Trial · NCT02584634
Outcomes32
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 32
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Dose-limiting Toxicities (DLTs): Phase 1b | First 2 cycles (1 cycle = 14 days) | The analysis population included all participants enrolled in Phase 1b who were in the safety analysis set (all participants who received at least one dose of study drug), and either experienced DLT during the first 2 cycles (1 cycle = 14 days), or completed the observation period for the first 2 cycles of treatment. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Percentage of Participants With Objective Response (OR): Phase 2 | Screening, Day 1 of each cycle starting Cycle 3, up to end of treatment/withdrawal (maximum of 5 years) | The analysis population included all participants who received at least one dose of study drug. Participants were classified according to the study treatment actually received. If a participant received more than one treatment the participant was classified according to the first treatment received. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With CR for Group B: Phase 2 | Baseline up to 60 months | The analysis population included all participants who received at least one dose of study drug in Group B. Participants were classified according to the study treatment actually received. If a participant received more than one treatment the participant was classified according to the first treatment received. Results for Group A are not reported for this outcome measure according to the protocol. | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Baseline up to 30 days after last dose of study treatment or the day before start day of new anti-cancer therapy (maximum of 5 years) | The analysis population included all participants who received at least one dose of study drug. Participants were classified according to the study treatment actually received. If a participant received more than one study treatment, the participant were classified according to the first treatment received. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Baseline Laboratory Abnormalities Grade <=2 and Post-Baseline Laboratory Abnormalities of Grades 3 or 4 Per NCI CTCAE v4.03 | Screening up to end of treatment/withdrawal (maximum of 5 years) | The analysis population included all participants who received at least one dose of study drug and who could be evaluated for CTCAE criteria for each parameter in each treatment group. Participants were classified according to the study treatment actually received. If a participant received more than one study treatment, the participant was classified according to the first treatment received. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Vital Signs Meeting Pre-defined Criteria | Screening up to end of treatment/withdrawal (maximum of 5 years) | The analysis population included all participants who received at least one dose of study drug. Participants were classified according to the study treatment actually received. If a participant received more than one study treatment, the participant was classified according to the first treatment received. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Disease Control Rate (DCR) | Screening, Day 1 of each cycle starting Cycle 3, up to end of treatment/withdrawal (maximum of 5 years) | The analysis population included all participants who received at least one dose of study drug. Participants were classified according to the study treatment actually received. If a participant received more than one treatment the participant was classified according to the first treatment received. | Percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DR) | Screening, Day 1 of each cycle starting Cycle 3, up to end of treatment/withdrawal (maximum of 5 years) | The analysis population included all participants who received at least one dose of study drug and who had confirmed complete response or partial response. Participants were classified according to the study treatment actually received. If a participant received more than one treatment the participant was classified according to the first treatment received. | Month | MEDIAN |
| SECONDARY | Time to Tumor Response (TTR) | Screening, Day 1 of each cycle starting Cycle 3, up to end of treatment/withdrawal (maximum of 5 years) | The analysis population included all participants who received at least one dose of study drug and who had confirmed complete response or partial response. Participants were classified according to the study treatment actually received. If a participant received more than one treatment the participant was classified according to the first treatment received. | Months | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) | Screening, Day 1 of each cycle starting Cycle 3, up to end of treatment/withdrawal (maximum of 5 years) | The analysis population included all participants who received at least one dose of study drug. Participants were classified according to the study treatment actually received. If a participant received more than one treatment the participant was classified according to the first treatment received. | Months | MEDIAN |
