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 1; NCT04408924

Prostate Cancer

CDK4 & 6 Inhibitor


A Phase 2 Study of Abemaciclib in Metastatic Castration-Resistant Prostate Cancer Patients Previously Treated With a Novel Hormonal Agent and Taxane-Based Chemotherapy*

NCT04408924
Key Inclusion Criteria
  • Metastatic prostate cancer for which castration (medical or surgical) is no longer effective (castration resistant)
  • Measurable disease that has spread to soft tissue
  • Documented evidence of progressive disease by prostate-specific antigen (PSA) test or imaging
  • Previously received at least one of the following treatments: abiraterone acetate, apalutamide, darolutamide, or enzalutamide
  • Previously received chemotherapy with docetaxel and cabazitaxel
  • Willing and amenable to undergo a biopsy of tumor tissue (or able to provide adequate archived tumor tissue sample) and to provide blood for research
  • Good physical functioning ability and adequate organ function

Key Exclusion Criteria
  • Received more than three therapy regimens for metastatic castration-resistant prostate cancer (GnRHa, first-generation antiandrogens [flutamide, nilutamide, or bicalutamide], diethylstilbestrol [or other estrogens], corticosteroids, ketoconazole, and bone loss prevention will not count as systemic therapy regimens)
  • Previously received abemaciclib or any other CDK4 & 6 inhibitors
  • Serious and/or uncontrolled preexisting medical condition(s), including but not limited to severe renal impairment, severe hepatic impairment, interstitial lung disease/pneumonitis, severe dyspnea at rest or requiring oxygen therapy, or other serious preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study
  • Confirmed or suspected brain metastasis
  • Untreated spinal cord compression, evidence of spinal metastases with risk of spinal compression, or structurally unstable bone lesions suggesting impending fracture

*
This clinical trial is being conducted globally.
Abemaciclib is administered PO BID.
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.