Abemaciclib Plus Darolutamide in Prostate Cancer That Has Spread After Initial Treatment
Reason given: The study was terminated early as related study I3Y-MC-JPCM (NCT03706365) did not meet its primary endpoint.
Key facts
- Where
- Badajoz, L'Hospitalet de Llobregat, Madrid, and Seville, SpainSee the 6 sites
- Phase
- Phase 1
Where in Spain
- Hospital Infanta CristinaBadajoz, SpainNo longer taking part
- Instituto Catalan de Oncologia Hospital Duran i ReynalsL'Hospitalet de Llobregat, SpainNo longer taking part
- Hospital General Universitario Gregorio MarañónMadrid, SpainNo longer taking part
- Hospital Universitario 12 de OctubreMadrid, SpainNo longer taking part
- Hospital Universitario Ramón y CajalMadrid, SpainNo longer taking part
- Hospital Universitario Virgen del RocioSeville, SpainNo longer taking part
Trial details
- Who runs it
- Eli Lilly and Company
- Trial code
- NCT05999968EU 2023-503919-15-00
- Record updated
- 26 June 2026
- Original description
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 initial treatment. Participation may last up to 32 months.Read full original descriptionShow less
A Phase 1b Study of Abemaciclib Plus Darolutamide in Men With Metastatic Castration-Resistant Prostate Cancer
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 initial treatment. Participation may last up to 32 months.
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.