pteridines has been researched along with Fatigue in 2 studies
Fatigue: The state of weariness following a period of exertion, mental or physical, characterized by a decreased capacity for work and reduced efficiency to respond to stimuli.
Excerpt | Relevance | Reference |
---|---|---|
"Volasertib is a potent, selective, cell cycle kinase inhibitor that induces mitotic arrest and apoptosis by targeting Polo-like kinase." | 2.80 | A Randomized, Open-Label Phase II Trial of Volasertib as Monotherapy and in Combination With Standard-Dose Pemetrexed Compared With Pemetrexed Monotherapy in Second-Line Treatment for Non-Small-Cell Lung Cancer. ( Blais, N; Chu, Q; Ellis, PM; Gu, Y; Hirsh, V; Leighl, NB; Liu, D; Pilz, K; Reaume, MN; Sadrolhefazi, B; Wierzbicki, R, 2015) |
"BI 2536 is a potent, highly selective inhibitor of polo-like kinase (Plk) 1." | 2.78 | A phase I open-label dose-escalation study of intravenous BI 2536 together with pemetrexed in previously treated patients with non-small-cell lung cancer. ( Chu, QS; Ellis, PM; Fritsch, H; Gaschler-Markefski, B; Gyorffy, S; Laurie, SA; Leighl, N; Munzert, G, 2013) |
Timeframe | Studies, this research(%) | All Research% |
---|---|---|
pre-1990 | 0 (0.00) | 18.7374 |
1990's | 0 (0.00) | 18.2507 |
2000's | 0 (0.00) | 29.6817 |
2010's | 2 (100.00) | 24.3611 |
2020's | 0 (0.00) | 2.80 |
Authors | Studies |
---|---|
Ellis, PM | 2 |
Leighl, NB | 1 |
Hirsh, V | 1 |
Reaume, MN | 1 |
Blais, N | 1 |
Wierzbicki, R | 1 |
Sadrolhefazi, B | 1 |
Gu, Y | 1 |
Liu, D | 1 |
Pilz, K | 1 |
Chu, Q | 1 |
Chu, QS | 1 |
Leighl, N | 1 |
Laurie, SA | 1 |
Fritsch, H | 1 |
Gaschler-Markefski, B | 1 |
Gyorffy, S | 1 |
Munzert, G | 1 |
Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
---|---|---|---|---|---|---|---|
A Randomised Open-label Phase II Trial of BI 6727 Monotherapy and BI 6727 in Combination With Standard Dose Pemetrexed Compared to Pemetrexed Monotherapy in Second Line Non-small Cell Lung Cancer[NCT00824408] | Phase 2 | 143 participants (Actual) | Interventional | 2009-03-31 | Completed | ||
[information is prepared from clinicaltrials.gov, extracted Sep-2024] |
CL - total clearance of pemetrexed in plasma after IV administration (NCT00824408)
Timeframe: 5 minutes before pemetrexed infusion, at the end of the infusion and 1.5 hours (h), 2.5h, 4.5h and 25.5h after the end of pemetrexed infusion
Intervention | mL/min (Geometric Mean) |
---|---|
Volasertib 250 mg + Pemetrexed 500 mg/m2 | 54.4 |
Volasertib 300 mg + Pemetrexed 500 mg/m2 | 69.1 |
Cmax - maximum measured concentration of pemetrexed in plasma (NCT00824408)
Timeframe: 5 minutes before pemetrexed infusion, at the end of the infusion and 1.5 hours (h), 2.5h, 4.5h and 25.5h after the end of pemetrexed infusion
Intervention | ng/mL (Geometric Mean) |
---|---|
Volasertib 250 mg + Pemetrexed 500 mg/m2 | 131000 |
Volasertib 300 mg + Pemetrexed 500 mg/m2 | 115000 |
Cmax - maximum measured concentration of volasertib in plasma. (NCT00824408)
Timeframe: 5 minutes (min) before the start of Volasertib infusion and 1 hour (h), 2h, 4h, 24h, 168h and 336h after the start of Volasertib infusion
Intervention | ng/mL (Geometric Mean) |
---|---|
Volasertib 250 mg + Pemetrexed 500 mg/m2 | 554 |
Volasertib 300 mg + Pemetrexed 500 mg/m2 | 635 |
Volasertib 300 mg | 565 |
The duration of overall response was measured from the time measurement criteria were met for CR or PR (whichever was first recorded) until the first date that recurrent or progressive disease (PD) was objectively documented (taking as reference for PD the smallest measurements recorded since treatment began). The duration of overall CR was measured from the time measurement criteria were first met for CR until the first date that recurrent disease was objectively documented. Duration of disease control is presented here. (NCT00824408)
