including serotonin 5-HT3 receptor antagonists (e.g, ondansetron)~Grade 3 or grade 4 diarrhea lasting > 48 hours and unresponsive to antidiarrheal medication~Drug-related toxicities:~Any drug-related toxicity resulting in > 2 weeks delay in initiation of Cycle 2 (i.e, cannot start Cycle 2 until Day 43 or later)~Any drug-related toxicity that prevents completion of 80% compliance for either drug in Cycle 1" (NCT02860546)
Timeframe: Cycle 1 (each cycle is of 4 weeks)

Overall Response Rate (ORR)

ORR was defined as the percentage of participants with objective evidence of complete response (CR) or partial response (PR) per response evaluation criteria in solid tumors (RECIST) version 1.1.CR was defined as the disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to less than (<)10 millimeters (mm). PR was defined as at least a 30 % decrease in the sum of diameters of the target lesions, taking as a reference the baseline sum diameters. (NCT02860546)
Timeframe: From first dose of study treatment up to 30 days after the last dose of study treatment (up to 53 weeks)

Recommended Phase 2 Dose (RP2D)

RP2D of TAS-102 was evaluated based on the safety and tolerability of the combination therapy of TAS-102 and Nivolumab. (NCT02860546)
Timeframe: Cycle 1 (each cycle is of 4 weeks)

Number of Participants With Grade 3 or Higher Laboratory Tests Abnormalities

Hematological and chemistry laboratory tests abnormalities were graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03. as: Grade 1 (Mild, asymptomatic or mild symptoms); Grade 2 (Moderate, minimal, local or noninvasive intervention indicated); Grade 3 (Severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated); Grade 4 (Life-threatening consequences, urgent intervention indicated); Grade 5 (Death related to AE). (NCT02860546)
Timeframe: From first dose of study treatment up to 30 days after the last dose of study treatment (up to 53 weeks)

Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)

An adverse event (AE) was defined as any untoward medical condition that occurs in a participants while participating in a clinical study and does not necessarily have a causal relationship with the use of the study treatment. A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. TEAEs: AEs that developed or worsened during the on-treatment period which was defined as the period from the time of first dose of study treatment until 30 days after the last dose of study treatment. (NCT02860546)
Timeframe: From first dose of study treatment up to 30 days after the last dose of study treatment (up to 53 weeks)

Progression-Free Survival (PFS) Based on Immune Related Response-Criteria (irRC)

Immune-related progression free survival was defined as the time (in months) from the date of first dose of study treatment until the date of the investigator-assessed radiological disease progression (based on irRC) or death due to any cause. Participants who were alive with no disease progression at the moment of the analysis cut-off date was censored at the date of the last tumor assessment. Per irRC criteria disease progression defined as at least 25% increase in SPD relative to nadir. Analysis was performed using Kaplan-Meier estimates. (NCT02860546)
Timeframe: From the first dose of study treatment to disease progression or death (up to 53 weeks)

Progression-Free Survival (PFS) Based on RECIST Criteria

Progression free survival was defined as the time (in months) from the date of first dose of study treatment until the date of the investigator-assessed radiological disease progression (based on RECIST 1.1) or death due to any cause. Per RECIST criteria disease progression defined as least 20% increase in the sum of diameters of the target lesions, taking as a reference the smallest sum on study, including the baseline sum. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Definitive new lesion presence also indicated progression. (NCT02860546)
Timeframe: From the first dose of study treatment to disease progression or death (up to 53 weeks)

Overall Survival

Overall survival was defined as the time from the date of randomization to the date of death for participants. If a participant discontinued study medication for reasons other than radiologic disease progression, the participant was followed for tumor response until radiologic disease progression or initiation of new anticancer therapy. (NCT01607957)
Timeframe: Every 8 weeks, up to 12 months after the last participant was randomized or until the target number of events (deaths) was met, whichever was later. (Overall survival data was collected till 24 Jan 2014 which was date of observation of the 571st death)

Progression-free Survival

Tumor assessments were performed throughout the study based on RECIST, Version 1.1, 2009. Progression free survival was defined as the time (in months) from the date of randomization until the date of the investigator-assessed radiological disease progression or death due to any cause. For participants who were alive with no radiological disease progression as of the analysis cut-off date, their survival was censored at the date of the last tumor assessment. Participants who received non-study cancer treatment before disease progression, or participants with clinical but not radiologic evidence of progression, were censored at the date of the last radiologic evaluable tumor assessment before the non-study cancer treatment was initiated. (NCT01607957)
Timeframe: Every 8 weeks, up to 12 months after the last participant was randomized or until the date of the investigator-assessed radiological disease progression or death due to any cause,whichever was later. (Progression free survival cutoff: 31 Jan 2014)

Percentage of Participants With Adverse Events (AE), Treatment-Related AEs, Discontinuations, Serious Adverse Events (SAEs) and Deaths

An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-related AEs were events between administration of study drug and up to 30 Days that were absent before treatment or that worsened relative to pre-treatment state. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability /incapacity; congenital anomaly. The AEs were graded for severity using National Cancer Institute Common Terminology Criteria for AEs. (NCT01607957)
Timeframe: From the time of signing the informed consent form until the period of participant follow up (30 days following after the administration of last dose of study medication or until initiation of new antitumor therapy, whichever was earlier

Reviews

10 reviews available for thymine and Neoplasm Metastasis

Trials

14 trials available for thymine and Neoplasm Metastasis

Other Studies

30 other studies available for thymine and Neoplasm Metastasis