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

Study acronym: Himalayas-1
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial sites expanded: 7 → 12 locations Eligibility criteria expanded, about 13 words · Secondary endpoints: details revised at 11 of 21 entries Show 2 more changesShow less
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints: details revised at 11 of 21 entries
  2. Trial sites expanded: 2 → 7 locations Start date changed from estimate of Jul 2026 to Aug 3, 2026v2 Show 1 more changeShow less
    • Start date changed from estimate of Jul 2026 to Aug 3, 2026
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 choice of control: ARPI (darolutamide or enzalutamide) or docetaxel.
Trial Details
NCT Number NCT07723248
Lead Sponsor ORIC Pharmaceuticals
Collaborators: Bayer
Conditions Metastatic Castration Resistant Prostate Cancer
Enrollment 600 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov