Trial · NCT02573259
Outcomes25
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 25
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Dose-Limiting Toxicities (DLT) - Part 1 | Cycle 1 in Part 1 (21 days for IV administration of PF-06801591; 28 days for SC administration of PF-06801591) | DLT analysis population included all enrolled participants who received at least 1 dose of study treatment and who did not have major treatment deviations during Cycle 1. | Percentage of Participants | NUMBER |
| PRIMARY | Number of Participants With All-Causality Treatment-Emergent Adverse Events (AEs) - Part 1 and Part 2 | Baseline up to 28 days after last dose of study treatment (maximum of 1634 days) | Analysis population included all enrolled participants who received at least 1 dose of study medication. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (AEs) - Part 1 and Part 2 | Baseline up to 28 days after last dose of study treatment (maximum of 1634 days) | Analysis population included all enrolled participants who received at least 1 dose of study medication. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | Baseline up to 28 days after last dose of study treatment (maximum of 1634 days) | Analysis population included all enrolled participants who received at least 1 dose of study medication. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Objective Response Rate (ORR) Based on RECIST Version 1.1 - Part 2 | Baseline up to end of treatment in Part 2 (maximum of 851 days) | Analysis population included all the randomized participants who received at least 1 dose of study medication, had measurable disease baseline assessment (within 28 days prior to study entry) and at least 1 post baseline assessment or disease progression, global deterioration of health status, or death. | Percentage | NUMBER |
| PRIMARY | Objective Response Rate (ORR) Based on Immune Related RECIST (irRECIST) - Part 2 | Baseline up to end of treatment in Part 2 (maximum of 851 days) | Analysis population included all the randomized participants who received at least 1 dose of study medication, had measurable disease baseline assessment (within 28 days prior to study entry) and at least 1 post baseline assessment or disease progression, global deterioration of health status, or death. | Percentage of Participants | NUMBER |
| SECONDARY | Maximum Plasma Concentration (Cmax) of PF-06801591 - Part 1 | Pre-dose, 1 and 24 hours post dose on Cycle 1 Day 1, and pre-dose and 1 hour post dose on Cycle 4 Day 1 in Part 1 | Analysis population included all enrolled participants treated who were evaluable for this outcome measure. | ug/mL | GEOMETRIC_MEAN |
| SECONDARY | AUClast of PF-06801591 in Part 1. | Pre-dose, 1 and 24 hours post dose on Cycle 1 Day 1 in Part 1 | Analysis population included all enrolled participants treated who were evaluable for this outcome measure. | ug*hr/mL | GEOMETRIC_MEAN |
| SECONDARY | Clearance (CL) of PF-06801591 - Part 1 | Pre-dose, 1 and 24 hours post dose on Cycle 1 Day 1, and pre-dose and 1 hour post dose on Cycle 4 Day 1 in Part 1 | Analysis population included all enrolled participants treated who were evaluable for this outcome measure. | L/hr | GEOMETRIC_MEAN |
| SECONDARY | Volume of Distribution at Steady State (Vss) of PF-06801591 - Part 1 | Pre-dose, 1 and 24 hours post dose on Cycle 1 Day 1, and pre-dose and 1 hour post dose on Cycle 4 Day 1 in Part 1 | The PK parameter analysis population was defined as all enrolled participants in Part 1 who received study drug following IV administration and had sufficient information to estimate at least 1 of the pharmacokinetic (PK) parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants who had reportable parameter values of Vss. | L | GEOMETRIC_MEAN |
| SECONDARY | Accumulation Ratio (Rac) of PF-06801591 - Part 1 | Pre-dose and 1 hour post dose on Day 1 of Cycles 1 and 4 in Part 1 | Analysis population included all enrolled participants treated who were evaluable for this outcome measure. | Ratio | GEOMETRIC_MEAN |
| SECONDARY | Terminal Elimination Half-Life (t1/2) of PF-06801591 - Part 1 | Pre-dose and 1 hour post dose on Day 1 of Cycles 1 and 4 in Part 1 | The PK parameter analysis population was defined as all enrolled participants in Part 1 who received study drug following IV or SC administration and had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants who had reportable parameter values of t1/2. | Days | MEAN |
| SECONDARY | Number of Participants With Anti-Drug Antibody (ADA) Against PF-06801591 - Part 1 and Part 2 | Baseline up to end of treatment (maximum of 851 days) | Analysis population included all participants who received at least 1 dose of study treatment and had at least 1 post-treatment ADA result. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Neutralizing Antibodies (NAb) Positive Against PF-06801591 - Part 1 and Part 2 | Baseline up to end of treatment (maximum of 851 days) | Analysis population included all participants who received at least 1 dose of study treatment and had at least 1 post-treatment ADA result. NAb-negative participants included participants who were ADA negative or ADA-positive participants who tested negative in the NAb assay. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Baseline PD-1 Receptor Occupancy (RO) by PF-06801591 - Part 1 | Baseline, Days 1, 8, 15, 21 of Cycle 1, Day 1 of Cycles 2, 3, 5, Days 1, 15, 21 of Cycle 4, and end of treatment (EOT) in Part 1 (cycle = 21 days for IV dosing; cycle = 28 days for SC dosing) | Analysis population included all enrolled participants with at least 1 of the pharmacodynamic/biomarker parameters evaluated at pre- and/or post dose. | Percentage of Baseline | MEDIAN |
| SECONDARY | Number of Participants Achieving Objective Response (OR) Based on RECIST Version 1.1 - Part 1 | Baseline up to end of treatment in Part 1 (maximum of 1606 days) | Analysis population included all the randomized participants who received at least 1 dose of study medication, had measurable disease baseline assessment (within 28 days prior to study entry) and at least 1 post baseline assessment or disease progression, global deterioration of health status, or death. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Achieving Objective Response (OR) Based on irRECIST - Part 1 | Baseline up to end of treatment in Part 1 (maximum of 1606 days) | Analysis population included all the randomized participants who received at least 1 dose of study medication, had measurable disease baseline assessment (within 28 days prior to study entry) and at least 1 post baseline assessment or disease progression, global deterioration of health status, or death. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Progression-Free Survival (PFS) Based on RECIST Version 1.1 and irRECIST - Part 1 and Part 2 | Baseline up to end of treatment (maximum of 1606 days) | Analysis population included all the randomized participants who received at least 1 dose of study medication, had measurable disease baseline assessment (within 28 days prior to study entry) and at least 1 post baseline assessment or disease progression, global deterioration of health status, or death. | Months | MEDIAN |
| SECONDARY | Duration of Stable Disease (DOSD) Based on RECIST Version 1.1 and irRECIST - Part 1 and Part 2 | Baseline up to end of treatment (maximum of 1606 days) | Analysis population included all the randomized participants who received at least 1 dose of study medication, had measurable disease baseline assessment (within 28 days prior to study entry) and at least 1 post baseline assessment or disease progression, global deterioration of health status, or death. | Months | MEDIAN |
| SECONDARY | Duration of Response (DOR) Based on RECIST Version 1.1 and irRECIST - Part 1 and Part 2 | Baseline up to end of treatment (maximum of 1606 days) | Analysis population included all the randomized participants who received at least 1 dose of study medication, had measurable disease baseline assessment (within 28 days prior to study entry) and at least 1 post baseline assessment or disease progression, global deterioration of health status, or death. DOR was only applicable to those participants with an objective response. | Months | MEDIAN |
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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