Oncology Pipeline

For more than 50 years, Lilly has been dedicated to delivering life-changing medicines and support to people living with cancer and those who care for them. Lilly is determined to build on this heritage and continue making life better for all those affected by cancer around the world. In 2019 Lilly created Loxo Oncology at Lilly, with the goal of rapidly delivering impactful new medicines for people with cancer. Our approach centers on creating new medicines that work in early clinical development and will matter to patients.

Phase 3  | ENROLLING

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*

NCT03706365
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)
  • Serum testosterone level ≤1.73 nmol/L (50 ng/dL)
  • 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: at least two consecutive rising values at a minimum interval of 1 week. The last value should be ≥1 ng/mL in the absence of radiographic 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
  • Discontinued all previous treatments for cancer (except ADT and bone loss-prevention treatment), and recovered from the acute effects of therapy
  • Adequate organ function
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Able to swallow pills
Key Exclusion Criteria
  • Prior therapy with CYP17 inhibitors (including abiraterone acetate, TAK-700, TOK-001, and ketoconazole)
  • 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
  • Serious preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (eg, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, or a preexisting chronic condition resulting in baseline grade 2 or higher diarrhea)
  • Clinically significant heart disease, active or chronic liver disease, moderate/severe hepatic impairment (Child-Pugh Class B and C)
  • Known or suspected central nervous system metastasis
  • Untreated spinal cord compression or evidence of spinal metastases with risk of spinal compression
*
This clinical trial is being conducted globally.
Abiraterone is administered PO Q24H.
Prednisone/prednisolone is administered PO Q12H.
§
Abemaciclib is administered PO Q12H.
Placebo is administered PO Q12H.
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.