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NCT05288166 · ClinicalTrials.gov registry record · Phase 3
A Study of Abemaciclib (LY2835219) With Abiraterone in Men With Prostate Cancer That Has Spread to Other Parts of the Body and is Expected to Respond to Hormonal Treatment (Metastatic Hormone-Sensitive Prostate Cancer)
A Phase 3 study of Prostatic Neoplasms and Neoplasm Metastasis, sponsored by Eli Lilly and Company.
- Active
- Registry status
- Phase 3
- Development phase
- 925
- Enrollment target
- 20
- Study locations
NCT05288166: Active Phase 3 study of Prostatic Neoplasms and Neoplasm Metastasis, sponsored by Eli Lilly and Company.
NCT05288166 is a Phase 3 study of Prostatic Neoplasms and Neoplasm Metastasis that is active but no longer recruiting, run by Eli Lilly and Company. The registered enrollment target is 925 participants, above the 500-participant average among 65 other Prostatic Neoplasms trials with a reported enrollment target (85% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05288166, a Phase 3 study of Prostatic Neoplasms and Neoplasm Metastasis, is active but no longer recruiting, sponsored by Eli Lilly and Company.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 925 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
The rPFS time is measured from the date of randomization to the earliest date of investigator determined radiographic disease progression (by objective radiographic disease assessment per response evaluation criteria in solid tumors (RECIST) version 1.1 for soft tissue AND/OR radionuclide bone scan using prostate cancer working group 3 -PCWG3 criteria for bone) or death from any cause, whichever occurs first.
Conditions Studied
Interventions
- DRUG Abemaciclib
- DRUG Abiraterone
- DRUG Prednisone or Prednisolone
- DRUG Placebo for Abemaciclib
Study Locations (20)
California
- Orange Coast Memorial Medical Center - Fountain Valley
- Providence Medical Foundation - Fullerton
- Moores Cancer Center - La Jolla
- MemorialCare Health System - Long Beach Medical Center - Long Beach
- Cancer and Blood Specialty Clinic - Los Alamitos
- UCLA Hematology/Oncology - Santa Monica - Los Angeles
- Torrance Memorial Physician Network / Cancer Care - Torrance
- PIH Health Hematology Medical Oncology - Whittier
Colorado
- University of Colorado Anschutz Medical Campus - Aurora
- UCHealth Memorial Hospital - Colorado Springs
- UCHealth Harmony - Fort Collins
- Colorado West Healthcare System - Grand Valley Oncology - Grand Junction
- USO-Rocky Mountain Cancer Center - Littleton
Arizona
- Arizona Oncology Associates, P.C. - HOPE - Prescott
- Arizona Oncology Associates, P.C. - HOPE - Prescott Valley
- The University of Arizona Cancer Center - North Campus - Tucson
Arkansas
- Genesis Cancer and Blood Institute - Hot Springs
- St. Bernards Medical Center - Jonesboro
- Highlands Oncology Group - Springdale
Florida
- Florida Cancer Specialists - South - Fort Myers
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 925 participants |
| Start Date | 2022-04-14 |
| Est. Completion | 2027-10 |
| Phase | Phase 3 |
What the registry record for NCT05288166 still lists
NCT05288166 is an interventional study that assigns participants to a tested intervention. The registered 925 participants enrollment target is mid-sized for trials with a published cap, above the 500-participant average among 65 other Prostatic Neoplasms trials with a reported enrollment target (85% higher).
The record links to 10 conditions, with Prostatic Neoplasms appearing as the primary indexed condition, and to 4 interventions - of which Abemaciclib is the first listed.
NCT05288166 names 20 study sites across 5 states, led by California, Colorado, Arizona.
Frequently Asked Questions
What is clinical trial NCT05288166 about?
NCT05288166 is a clinical study titled "A Study of Abemaciclib (LY2835219) With Abiraterone in Men With Prostate Cancer That Has Spread to Other Parts of the Body and is Expected to Respond to Hormonal Treatment (Metastatic Hormone-Sensitive Prostate Cancer)". 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.
What is the current status of trial NCT05288166?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 925 participants. The study started on 2022-04-14. Estimated completion is 2027-10.
What conditions does trial NCT05288166 study?
This clinical trial studies the following conditions: Prostatic Neoplasms, Neoplasm Metastasis, Urogenital Neoplasms, Physiological Effects of Drugs, Hormones.
What interventions are being tested in trial NCT05288166?
The interventions under investigation include: Abemaciclib (DRUG), Abiraterone (DRUG), Prednisone or Prednisolone (DRUG), Placebo for Abemaciclib (DRUG).
Who is sponsoring clinical trial NCT05288166?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05288166 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Prostatic Neoplasms
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05288166's enrollment target sits among peer trials
925 18th of 65 higher than 48 of 65 other Prostatic Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostatic Neoplasms trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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