A Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib (LY2835219) in Participants With Prostate Cancer

Phase 1

• Conditions: Prostate Cancer; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2023-506777-36-00
• Lead Sponsor: Eli Lilly & Co.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-10
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 304

Inclusion Criteria

Histologically confirmed adenocarcinoma of the prostate., Metastatic prostate cancer documented by positive bone scan and/or measurable soft tissue metastatic lesions by CT or magnetic resonance imaging (MRI)., Progressive disease at study entry demonstrated during continuous androgen-deprivation therapy (ADT)/post orchiectomy defined as one or more of the following: PSA progression, Radiographic progression per Response Evaluation Criteria in Solid Tumors (RECIST)1.1 for soft tissue and/or per Prostate Cancer Working Group 3 (PCWG3) for bone, with or without PSA progression, Have adequate organ function., Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.

Exclusion Criteria

Prior therapy with cytochrome P450 (CYP)17 inhibitors., Prior treatment with abemaciclib or any cyclin-dependent kinase (CDK) 4 & 6 inhibitors., Prior cytotoxic chemotherapy for metastatic castration resistant prostate cancer (participants treated with docetaxel in the metastatic hormone-sensitive prostate cancer [mHSPC] are eligible). Prior radiopharmaceuticals for prostate cancer, or prior enzalutamide, apalutamide, darolutamide or sipuleucel-T. Participants who had prior radiation or surgery to all target lesions., Currently enrolled in a clinical study involving an investigational product., Gastrointestinal disorder affecting the absorption or ability to swallow large pills., Clinically significant heart disease, active or chronic liver disease, moderate/severe hepatic impairment (Child-Pugh Class B and C).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified