Trial · NCT01876251
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Dose-limiting Toxicities (DLTs) in Cycle 1 | Cycle 1 Days 1-21 | Any DLT event in Cycle 1: Grade 4 neutropenia lasting more than (\>)7 days; febrile neutropenia (Grade more than or equal to \[\>=\] 3 and body temperature \>=38.5 degrees Celsius); Grade \>=3 neutropenic infection; Grade \>=3 thrombocytopenia with bleeding; Grade 4 thrombocytopenia without bleeding; Grade \>=3 toxicities (except those that had not been maximally treated); Grade 3 prolongation of time from electrocardiogram (ECG) Q wave to the end of the T wave corresponding to electrical systole (QT) corrected for heart rate (QTc) which persisted after correction of reversible causes; delay of 2 weeks in receiving next scheduled cycle due to persisting treatment-related toxicities; and failure to deliver at least 80% of planned dose during first cycle due to treatment-related toxicities. |
| Primary | Progression-free Survival (PFS) at 6 Months - Expansion Cohort | Baseline till 6 months post-dose | The period from study entry until disease progression, death or date of last contact. Assessment of response was made using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. |
| 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) | An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent AEs (TEAEs) are defined as newly occurring AEs or those worsening after first dose. AEs comprised both SAEs and non-SAEs. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Causality assessment was made by the investigator. Grading was per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event (CTCAE) version 3.0: Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life-threatening, Grade 5=death related to AE. |
| Secondary | Number of Participants With Laboratory Abnormalities | Baseline up to 28-35 days after treatment discontinuation (up to Day 280) | Number of participants with laboratory test abnormalities without regard to baseline abnormality. Laboratory test parameters included hematology, coagulation, liver function, renal function, electrolytes, clinical chemistry, and urinalysis (dipstick). |
| Secondary | Percentage of Participants With Objective Response (OR) | Baseline, every 6 weeks from Cycle 2 onwards up to 26 months | OR was based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than \[\<\] 10 millimeters \[mm\]). No new lesions. PR was defined as more than or equal to (\>=) 30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. |
| 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) | Serum PF-03084014 pharmacokinetic (PK) parameters were calculated following twice daily (BID) doses of PF-03084014 given alone (Cycle 1 Day 21) and in combination with docetaxel (Cycle 1 Day 2 and Cycle 2 Day 1). |
| 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) | Plasma docetaxel PK parameters were calculated following a 1-hr infusion of docetaxel given alone (Cycle 1 Day 1) and in combination with BID dosing of PF-03084014 (Cycle 2 Day 1) |
| 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) | Serum PF-03084014 PK parameters were calculated following BID doses of PF-03084014 given alone (Cycle 1 Day 21) and in combination with docetaxel (Cycle 1 Day 2 and Cycle 2 Day 1) |
| Secondary | Cmax of Docetaxel in Dose-finding Cohort | C1D1, 2, 8, and 21; D1 of subsequent cycles and at EOT (max reached: C12) | Plasma docetaxel PK parameters were calculated following a 1-hr infusion of docetaxel given alone (Cycle 1 Day 1) and in combination with BID dosing of PF-03084014 (Cycle 2 Day 1) |
| 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) | Serum PF-03084014 PK parameters were calculated following BID doses of PF-03084014 given alone (Cycle 1 Day 21) and in combination with docetaxel (Cycle 1 Day 2 and Cycle 2 Day 1) |
| Secondary | Tmax of Docetaxel in Dose-finding Cohort | C1D1, 2, 8, and 21; D1 of subsequent cycles and at EOT (max reached: C12) | Plasma docetaxel PK parameters were calculated following a 1-hr infusion of docetaxel given alone (Cycle 1 Day 1) and in combination with BID dosing of PF-03084014 (Cycle 2 Day 1) |
| 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) | Plasma docetaxel PK parameters were calculated following a 1-hr infusion of docetaxel given alone (Cycle 1 Day 1) and in combination with BID dosing of PF-03084014 (Cycle 2 Day 1) |
| 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) | Plasma docetaxel PK parameters were calculated following a 1-hr infusion of docetaxel given alone (Cycle 1 Day 1) and in combination with BID dosing of PF-03084014 (Cycle 2 Day 1) |
| 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) | Plasma docetaxel PK parameters were calculated following a 1-hr infusion of docetaxel given alone (Cycle 1 Day 1) and in combination with BID dosing of PF-03084014 (Cycle 2 Day 1) |
| Secondary | AUClast of PF-03084014 in the Expansion Cohort | C1D1, C1D21, and Day 1 of subsequent cycles and at EOT (max reached: C12) | |
| Secondary | Cmax of PF-03084014 in the Expansion Cohort | C1D1, C1D21, and Day 1 of subsequent cycles and at EOT (max reached: C12) | |
| Secondary | Tmax of PF-03084014 in the Expansion Cohort | C1D1, C1D21, and Day 1 of subsequent cycles and at EOT (max reached: C12) | |
| Secondary | Ctrough of PF-03084014 in the Expansion Cohort | C1D1, C1D21, and Day 1 of subsequent cycles and at EOT (max reached: C12) | |
| Secondary | Duration of Response (DR) | Baseline up to 28-35 days after treatment discontinuation (up to Day 280) | Duration of response (DR) defined as time from start of first documented objective tumor response \[Complete Response (CR) or Partial Response (PR)\] to first documented objective tumor progression or death due to any cause, whichever occurs first. DR = (the end date for DR minus first subsequent confirmed CR or PR plus 1) divided by 7.02. CR: disappearance of all target lesions. PR: at least 30% decrease in the sum of diameters of target lesions. |
| Secondary | Number of Participants With QTc Values Meeting Categorical Summarization Criteria | Screening, C1D1, C1D21, Day 1 of subsequent cycles, and EOT (maximum reached: C12) | Criteria for categorical summarization of the time corresponding to the beginning of depolarization to repolarization of the ventricles (QT) corrected for heart rate (QTc) using Bazett's correction (QTcB) or Fridericia's correction (QTcF) included: maximum QTcB or QTcF less than or equal to (\<=) 450 milliseconds (msec), 450 to \<=480 msec, 480 to \<=500 msec, more than (\>) 500 msec; maximum QTcB or QTcF changes (increases/decreases) from baseline (BL) less than (\<) 30 msec, 30 to \<60 msec, more than or equal to (\>=) 60 msec. |
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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