Trial · NCT03150056
Outcomes29
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 29
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to 21.3 months | All Treated Population consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With AEs Leading to Any Dose Reduction or Delays | Up to 21.3 months | All Treated Population. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Who Withdrew Due to Toxicity and Changes in Safety Assessment | Up to 21.3 months | All Treated Population. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Percentage of Participants With Greater Than or Equals to (>=)50 Percent (%) Decrease in Prostate-specific Antigen From Baseline (PSA50) | Up to 21.3 months | Modified All Treated Population comprised of all participants who received at least one dose of GSK525762 plus abiraterone/enzalutamide. Only those participants with data available at the indicated time points were analyzed. | Percentage of participants | NUMBER |
| SECONDARY | Maximum Observed Plasma Concentration (Cmax) of GSK525762 and Its Active Metabolites GSK3529246 | Pre-dose, 30 minutes, 1, 3, 6 to 12, 24 hours post-dose on Day 1 of Weeks 1 and 3 | PK Population. Only those participants with data available at the indicated time points were analyzed (indicated by n=X in category titles). | Nanogram per milliliter | GEOMETRIC_MEAN |
| SECONDARY | Time to Cmax (Tmax) of GSK525762 and Its Active Metabolites GSK3529246 | Pre-dose, 30 minutes, 1, 3, 6 to 12, 24 hours post-dose on Day 1 of Weeks 1 and 3 | PK Population. Only those participants with data available at the indicated time points were analyzed (indicated by n=X in category titles). | Hours | MEDIAN |
| SECONDARY | Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval (AUC[0-tau]) of GSK525762 and Its Active Metabolites GSK3529246 | Pre-dose, 30 minutes, 1, 3, 6 to 12, 24 hours post-dose on Day 1 of Weeks 1 and 3 | PK Population. Only those participants with data available at the indicated time points were analyzed (indicated by n=X in category titles). | Hours*nanogram per milliliter | GEOMETRIC_MEAN |
| SECONDARY | Trough Concentration (Ctrough) of GSK525762 and Its Active Metabolites GSK3529246 | Pre-dose, 30 minutes, 1, 3, 6 to 12, 24 hours post-dose on Day 1 of Weeks 1 and 3 | PK Population. Only those participants with data available at the indicated time points were analyzed (indicated by n=X in category titles). | Nanogram per milliliter | GEOMETRIC_MEAN |
| SECONDARY | Cmax of Abiraterone | Pre-dose, 30 minutes, 1, 3, 6 to 12, 24 hours post-dose on Day 1 of Weeks 1 and 3 | PK Population. Only those participants with data available at the indicated time points were analyzed (indicated by n=X in category titles). | Nanogram per milliliter | GEOMETRIC_MEAN |
| SECONDARY | Tmax of Abiraterone | Pre-dose, 30 minutes, 1, 3, 6 to 12, 24 hours post-dose on Day 1 of Weeks 1 and 3 | PK Population. Only those participants with data available at the indicated time points were analyzed (indicated by n=X in category titles). | Hours | MEDIAN |
| SECONDARY | AUC(0-tau) of Abiraterone | Pre-dose, 30 minutes, 1, 3, 6 to 12, 24 hours post-dose on Day 1 of Weeks 1 and 3 | PK Population. Only those participants with data available at the indicated time points were analyzed (indicated by n=X in category titles). | Hours*nanogram per milliliter | GEOMETRIC_MEAN |
| SECONDARY | Ctrough of Abiraterone | Pre-dose, 30 minutes, 1, 3, 6 to 12, 24 hours post-dose on Day 1 of Weeks 1 and 3 | PK Population. Only those participants with data available at the indicated time points were analyzed (indicated by n=X in category titles). | Nanogram per milliliter | GEOMETRIC_MEAN |
| SECONDARY | Cmax of Enzalutamide | Pre-dose on Day 1 of Weeks 1, 3, 5, 9, 17 and 25 | PK Population. Cmax could not be derived as only pre-dose samples were collected. | Microgram per milliliter | GEOMETRIC_MEAN |
| SECONDARY | Tmax of Enzalutamide | Pre-dose on Day 1 of Weeks 1, 3, 5, 9, 17 and 25 | PK Population. Tmax could not be derived as only pre-dose samples were collected. | Hours | MEDIAN |
| SECONDARY | AUC(0-tau) of Enzalutamide | Pre-dose on Day 1 of Weeks 1, 3, 5, 9, 17 and 25 | PK Population. AUC(0-tau) could not be derived as only pre-dose samples were collected. | Hours*microgram per milliliter | GEOMETRIC_MEAN |
| SECONDARY | Ctrough of Enzalutamide | Pre-dose on Day 1 of Weeks 1, 3, 5, 9, 17 and 25 | PK Population. Only those participants with data available at the indicated time points were analyzed (indicated by n=X in category titles). | Microgram per milliliter | GEOMETRIC_MEAN |
| SECONDARY | Disease Control Rate at Week 24 | Week 24 | Modified All Treated Population. Only those participants with data available at the indicated time points were analyzed. | Percentage of participants | NUMBER |
| SECONDARY | Composite Response Rate | Up to 21.3 months | Modified All Treated Population. | Percentage of participants | NUMBER |
| SECONDARY | Objective Response Rate | Up to 21.3 months | Modified All Treated Population. Only those participants with data available at the indicated time points were analyzed. | Percentage of participants | NUMBER |
| SECONDARY | Circulating Tumor Cells (CTC) Response Rate | Up to 21.3 months | Modified All Treated Population. Only those participants with data available at the indicated time points were analyzed. For GSK525762 40 mg+Abiraterone 1000 mg arm, there were no unfavorable values at Baseline, hence CTC response rate (change from unfavorable to favorable) could not be derived for this arm. | Percentage of 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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