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Loxo@Lilly aims to create medicines that make life better for all those affected by cancer around the world. Bringing together the focus and spirit of a biotech with the scale, resources, and heritage of Lilly, our team is focused on rapidly delivering impactful new medicines for people with cancer. Our approach centers on creating oncology medicines that unequivocally show early signs of clinical activity and will matter to patients.
NCT05999968
Prostate Cancer
CDK4 & 6 Inhibitor
A Phase 1b Study of Abemaciclib Plus Darolutamide in Men With Metastatic Castration-Resistant Prostate Cancer*†
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
Contact the Lilly Oncology Clinical Trial Navigation Service
Visit www.clinicaltrials.gov for more information on this trial.
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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.