Trial · NCT02511184
Outcomes33
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 33
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Dose-limiting Toxicity (DLT) | 6 weeks | DLT evaluable population included all participants enrolled in the Dose Finding Phase who received at least 1 dose of crizotinib or pembrolizumab, and either experienced DLT during the first 2 cycles, or completed the observation period for the first 2 cycles of treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Treatment-Emergent Adverse Events | 2 years | The safety analysis set included all enrolled participants who received at least 1 dose of crizotinib or pembrolizumab. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Objective Response Rate (ORR) | Baseline, Week 9 and every 6 weeks thereafter, for about 2 years | The analysis population included all treated participants who had an adequate baseline tumor assessment. | percentage of participants | NUMBER |
| SECONDARY | Duration of Response | Baseline, Week 9 and every 6 weeks thereafter, for about 2 years | The analysis population included all participants who achieved complete response or partial response. | days | MEDIAN |
| SECONDARY | Time to Tumor Response | Baseline, Week 9 and every 6 weeks thereafter, for about 2 years | The analysis population included all participants who achieved complete response or partial response. | days | MEDIAN |
| SECONDARY | Progression Free Survival | Baseline, Week 9 and every 6 weeks thereafter, for about 2 years | The analysis population included all treated participants who had an adequate baseline tumor assessment. | days | MEDIAN |
| SECONDARY | 6-Month, 12-Month and 18-Month Progression Free Survival Probabilities | Month 6, Month 12, and Month 18 | Data were not collected. | ||
| SECONDARY | Overall Survival | Day 1 to end of study (for about 2 years) | The analysis population included all treated participants who had an adequate baseline tumor assessment. | days | MEDIAN |
| SECONDARY | 12-Month and 18-Month Overall Survival Probabilities | Month 12 and Month 18 | Data were not collected. | ||
| SECONDARY | Number of Participants With Maximum Grade in Laboratory Hematology Test Shifting From Grade 0, 1 or 2 at Baseline to Grade 3 or 4 During Treatment | 2 years | The safety analysis set included all enrolled participants who received at least 1 dose of crizotinib or pembrolizumab. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Maximum Grade in Laboratory Chemistry Test Shifting From Grade 0, 1 or 2 at Baseline to Grade 3 or 4 During Treatment | 2 years | The safety analysis set included all enrolled participants who received at least 1 dose of crizotinib or pembrolizumab. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Plasma Concentration Summary of Crizotinib for Crizotinib + Pembrolizumab Group | Prior to crizotinib morning dose on Day 1 of Cycles 1, 2, 4, 6, and 8, and at the End of Treatment visit (28 to 35 days after the last dose of study treatment) | The analysis population included all treated participants who had at least 1 crizotinib concentration measurement. | nanograms/milliliter (ng/mL) | MEDIAN |
| SECONDARY | Plasma Concentration Summary of Crizotinib for Crizotinib Monotherapy Followed by Crizotinib + Pembrolizumab Group | Pre-dose, and 1, 2, 4, 6 and 8 hours post-dose on Day 15 of monotherapy and on Day 1 of Cycle 6; prior to crizotinib morning dose on Day 1 of Cycles 1, 2, 4, 6, and 8, and at the End of Treatment visit (28-35 days after the last dose of study treatment) | The analysis population included all treated participants who had at least 1 crizotinib concentration measurement. | ng/mL | MEDIAN |
| SECONDARY | Time to Maximum Plasma Concentration (Tmax) of Crizotinib for Crizotinib + Pembrolizumab Group | Prior to crizotinib morning dose on Day 1 of Cycles 1, 2, 4, 6, and 8, and at the End of Treatment visit (28 to 35 days after the last dose of study treatment) | Data were not collected. | ||
| SECONDARY | Time to Maximum Plasma Concentration (Tmax) of Crizotinib for Crizotinib Monotherapy Followed by Crizotinib + Pembrolizumab Group | Pre-dose, and 1, 2, 4, 6 and 8 hours post-dose on Day 15 of monotherapy and on Day 1 of Cycle 6; prior to crizotinib morning dose on Day 1 of Cycles 1, 2, 4, 6, and 8, and at the End of Treatment visit (28-35 days after the last dose of study treatment) | Data were not collected. | ||
| SECONDARY | Area Under the Plasma Concentration Time Curve From 0 to 8 Hours (AUC0-8) of Crizotinib for Crizotinib + Pembrolizumab Group | Prior to crizotinib morning dose on Day 1 of Cycles 1, 2, 4, 6, and 8, and at the End of Treatment visit (28 to 35 days after the last dose of study treatment) | Data were not collected. | ||
| SECONDARY | Area Under the Plasma Concentration Time Curve From 0 to 8 Hours (AUC0-8) of Crizotinib for Crizotinib Monotherapy Followed by Crizotinib + Pembrolizumab Group | Pre-dose, and 1, 2, 4, 6 and 8 hours post-dose on Day 15 of monotherapy and on Day 1 of Cycle 6; prior to crizotinib morning dose on Day 1 of Cycles 1, 2, 4, 6, and 8, and at the End of Treatment visit (28-35 days after the last dose of study treatment) | Data were not collected. | ||
| SECONDARY | Area Under the Plasma Concentration Time Curve Over the Dosing Interval (AUCtau) of Crizotinib for Crizotinib + Pembrolizumab Group | Prior to crizotinib morning dose on Day 1 of Cycles 1, 2, 4, 6, and 8, and at the End of Treatment visit (28 to 35 days after the last dose of study treatment) | Data were not collected. | ||
| SECONDARY | Area Under the Plasma Concentration Time Curve Over the Dosing Interval (AUCtau) of Crizotinib for Crizotinib Monotherapy Followed by Crizotinib + Pembrolizumab Group | Pre-dose, and 1, 2, 4, 6 and 8 hours post-dose on Day 15 of monotherapy and on Day 1 of Cycle 6; prior to crizotinib morning dose on Day 1 of Cycles 1, 2, 4, 6, and 8, and at the End of Treatment visit (28-35 days after the last dose of study treatment) | Data were not collected. | ||
| SECONDARY | Apparent Plasma Clearance (CL/F) of Crizotinib for Crizotinib + Pembrolizumab Group | Prior to crizotinib morning dose on Day 1 of Cycles 1, 2, 4, 6, and 8, and at the End of Treatment visit (28 to 35 days after the last dose of study treatment) | Data were not collected. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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