At a glance
ClinicalIndex Comparison RecordPhase 3Active· 925 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.
CYCLONE 3: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Abemaciclib in Combination With Abiraterone Plus Prednisone in Men With High-Risk Metastatic Hormone-Sensitive Prostate Cancer
In Brief
A Phase 3 clinical trial evaluating Abemaciclib, Abiraterone, and 2 other interventions for Prostatic Neoplasms and 16 related conditions. Active but no longer recruiting, targeting 925 participants across 266 sites in 24 countries.
Detailed Summary
The purpose of this study is to learn whether adding abemaciclib to abiraterone plus prednisone prolongs the time before prostate cancer gets worse. Participation may last approximately 60 months.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstatic Neoplasms, Neoplasm Metastasis, Urogenital Neoplasms, Physiological Effects of Drugs, Antineoplastic Agents, Antineoplastic Agents, Hormonal, Androgens, Hormones, Hormones, Hormone Substitutes, and Hormone Antagonists, Abiraterone Acetate, Steroid Synthesis Inhibitors, Cytochrome P-450, Enzyme Inhibitors, Prednisone, Prednisolone, Cyclin-Dependent Kinase 4, Cyclin-Dependent Kinase 6
CountriesArgentina, Australia, Belgium, Brazil, Canada, China, Czechia, France, Germany, Greece, Hungary, Israel, Italy, Japan, Mexico, Netherlands, Poland, Romania, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom, United States
Collaborators--
Timeline
Phase 3Active
20232024202520262027
First PostedMar 2022
Enrollment StartApr 2022
Primary CompletionFeb 2024
TodayJul 2026
Study CompletionOct 2027
First PostedMar 21, 2022
Enrollment StartApr 14, 2022
Primary CompletionFeb 15, 2024
Study CompletionOct 1, 2027
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 4.3 years ago
Interventions
Abemaciclibdrug
Administered orally.
Abirateronedrug
Administered orally.
Prednisone or Prednisolonedrug
Administered orally.
Placebo for Abemaciclibdrug
Administered orally.