A Study to Learn About the Investigational Drug Rinzimetostat (ORIC-944) in Patients With mCRPC Who Were Previously Treated With Abiraterone Acetate (Himalayas-1)
Condition(s) studied
Investigational drug(s) / intervention(s)
Rinzimetostat: 400 mg once daily (QD)
Darolutamide: 600 mg twice daily (BID)
Enzalutamide: 160 mg once daily (QD)
Docetaxel: 75 mg/m2 intravenously (IV) every 21 days for up to 10 cycles
Study summary
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.
Eligibility
Primary outcome measure(s)
- Radiographic Progression Free Survival assessed by blinded independent central review (BICR) per RECIST v1.1 and Prostate Cancer Clinical Trials Working Group 3 (PCWG3) — Randomization up to ~2 years
Radiographic Progression Free Survival is defined as the time from the date of randomization to first evidence of radiographic progression as assessed in soft tissue by RECIST 1.1 or in bone per PCWG3 guideline by BICR, or death, whichever occurs first
Trial sites (15)
| Facility | City | Region | Status |
|---|---|---|---|
| Oncura Health | Glendale | California | Recruiting |
| SSAK Partners, LLC | Coral Springs | Florida | Recruiting |
| First Urology PSC | Jeffersonville | Indiana | Recruiting |
| Cancer And Hematology Centers Of Western Michigan | Holland | Michigan | Recruiting |
| Urology Specialists of the Carolinas - University Place | Charlotte | North Carolina | Recruiting |
| Gabrail Cancer Center Research | Canton | Ohio | Recruiting |
| MidLantic Urology LLC | Bala-Cynwyd | Pennsylvania | Recruiting |
| Keystone Urology Specialists | Lancaster | Pennsylvania | Recruiting |
| Carolina Urologic Research Center | Myrtle Beach | South Carolina | Recruiting |
| Urology Associates | Nashville | Tennessee | Recruiting |
| Urology Clinics Of North Texas | Dallas | Texas | Recruiting |
| Urology Partners of North Texas (UPNT) | Fort Worth | Texas | Recruiting |
| Houston Metro Urology (HMU) | Houston | Texas | Recruiting |
| Summit Urology | Murray | Utah | Recruiting |
| BRCR Global (Network) | San Juan | Puerto Rico | Recruiting |
On this site
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Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07723248 on ClinicalTrials.gov ↗ ← All trials in the USA