Trial · NCT01876251
Outcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 21
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 Days 1-21 | All enrolled participants who were eligible, received study treatment, and who either experienced DLT during the first cycle, or completed the 1-cycle observation period. | participants | NUMBER |
| PRIMARY | Progression-free Survival (PFS) at 6 Months - Expansion Cohort | Baseline till 6 months post-dose | The 6-month PFS was evaluated only for the participants in the expansion cohort (PF-03084014 100 mg BID + docetaxel 75 mg/m\^2). Due to early study termination, only 7 participants were treated in the expansion cohort. | months | MEDIAN |
| SECONDARY | Number of Participants With All Causality and Treatment-related Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs | Baseline up to 28-35 days after treatment discontinuation (up to Day 280) | All 29 participants who received study treatment were included in the AE summarization/analysis. | participants | NUMBER |
| SECONDARY | Number of Participants With Laboratory Abnormalities | Baseline up to 28-35 days after treatment discontinuation (up to Day 280) | All 29 participants who received study treatment were included in the safety analyses. | participants | NUMBER |
| SECONDARY | Percentage of Participants With Objective Response (OR) | Baseline, every 6 weeks from Cycle 2 onwards up to 26 months | All 29 participants who received study treatment were included in this analysis. | percentage of participants | NUMBER |
| SECONDARY | Area Under the Concentration-time Curve (AUC) From Time 0 to Time of Last Measured Concentration (AUClast) of PF-03084014 in Dose-finding Cohort | Cycle (C) 1 Days (D) 1, 2, 8, and 21; Day 1 of subsequent cycles and at EOT (max reached: Cycle 12) | All 22 participants treated in the dose escalation stage were included in the analysis. n=number of evaluable participants at the specified time point. | nanogram (ng)*hour (hr)/milliliter (mL) | GEOMETRIC_MEAN |
| SECONDARY | AUClast and AUC From Time 0 Extrapolated to Infinite Time (AUCinf) of Docetaxel in Dose-finding Cohort | C1D1, 2, 8, and 21; D1 of subsequent cycles and at EOT (max reached: C12) | All 22 participants treated in the dose escalation stage were included in the analysis. n=number of evaluable participants at the specified time point. | nanogram (ng)*hour (hr)/milliliter (mL) | GEOMETRIC_MEAN |
| SECONDARY | Maximum Serum or Plasma Concentration (Cmax) and Predose Concentration (Ctrough) of PF-03084014 in Dose-finding Cohort | C1D1, 2, 8, and 21; D1 of subsequent cycles and at EOT (max reached: C12) | All 22 participants treated in the dose escalation stage were included in the analysis. n=number of evaluable participants at the specified time point. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Cmax of Docetaxel in Dose-finding Cohort | C1D1, 2, 8, and 21; D1 of subsequent cycles and at EOT (max reached: C12) | All 22 participants treated in the dose escalation stage were included in the analysis. n=number of evaluable participants at the specified time point. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Time to Cmax (Tmax) of PF-03084014 in Dose-finding Cohort | C1D1, 2, 8, and 21; D1 of subsequent cycles and at EOT (max reached: C12) | All 22 participants treated in the dose escalation stage were included in the analysis. n=number of evaluable participants at the specified time point. | hr | MEDIAN |
| SECONDARY | Tmax of Docetaxel in Dose-finding Cohort | C1D1, 2, 8, and 21; D1 of subsequent cycles and at EOT (max reached: C12) | All 22 participants treated in the dose escalation stage were included in the analysis. n=number of evaluable participants at the specified time point. | hr | MEDIAN |
| SECONDARY | Systemic Clearance (CL) of Docetaxel in Dose-finding Cohort | C1D1, 2, 8, and 21; D1 of subsequent cycles and at EOT (max reached: C12) | All 22 participants treated in the dose escalation stage were included in the analysis. n=number of evaluable participants at the specified time point. | liter (L)/hr | GEOMETRIC_MEAN |
| SECONDARY | Terminal Half-life (t1/2) of Docetaxel in Dose-finding Cohort | C1D1, 2, 8, and 21; D1 of subsequent cycles and at EOT (max reached: C12) | All 22 participants treated in the dose escalation stage were included in the analysis. n=number of evaluable participants at the specified time point. | hr | MEAN |
| SECONDARY | Volume of Distribution (Vss) of Docetaxel in Dose-finding Cohort | C1D1, 2, 8, and 21; D1 of subsequent cycles and at EOT (max reached: C12) | All 22 participants treated in the dose escalation stage were included in the analysis. n=number of evaluable participants at the specified time point. | L | GEOMETRIC_MEAN |
| SECONDARY | AUClast of PF-03084014 in the Expansion Cohort | C1D1, C1D21, and Day 1 of subsequent cycles and at EOT (max reached: C12) | All 7 participants who received treatment in the expansion cohort were included in the analysis. n=number of evaluable participants at the specified time point. | ng*hr/mL | GEOMETRIC_MEAN |
| SECONDARY | Cmax of PF-03084014 in the Expansion Cohort | C1D1, C1D21, and Day 1 of subsequent cycles and at EOT (max reached: C12) | All 7 participants who received treatment in the expansion cohort were included in the analysis. n=number of evaluable participants at the specified time point. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Tmax of PF-03084014 in the Expansion Cohort | C1D1, C1D21, and Day 1 of subsequent cycles and at EOT (max reached: C12) | All 7 participants who received treatment in the expansion cohort were included in the analysis. n=number of evaluable participants at the specified time point. | hr | MEDIAN |
| SECONDARY | Ctrough of PF-03084014 in the Expansion Cohort | C1D1, C1D21, and Day 1 of subsequent cycles and at EOT (max reached: C12) | All 7 participants who received treatment in the expansion cohort were included in the analysis. At Cycle 1 Day 21, only 5 participants had available data for Ctrough. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Duration of Response (DR) | Baseline up to 28-35 days after treatment discontinuation (up to Day 280) | Only 4 participants had CR or PR, 2 each in the PF-03084014 100 mg BID + docetaxel 75 mg/m\^2 and PF-03084014 150 mg BID + docetaxel 75 mg/m\^2 groups. | months | NUMBER |
| SECONDARY | Number of Participants With QTc Values Meeting Categorical Summarization Criteria | Screening, C1D1, C1D21, Day 1 of subsequent cycles, and EOT (maximum reached: C12) | All 29 participants who received study treatment were analyzed for safety. | participants | NUMBER |
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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