Timeframe: From the time measurement criteria were met for CR or PR (whichever was first recorded) until the first date that recurrent or progressive disease was objectively documented
Intervention | weeks (Median) |
---|---|
Randomization Phase: Volasertib 300 mg | 23.0 |
Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2 | 19.6 |
Randomization Phase: Pemetrexed 500 mg/m2 | 23.4 |
"Occurence of Dose-limiting toxicity (DLT). A DLT was defined as one or more of the following:~treatment-related CTCAE Grade 3 or 4 nonhematological toxicity (except emesis or diarrhea responding to supportive treatment).~treatment-related CTCAE Grade 4 neutropenia for ≥7 days and/or complicated by infection.~CTCAE Grade 4 thrombocytopenia." (NCT00824408)
Timeframe: Patients were treated for repeated 21-day treatment cycles until disease progression or intolerability of the trial drug, whichever occurred first.
Intervention | participants (Number) |
---|---|
Run-in Phase: Volasertib 250 mg + Pemetrexed 500 mg/m2 | 1 |
Run-in Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2 | 1 |
Overall survival (OS) was defined as the duration of time from randomization to time of death. (NCT00824408)
Timeframe: From randomization until time of death
Intervention | months (Median) |
---|---|
Randomization Phase: Volasertib 300 mg | 22.9 |
Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2 | 17.1 |
Randomization Phase: Pemetrexed 500 mg/m2 | 17.4 |
"Disease progression was defined according to the Response Evaluation Criteria in Solid Tumours (RECIST)) criteria. Progression-free survival time was calculated as the duration from the date of randomization to the date of disease progression or death, whichever occured first. For patients with known date of progression (or death): PFS [days] = min (date of progression, date of death) - date of randomization + 1 day. For patients without progression or death, PFS was censored at the last imaging date that showed no disease progression: PFS [days, censored] = date of last imaging showing no progression - date randomization + 1 day.~The number of participants analysed displays the number of patients with an event (progression)." (NCT00824408)
Timeframe: From randomization until disease progression or death
Intervention | months (Median) |
---|---|
Randomization Phase: Volasertib 300 mg | 1.4 |
Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2 | 3.3 |
Randomization Phase: Pemetrexed 500 mg/m2 | 5.3 |
CL - total clearance of volasertib in plasma after IV administration (NCT00824408)
Timeframe: 5 minutes (min) before the start of Volasertib infusion and 1 hour (h), 2h, 4h, 24h, 168h and 336h after the start of Volasertib infusion
Intervention | mL/min (Geometric Mean) |
---|---|
Volasertib 250 mg + Pemetrexed 500 mg/m2 | 782 |
Volasertib 300 mg + Pemetrexed 500 mg/m2 | 882 |
Volasertib 300 mg | 867 |
Vss - apparent volume of distribution at steady state following IV administration of pemetrexed (NCT00824408)
Timeframe: 5 minutes before pemetrexed infusion, at the end of the infusion and 1.5 hours (h), 2.5h, 4.5h and 25.5h after the end of pemetrexed infusion
Intervention | Litres (Geometric Mean) |
---|---|
Volasertib 250 mg + Pemetrexed 500 mg/m2 | 9.40 |
Volasertib 300 mg + Pemetrexed 500 mg/m2 | 13.1 |
Vss - apparent volume of distribution at steady state following IV administration of volasertib (NCT00824408)
Timeframe: 5 minutes (min) before the start of Volasertib infusion and 1 hour (h), 2h, 4h, 24h, 168h and 336h after the start of Volasertib infusion
