CYCLONE 2; NCT03706365

Prostate Cancer

CDK4 & 6 Inhibitor

A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib in Patients With Metastatic Castration-Resistant Prostate Cancer*

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Key Inclusion Criteria
  • Metastatic prostate cancer documented by positive bone scan and/or measurable soft tissue metastatic lesions by CT or MRI
  • Progressive disease at study entry demonstrated during continuous androgen-deprivation therapy (ADT)/post orchiectomy defined as one or more of the following:
    • Prostate-specific antigen (PSA) progression
    • Radiographic progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 for soft tissue and/or per Prostate Cancer Working Group 3 (PCWG3) for bone, with or without PSA progression
  • Adequate organ function
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Key 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 for 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)
This clinical trial is being conducted globally.
Abiraterone, prednisone (or prednisolone), and abemaciclib or placebo equivalent are 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.