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CYCLONE 1; NCT04408924
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*
Key Inclusion Criteria
- Metastatic prostate cancer for which castration (medical or surgical) is no longer effective (castration-resistant)
- Disease spread to soft tissue that is measurable
- Documented evidence of progressive disease by 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
- Availability of metastatic tumor sample (biopsy or recent archival tissue) and to provide blood for research
- Adequate organ function
- Good physical functioning ability
Key Exclusion Criteria
- Previously received abemaciclib or any other CDK4 & 6 inhibitors
- Previously received >3 therapy regimens for metastatic castration-resistant prostate cancer (mCRPC). GnRHa, first-generation antiandrogens (flutamide, nilutamide, or bicalutamide), DES (or other estrogens), corticosteroids, ketoconazole, and bone loss prevention will not count as systemic therapy regimens
- 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
- Untreated spinal cord compression, evidence of spinal metastases with risk of spinal compression, or structurally unstable bone lesions suggesting impending fracture
- Confirmed or suspected brain metastasis
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.