Clinical trial for Metastatic Castration Resistant Prostate Cancer
Official title A Study to Learn About the Investigational Drug Rinzimetostat (ORIC-944) in Patients With mCRPC Who Were Previously Treated With Abiraterone Acetate (Himalayas-1)
ClinicalTrials.gov ID: NCT07723248
What this study is testing
What is Rinzimetostat?
Rinzimetostat is an investigational medicine, being studied as a potential treatment for metastatic castration resistant prostate cancer.
Also referred to as ORIC-944.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to find out if combining rinzimetostat with darolutamide stops the cancer from growing or spreading for a longer time than standard treatments.
- Who it's for
- The study is looking for men with metastatic castration-resistant prostate cancer who have already been treated with abiraterone acetate.
- What's involved
- Participants will receive either the new drug combination or a standard treatment chosen by their doctor, along with regular check-ups and scans to monitor the cancer.
- Time commitment
- The study involves ongoing visits and tests until the cancer grows or spreads, or until the study ends.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- 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
- Adequate organ function
You likely can't join if
- Treatment with first-generation antiandrogen agents (eg, bicalutamide, flutamide, nilutamide), but must be discontinued prior to the first dose of...
- Docetaxel treatment is allowed for mCSPC, as long as no signs of failure or disease progression occurred during treatment or within 3 months of...
- Any other anticancer therapy (drug or vaccine which does not meet exclusion criterion 1 above) within 28 days or 5 half-lives (whichever is longer)...
- Known or suspected brain metastasis or active leptomeningeal disease
- Any medical (including active or clinically significant bacterial, fungal, or viral infection) or psychiatric condition including recent (within the...
- Active inflammatory gastrointestinal disease, chronic diarrhea, or previous gastric resection or lap-band surgery are excluded
The study team makes the final eligibility decision.
Where it is enrolling
- Glendale, California, United States
- Coral Springs, Florida, United States
- Jeffersonville, Indiana, United States
- Holland, Michigan, United States
- Charlotte, North Carolina, United States
- Canton, Ohio, United States
- Bala-Cynwyd, Pennsylvania, United States
- Lancaster, Pennsylvania, United States
- Myrtle Beach, South Carolina, United States
- Nashville, Tennessee, United States
- Dallas, Texas, United States
- Fort Worth, Texas, United States
- Houston, Texas, United States
- Murray, Utah, United States
- San Juan, Puerto Rico
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Glendale, California, United States; Coral Springs, Florida, United States; Jeffersonville, Indiana, United States; Holland, Michigan, United States; Charlotte, North Carolina, United States; Canton, Ohio, United States and 9 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.