Trial · NCT00439270
Outcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Percentage of Participants With a Prostate Specific Antigen (PSA) Response | At pretreatment visit, and on Day 1 of Cycles 2 through 12, then every other cycle, where investigator deems appropriate, and at end of treatment (up to 51.6 months) | All patients who received dasatinib, 100 mg + docetaxel, 75 mg/m\^2 | Percentage of participants | NUMBER |
| PRIMARY | Maximum Tolerated Dose (MTD) of Dasatinib Administered With Docetaxel | From Day 3 of first 21-day cycle to Cycle 2 , Day 21 (or Study Day 42) | All patients who received at least 1 dose of dasatinib in Phase 1 | mg | NUMBER |
| SECONDARY | Duration of Prostate Specific Antigen (PSA) Response | At pretreatment visit, and on Day 1 of Cycles 2 through 12, then every other cycle, where investigator deems appropriate, and at end of treatment | All participants who received dasatinib, 100 mg + docetaxel, 75 mg/m\^2 and who had a PSA response | Months | MEDIAN |
| SECONDARY | Number of Months of Progression-free Survival (PFS) | Patients with an event: time from first dose to disease progression or death, whichever occurs first. Patients without an event: time to last on-study PSA measurement, tumor assessment, or radionuclide bone scan assessment, whichever occurs last | All patients who received dasatinib, 100 mg + docetaxel, 75 mg/m\^2 | Months | MEDIAN |
| SECONDARY | Percentage of Participants With an Objective Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) | Pretreatment visit then every 6 weeks thereafter (up to 51.6 months) | All patients who received dasatinib, 100 mg + docetaxel, 75 mg/m\^2 | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants by Best On-study Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) | Pretreatment visit then every 6 weeks thereafter (up to 51.6 months) | All patients who received dasatinib, 100 mg + docetaxel, 75 mg/m\^2 | Participants | NUMBER |
| PRIMARY | Recommended Phase 2 Dose of Dasatinib Administered With Docetaxel, 75 mg/m^2 | From Day 3 of first 21-day cycle to Cycle 2 , Day 21 (or Study Day 42) | All patients who received at least 1 dose of dasatinib in Phase 1 | mg | NUMBER |
| SECONDARY | Number of Participants by Best On-study Bone Scan Assessment From Baseline | From Day 1 of therapy to last bone scan assessment (up to 51.6 months) | All patients who received dasatinib, 100 mg + docetaxel, 75 mg/m\^2 | Participants | NUMBER |
| SECONDARY | Percentage of Participants With Improvement on Bone Scan | From Day 1 of therapy to last bone scan assessment (up to 51.6 months) | All patients who received dasatinib, 100 mg + docetaxel, 75 mg/m\^2 | Percentage of participants | NUMBER |
| SECONDARY | Baseline Scores and Changes in Pain Intensity From Baseline on the Brief Pain Inventory Short Form (BPI-sf) Scores Through Cycle 6 | At pretreatment visit and on Day 1 of Cycles 2 through 6, then Day 1 of every other cycle, at end of treatment, and at follow-up visit | All patients who received dasatinib, 100 mg + docetaxel, 75 mg/m\^2, in the Phase 2 portion of the study and completed the BPI-sf at baseline. n=evaluable participants in that cycle. | Units on a scale | MEDIAN |
| SECONDARY | Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Drug-related Adverse Events (AEs), Drug-related AEs Leading to Discontinuation, and Drug-related Grade 3 or 4 AEs in the Overall Population | From first dose Day 1 through at least 30 days after last dose of either dasatinib or docetaxel, whichever was later (up to approximately 49 months) | All participants who received at least 1 dose of dasatinib | Participants | NUMBER |
| SECONDARY | Number of Participants With Death as Outcome, Drug-related Serious Adverse Events (SAEs), Drug-related Adverse Events (AEs), Drug-related AEs Leading to Discontinuation, and Drug-related Grade 3 or 4 AEs in the Phase 2 Cohort | From first dose Day 1 through at least 30 days after last dose of either dasatinib or docetaxel, whichever was later (up to approximately 49 months) | All patients who received dasatinib, 100 mg + docetaxel, 75 mg/m\^2 | Participants | NUMBER |
| SECONDARY | Area Under the Concentration-time Curve (AUC) From 0 to 10 Hours Postdose (AUC [0-10])and AUC in 1 Dosing Interval, From Time 0 to 24 Hours (AUC[Tau])of Dasatinib Coadministered With Docetaxel | Cycle 1, Day 14 at 0, 0.5 , 1, 2, 3, 4, 7, 10, and 24 hours postdose | All patients who received at least 1 dose of dasatinib; n=number of patients who were evaluable | ng.h/mL | GEOMETRIC_MEAN |
| SECONDARY | Maximum Observed Plasma Concentration (Cmax) of Dasatinib and of Docetaxel | Docetaxel: Cycle 1, Day 1 at 0, 0.5, 1, 1.25, 1.5, 2, 3, 4, 7, 10, 24, and 48 hours postdose; dasatanib: Cycle 1, Day 14 at 0, .5, 1, 2, 3, 4, 7, 10, and 24 hours postdose | All patients who received at least 1 dose of dasatinib; n=number of patients who were evaluable | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Area Under the Concentration-time Curve (AUC) From Time 0 to Infinity (AUC[Inf]) of Docetaxel | Cycle 1, Day 1 at 0, 0.5, 1, 1.25, 1.5, 2, 3, 4, 7, 10, 24, and 48 hours postdose | All patients who received at least 1 dose of dasatinib | ng.h/mL | GEOMETRIC_MEAN |
| SECONDARY | Number of Participants Meeting the Criteria for On-study Abnormal Results Grade 3-4 of Clinical Laboratory Tests | From Day 2 of Cycle 1 to up to 30 days after last dose of study drug (up to approximately 49 months) | All participants who received at least 1 dose of study drug | 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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GET https://conductscience.org/api/trials/v1/NCT00439270/outcomes