Trial · NCT03706365
Outcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Radiographic Progression Free Survival (rPFS) | From Date of Randomization to Radiographic Disease Progression or Death from Any Cause (Up to 60 Months) | All randomized participants. Participants were analyzed according to the treatment arm they were assigned to regardless of what actual treatment they received. | Months | MEDIAN |
| SECONDARY | Time to Prostate-Specific Antigen (PSA) Progression | From Date of Randomization to the Date of the First Observation of PSA Progression (Up to 60 Months) | All randomized participants. Participants were analyzed according to the treatment arm they were assigned to regardless of what actual treatment they received. | Months | MEDIAN |
| SECONDARY | Radiographic Progression Free Survival (rPFS) Determined by Blinded Independent Central Review | From Date of Randomization Until Radiographic Disease Progression or Death from Any Cause (Up to 60 Months) | All randomized participants. Participants were analyzed according to the treatment arm they were assigned to regardless of what actual treatment they received. | Months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR): Percentage of Participants With a Complete Response (CR) or Partial Response (PR) | Baseline to Radiographic Disease Progression (Up to 60 Months) | All randomized participants who received at least one dose of the study drug and had CR or PR responses. | percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DOR) | Date of First Documented CR or PR to Date of Radiographic Disease Progression or Death from Any Cause (Up to 60 Months) | All randomized participants who received at least one dose of the study drug and had CR or PR responses with objective response. | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | From Date of Randomization to Date of Death Due to Any Cause (Up to 60 Months) | All randomized participants. Participants were analyzed according to the treatment arm they were assigned to regardless of what actual treatment they received. | Months | MEDIAN |
| SECONDARY | Time to Symptomatic Progression | From Randomization to the Date of the First Documented Symptomatic Progression (Up to 60 Months) | All randomized participants. Participants were analyzed according to the treatment arm they were assigned to regardless of what actual treatment they received. | Months | MEDIAN |
| SECONDARY | Pharmacokinetics (PK): Mean Steady State Exposure of Abemaciclib | Cycle (C) 1 Day (D) 1: Predose, 30 min post-dose; C1 D15, C2 D1, C2 D15, C3 D1: Post dose (28 Days Cycle) | All participants who received at least one dose of study drug had evaluable PK data. | nanogram per milliliter (ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | PK: Mean Steady State Exposure of Abemaciclib Metabolite LSN2839567 | C1 D1: Predose, 30 min post-dose; C1 D15, C2 D1, C2 D15, C3 D1: Post dose (28 Days Cycle) | All participants who received at least one dose of study drug had evaluable PK data. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | PK: Mean Steady State Exposure of Abemaciclib Metabolite LSN3106726 | C1 D1: Predose, 30 min post-dose; C1 D15, C2 D1, C2 D15, C3 D1: Post dose (28 Days Cycle) | All participants who received at least one dose of study drug had evaluable PK data. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | PK: Mean Steady State Exposure of Abiraterone Acetate | C1 D15, Post dose | All participants who received at least one dose of study drug had evaluable PK data. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Time to Worst Pain Progression | From Randomization Through Follow-up (Up to 60 months) | All randomized participants. Participants were analyzed according to the treatment arm they were assigned to regardless of what actual treatment they received. | Months | MEDIAN |
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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT03706365/outcomes