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 2

CYCLONE 2; NCT03706365

Prostate Cancer

CDK4 & 6 Inhibitor


A Phase 2, 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
  • Males ≥18 years of age
  • Metastatic prostate cancer documented by bone and/or measurable soft tissue disease
  • Serum testosterone level ≤1.73 nmol/L (50 ng/dL)
  • Progressive disease at study entry demonstrated during continuous androgen deprivation therapy (ADT)/post-orchiectomy with at least one of the following:
    • At least two consecutive rising prostate-specific antigen (PSA) values at a minimum of 1 week apart
    • Radiographic progression 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
  • Willing to provide fresh tumor tissue prior to the first dose of study drug
  • Adequate organ function
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Able to swallow pills
Key Exclusion Criteria
  • Previously received a CYP17 inhibitor, abemaciclib, or any CDK4 & 6 inhibitor
  • Previously received cytotoxic chemotherapy for metastatic castration-resistant prostate cancer, radiopharmaceuticals for prostate cancer, enzalutamide, apalutamide, darolutamide, or sipuleucel-T, or prior radiation or surgery to all target lesions
  • Currently receiving an investigational treatment
  • History of any other cancer (except nonmelanoma skin cancer) unless in complete remission with low likelihood of recurrence
  • Serious preexisting medical conditions as judged by the investigator
  • History of adrenal dysfunction, syncope of either unexplained or cardiovascular etiology, ventricular arrhythmia (including but not limited to ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest
  • Clinically significant heart disease defined as:
    • Myocardial infarction or arterial thrombotic events in the past 6 months
    • Severe or unstable angina
    • New York Heart Association (NYHA) class II to IV heart failure or cardiac ejection fraction measurement of <50% during screening
  • Clinically active or chronic liver disease, moderate/severe hepatic impairment (Child-Pugh class B and C), ascites, or bleeding disorders secondary to hepatic dysfunction
  • Active systemic bacterial, fungal, and/or known viral infection
  • Known or suspected central nervous system metastasis
  • Uncontrolled high blood pressure
  • Life expectancy of <6 months
  • Currently being treated with drugs known to be strong inhibitors or strong or moderate inducers of cytochrome P450 3A4 (CYP3A4) and the treatment cannot be discontinued or switched to a different medication
  • Received a live vaccination within 4 weeks prior to the first dose of study drug
  • 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.