Intervention | Litres (Geometric Mean) |
---|---|
Volasertib 250 mg + Pemetrexed 500 mg/m2 | 6730 |
Volasertib 300 mg + Pemetrexed 500 mg/m2 | 6750 |
Volasertib 300 mg | 6230 |
Frequency of patients with possible clinically significant abnormalities (NCT00824408)
Timeframe: From first drug infusion until 21 days after last drug infusion, up to 1100 days
Intervention | participants (Number) | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Haemoglobin - Low | White blood cell ct. - Low | White blood cell ct. - High | Platelets - Low | Platelets - High | Neutrophils - Low | Lymphocytes - Low | AST/GOT, SGOT - High | ALT/GPT, SGPT - High | Alkaline phosphatase - High | Creatinine - High | Bilirubin, total - High | |
Randomization Phase: Pemetrexed 500 mg/m2 | 14 | 12 | 1 | 2 | 3 | 12 | 22 | 3 | 6 | 5 | 0 | 1 |
Randomization Phase: Volasertib 300 mg | 16 | 15 | 1 | 8 | 3 | 13 | 16 | 0 | 0 | 0 | 0 | 1 |
Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2 | 21 | 25 | 0 | 3 | 0 | 23 | 22 | 6 | 10 | 0 | 3 | 1 |
Run-in Phase: Volasertib 250 mg + Pemetrexed 500 mg/m2 | 1 | 4 | 0 | 0 | 0 | 4 | 4 | 0 | 0 | 0 | 0 | 1 |
Run-in Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2 | 2 | 2 | 0 | 1 | 1 | 2 | 4 | 1 | 1 | 0 | 0 | 0 |
Objective tumor response, defined as complete response (CR), and partial response (PR), evaluated according to RECIST criteria. Evaluation of target lesions: Complete Response (CR): disappearance of all target lesions. Partial Response (PR): ≥30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. Evaluation of nontarget lesions: Complete Response (CR): disappearance of all nontarget lesions. (NCT00824408)
Timeframe: From first drug infusion until 21 days after last drug infusion, up to 1100 days
Intervention | percentage of participants (Number) | |
---|---|---|
Complete response (CR) | Partial response (PR) | |
Randomization Phase: Pemetrexed 500 mg/m2 | 0.0 | 10.6 |
Randomization Phase: Volasertib 300 mg | 0.0 | 8.1 |
Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2 | 0.0 | 21.3 |
Run-in Phase: Volasertib 250 mg + Pemetrexed 500 mg/m2 | 0.0 | 16.7 |
Run-in Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2 | 0.0 | 50.0 |
All patients were carefully monitored during and after each treatment cycle. Adverse events (AEs) were recorded and were graded according to the National Cancer Institute - Common Terminology Criteria for Adverse Events (CTCAE). (NCT00824408)
Timeframe: From first drug infusion until 21 days after last drug infusion, up to 1100 days
Intervention | participants (Number) | ||||
---|---|---|---|---|---|
CTCAE Grade 1 | CTCAE Grade 2 | CTCAE Grade 3 | CTCAE Grade 4 | CTCAE Grade 5 | |
Randomization Phase: Pemetrexed 500 mg/m2 | 6 | 18 | 15 | 5 | 0 |
Randomization Phase: Volasertib 300 mg | 6 | 12 | 8 | 6 | 3 |
Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2 | 2 | 18 | 19 | 5 | 2 |
Run-in Phase: Volasertib 250 mg + Pemetrexed 500 mg/m2 | 0 | 0 | 3 | 3 | 0 |
Run-in Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2 | 0 | 2 | 3 | 1 | 0 |
2 trials available for pteridines and Fatigue
Article | Year |
---|---|
A Randomized, Open-Label Phase II Trial of Volasertib as Monotherapy and in Combination With Standard-Dose Pemetrexed Compared With Pemetrexed Monotherapy in Second-Line Treatment for Non-Small-Cell Lung Cancer.
Topics: Adult; Aged; Aged, 80 and over; Carcinoma, Non-Small-Cell Lung; Cell Cycle Proteins; Drug Dosage Cal | 2015 |
A phase I open-label dose-escalation study of intravenous BI 2536 together with pemetrexed in previously treated patients with non-small-cell lung cancer.
Topics: Administration, Intravenous; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, | 2013 |