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.
CYCLONE 2; NCT03706365
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*
Key Inclusion Criteria
- Metastatic prostate cancer documented by positive bone scan and/or measurable soft tissue metastatic lesions by computerized tomography (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:
- Prostate-specific antigen (PSA) progression
- Radiographic progression per 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 CYP17 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)
Contact the Lilly Oncology Clinical Trial Navigation Service
Visit www.clinicaltrials.gov for more information on this trial.
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.