| SECONDARY | Kaplan-Meier Estimates of Overall Survival (OS) | Screening, Day 1 of each cycle starting Cycle 3, up to end of treatment/withdrawal (maximum of 5 years) | The analysis population included all participants who received at least one dose of study drug. Participants were classified according to the study treatment actually received. If a participant received more than one treatment the participant was classified according to the first treatment received. | Months | MEDIAN |
| SECONDARY | Maximum Plasma Concentration (Cmax) of Crizotinib in The Presence of Avelumab | Pre-dose, 1, 2, 4, 6 and 8 hours post dose on Day 1 of Cycle 2 | The analysis population included participants who received at least one dose of study drug and who had at least one of the pharmacokinetic (PK) parameters of interest for crizotinib in Group A. Group B was not evaluable for this outcome measure. | nanograms per millilitre (ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | Time to Cmax (Tmax) of Crizotinib in The Presence of Avelumab | Pre-dose, 1, 2, 4, 6 and 8 hours post dose on Day 1 of Cycle 2 | The analysis population included participants who received at least one dose of study drug and who had at least one of the PK parameters of interest for crizotinib in Group A. Group B was not evaluable for this outcome measure. | Hours | MEDIAN |
| SECONDARY | Area Under The Plasma Concentration-Time Curve During The Dosing Interval Time Course (AUCtau) of Crizotinib in The Presence of Avelumab | Pre-dose, 1, 2, 4, 6 and 8 hours post dose on Day 1 of Cycle 2 | The analysis population included participants who received at least one dose of study drug and who had at least one of the PK parameters of interest for crizotinib in Group A. Group B was not evaluable for this outcome measure. | nanograms*hours per millilitre (ng*h/mL) | GEOMETRIC_MEAN |
| SECONDARY | Apparent Plasma Clearance (CL/F) of Crizotinib in The Presence of Avelumab | Pre-dose, 1, 2, 4, 6 and 8 hours post dose on Day 1 of Cycle 2 | The analysis population included participants who received at least one dose of study drug and who had at least one of the PK parameters of interest for crizotinib in Group A. Group B was not evaluable for this outcome measure. | Liter per hour (L/h) | GEOMETRIC_MEAN |
| SECONDARY | Cmax of Crizotinib Metabolite PF-06260182 in The Presence of Avelumab | Pre-dose, 1, 2, 4, 6 and 8 hours post dose on Day 1 of Cycle 2 | The analysis population included participants who received at least one dose of study drug and who had at least one of the PK parameters of interest for crizotinib in Group A. Group B was not evaluable for this outcome measure. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Tmax of Crizotinib Metabolite PF-06260182 in The Presence of Avelumab | Pre-dose, 1, 2, 4, 6 and 8 hours post dose on Day 1 of Cycle 2 | The analysis population included participants who received at least one dose of study drug and who had at least one of the PK parameters of interest for crizotinib in Group A. Group B was not evaluable for this outcome measure. | Hours | MEDIAN |
| SECONDARY | AUCtau of Crizotinib Metabolite PF-06260182 in The Presence of Avelumab | Pre-dose, 1, 2, 4, 6 and 8 hours post dose on Day 1 of Cycle 2 | The analysis population included participants who received at least one dose of study drug and who had at least one of the PK parameters of interest for crizotinib in Group A. Group B was not evaluable for this outcome measure. | ng*h/mL | GEOMETRIC_MEAN |
| SECONDARY | Metabolite to Parent Ratio for AUCtau (MRAUCtau) of PF-06260182 in The Presence of Avelumab | Pre-dose, 1, 2, 4, 6 and 8 hours post dose on Day 1 of Cycle 2 | The analysis population included participants who received at least one dose of study drug and who had at least one of the PK parameters of interest for crizotinib in Group A. Group B was not evaluable for this outcome measure. | Ratio | GEOMETRIC_MEAN |
| SECONDARY | Metabolite to Parent Ratio for Cmax (MRCmax) of PF-06260182 in The Presence of Avelumab | Pre-dose, 1, 2, 4, 6 and 8 hours post dose on Day 1 of Cycle 2 | The analysis population included participants who received at least one dose of study drug and who had at least one of the PK parameters of interest for crizotinib in Group A. Group B was not evaluable for this outcome measure. | Ratio | GEOMETRIC_MEAN |
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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