Prostate Cancer

CDK4 & 6 Inhibitor

A Phase 1b Study of Abemaciclib Plus Darolutamide in Men With Metastatic Castration-Resistant Prostate Cancer*

show modal icon NCT05999968
Key Inclusion Criteria
  • 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
  • Adequate organ function
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Key Exclusion Criteria
  • Prior treatment with cyclin-dependent kinase (CDK) 4 and 6 inhibitors or darolutamide
  • Prior systemic therapy for metastatic castration-resistant prostate cancer (mCRPC) with cytotoxic chemotherapy, polyadenosine diphosphate-ribose polymerase (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
This clinical trial is being conducted globally.
LHRH agonist/antagonist (physician's choice) is administered in accordance with the prescribing information.
Abemaciclib is administered PO.
Darolutamide is administered PO.
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The safety and efficacy of the agents under investigation have not been established. There is no guarantee that the agents will receive regulatory approval and become commercially available for the uses being investigated.