At a glance
ClinicalIndex Comparison RecordPhase 3Active· 393 enrolled
Drug / intervention
Abemaciclib +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib in Patients With Metastatic Castration-Resistant Prostate Cancer
In Brief
A Phase 3 clinical trial evaluating Abemaciclib, Placebo, and 2 other interventions for Prostate Cancer. Active but no longer recruiting, targeting 393 participants across 112 sites in 11 countries.
Detailed Summary
This study is being done to see how safe and effective abemaciclib is when given together with abiraterone acetate plus prednisone in participants with metastatic castration resistant prostate cancer. Prednisolone may be used instead of prednisone per local regulation.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesAustralia, China, Denmark, France, Germany, Japan, Netherlands, Romania, South Korea, Spain, United States
Collaborators--
Timeline
Phase 3ActiveOverdue
20192020202120222023202420252026
First PostedOct 2018
Enrollment StartNov 2018
Primary CompletionJan 2024
Study CompletionJun 2026
TodayJul 2026
First PostedOct 16, 2018
Enrollment StartNov 26, 2018
Primary CompletionJan 2, 2024
Study CompletionJun 1, 2026
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 7.7 years ago
Interventions
Abemaciclibdrug
Administered orally.
Placebodrug
Administered orally.
Abiraterone acetatedrug
Administered orally.
Prednisonedrug
Administered orally.