Trial · NCT02109445
Outcomes30
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 30
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Dose-limiting Toxicities (DLTs) in Cycle 1 | Cycle 1 (28 days) | All enrolled participants who received study treatment and who either experienced DLT during the first cycle, or completed the 1-cycle observation period, were considered evaluable for DLT. Only 2 of the 3 participants were evaluable for DLTs. | participants | NUMBER |
| PRIMARY | Overall Survival (OS) in Phase 2 | From start of study treatment, collected every 3 months until death (up to 5 years) | All randomized participants in Phase 2 were to be analyzed for OS. However, since Phase 2 was not carried out due to early termination, no subjects were analyzed for OS. | ||
| SECONDARY | Number of Participants With Adverse Events (AEs) by Seriousness and Relationship to Treatment in Phase 1 | Baseline up to 28-35 days post last administration of study drug | All enrolled participants in Phase 1 who received at least 1 dose of study medication. | participants | NUMBER |
| SECONDARY | Number of Participants With Adverse Events (AEs) by Seriousness and Relationship to Treatment in Phase 2 | Baseline up to 28-35 days post last administration of study drug | No participants were analyzed since Phase 2 was not performed. | ||
| SECONDARY | Number of Participants With Laboratory Abnormalities in Phase 1 | Screening; Cycle 1 Days 1, 8, 15, 22; up to 28-35 days post last administration of study drug | All participants who received any study treatment. | participants | NUMBER |
| SECONDARY | Number of Participants With Laboratory Abnormalities in Phase 2 | Screening; Days 1, 8, 15 of each cycle; up to 28-35 days post last administration of study drug | Due to early termination, Phase 2 was not performed and thus no participants were included in this analysis. | ||
| SECONDARY | Number of Participants With Clinically Significant Change From Baseline in Vital Signs at Phases 1 and 2 | Baseline up to 28-35 days after treatment discontinuation | All enrolled participants in Phase 1, or all randomized participants in Phase 2, who received at least 1 dose of study medication. Due to early termination of the study, vital sign evaluations were not performed. | ||
| SECONDARY | Number of Participants With Worsening QTc Results in Phase 1 | Screening, Cycle 1 Days 3 and 22, Cycles 2 and 3 Day 1, end of treatment | All enrolled participants in Phase 1 who had at least 1 ECG assessment after receiving PF-03084014. | participants | NUMBER |
| SECONDARY | Number of Participants With Worsening QTc Results in Phase 2 | Screening, Cycle 1 Days 1 and 22, Cycles 2 and 3 Day 1, end of treatment | Due to early termination, Phase 2 was not performed and thus no participants were analyzed for this outcome measure. | ||
| SECONDARY | Area Under the Concentration-time Curve (AUC) for PF-03084014, Nab-P and Gemcitabine in Phase 1 | PF-03084014: Cycle 1 Days 3, 15, 22; Day 1 of subsequent cycles; and end of treatment. nab-P: Cycle 1 Days 1-3 and 15-17. Gemcitabine: Cycle 1 Days 1 and 15. | All treated participants who had at least 1 of the pharmacokinetic (PK) parameters of interest of any of the study drugs. n=number of evaluable participants for that parameter at the specified time point. | nanogram*hour/milliliter (ng*hr/mL) | GEOMETRIC_MEAN |
| SECONDARY | Area Under the Concentration-time Curve (AUC) for PF-03084014, Nab-P and Gemcitabine in Phase 2 | Cycle 1 Day 1 till end of last cycle | As Phase 2 was not performed, no participants were analyzed for this outcome measure. | ||
| SECONDARY | Maximum Observed Plasma Concentration (Cmax) for PF-03084014, Nab-P and GEM in Phase 1 | PF-03084014: Cycle 1 Days 3, 15, 22; Day 1 of subsequent cycles; and end of treatment. nab-P: Cycle 1 Days 1-3 and 15-17. Gemcitabine: Cycle 1 Days 1 and 15. | All treated participants who had at least 1 of the PK parameters of interest of any of the study drugs. n=number of evaluable participants for that parameter at the specified time point. | nanogram/milliliter (ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | Maximum Observed Plasma Concentration (Cmax) for PF-03084014, Nab-P and GEM in Phase 2 | Cycle 1 Day 1 till end of last cycle | As Phase 2 was not performed, no participants were analyzed for this outcome measure. | ||
| SECONDARY | Systemic Clearance (CL) of Nab-paclitaxel in Phase 1 | Cycle 1 Days 1-3, and 15-17 | All treated participants who had at least 1 of the PK parameters of interest of any of the study drugs. n=number of evaluable participants for that parameter at the specified time point. | liter (L)/hour (hr) | GEOMETRIC_MEAN |
| SECONDARY | Systemic Clearance (CL) of Gemcitabine in Phase 1 | Cycle 1 Days 1 and 15 | All treated participants who had at least 1 of the PK parameters of interest of any of the study drugs. n=number of evaluable participants for that parameter at the specified time point. | liter (L)/minute (min) | GEOMETRIC_MEAN |
| SECONDARY | Systemic Clearance (CL) of PF-03084014, Nab-P and GEM in Phase 2 | Cycle 1 Day 1 till end of last cycle | As Phase 2 was not performed, no participants were analyzed for this outcome measure. | ||
| SECONDARY | Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-03084014, Nab-P and GEM in Phase 1 | PF-03084014: Cycle 1 Days 3, 15, 22; Day 1 of subsequent cycles; and end of treatment. nab-P: Cycle 1 Days 1-3 and 15-17. Gemcitabine: Cycle 1 Days 1 and 15. | All treated participants who had at least 1 of the PK parameters of interest of any of the study drugs. n=number of evaluable participants for that parameter at the specified time point. | hours | MEDIAN |
| SECONDARY | Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-03084014, Nab-P and GEM in Phase 2 | Cycle 1 Day 1 till end of last cycle | As Phase 2 was not performed, no participants were analyzed for this outcome measure. | ||
| SECONDARY | Volume of Distribution at Steady State (Vss) for Nab-P and GEM in Phase 1 | Cycle 1 (Days 1 and 15 for gemcitabine; Days 1-3 and 15-17 for nab-paclitaxel) | All treated participants who had at least 1 of the PK parameters of interest of any of the study drugs. n=number of evaluable participants for that parameter at the specified time point. | liters | GEOMETRIC_MEAN |
| SECONDARY | Volume of Distribution at Steady State (Vss) for PF-03084014, Nab-P and GEM in Phase 2 | Cycle 1 Day 1 till end of last cycle | As Phase 2 was not performed, no participants were analyzed for this outcome measure. |
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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