A Study to Learn About the Investigational Drug Rinzimetostat (ORIC-944) in Patients With mCRPC Who Were Previously Treated With Abiraterone Acetate (Himalayas-1)

Himalayas-1 is a randomized, open-label, global, multicenter phase 3 study evaluating whether the combination of rinzimetostat with darolutamide is more effective compared to physician's choice of control; ARPI (darolutamide or enzalutamide) or docetaxel for treating patients with metastatic castration resistant prostate cancer (mCRPC) who were previously treated with abiraterone acetate. The primary objective of this study is to demonstrate superiority in radiographic progression free survival (rPFS) of the investigational arm of rinzimetostat + darolutamide combination versus physician's ch

Trial Details

NCT ID
NCT07723248
Phase
PHASE3
Sponsor
ORIC Pharmaceuticals
Status
RECRUITING
Cancer Type
Prostate Cancer
Interventions
  • Rinzimetostat
  • Darolutamide
  • Enzalutamide
  • Docetaxel
Locations (sample)
  • Glendale, California, United States|34.14251,-118.25508
  • Coral Springs, Florida, United States|26.27119,-80.2706
  • Jeffersonville, Indiana, United States|38.27757,-85.73718
  • Holland, Michigan, United States|42.78752,-86.10893
  • Charlotte, North Carolina, United States|35.22709,-80.84313

Key Eligibility Criteria

  • Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features
  • Progressive disease in the setting of surgical or medical castration with evidence of disease progression on treatment with abiraterone acetate in …
  • Metastatic disease in bone documented on bone scan, or in soft tissue documented on CT/MRI scan
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

For full eligibility, visit ClinicalTrials.gov.

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