Status:
ACTIVE_NOT_RECRUITING
Abemaciclib Plus Darolutamide in Prostate Cancer That Has Spread After Initial Treatment
Lead Sponsor:
Eli Lilly and Company
Collaborating Sponsors:
Bayer
Conditions:
Prostatic Neoplasms
Eligibility:
MALE
18+ years
Phase:
PHASE1
Brief Summary
The main purpose of this study is to learn more about the safety and tolerability of abemaciclib when given in combination with darolutamide to participants with prostate cancer that has spread after ...
Eligibility Criteria
Inclusion
- Histologically confirmed adenocarcinoma of the prostate.
- Metastatic castration-resistant prostate cancer evidenced by:
- Prostate-specific antigen (PSA) or radiographic progression despite castrate levels of testosterone
- At least 1 bone metastasis on bone scan and/or 1 soft tissue metastasis on computed tomography/magnetic resonance imaging (CT/MRI)
- Participants who have not undergone bilateral orchiectomy must continue luteinizing-hormone-releasing hormone (LHRH) agonists/antagonists throughout the study.
- Have adequate organ function.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.
Exclusion
- Prior treatment with cyclin-dependent kinase 4 and 6 (CDK4 and CDK6) inhibitors or darolutamide.
- Prior systemic therapy for metastatic castration-resistant prostate cancer(mCRPC) with cytotoxic chemotherapy, PARP inhibitors, novel hormonal agents (NHAs) (enzalutamide, apalutamide, and abiraterone), and radiopharmaceuticals.
- Serious preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study.
- Clinically significant heart disease as evidenced by myocardial infarction, arterial thrombotic events, severe or unstable angina, or congestive heart failure (New York Heart Association Class III or IV) within 6 months of assignment to treatment.
Key Trial Info
Start Date :
January 12 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05999968
Start Date
January 12 2024
End Date
July 1 2026
Last Update
July 9 2025
Active Locations (13)
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1
Highlands Oncology Group
Springdale, Arkansas, United States, 72762
2
Perlmutter Cancer Center at NYU Langone Hospital - Long Island
Mineola, New York, United States, 11501
3
Laura and Isaac Perlmutter Cancer Center
New York, New York, United States, 10016
4
Studienpraxis Urologie
Nürtingen, Baden-Wurttemberg, Germany, 72622