Using the Drug Daraxonrasib in Surgically Removed Pancreatic Cancer (RASolute 304)
Treatment
Phase III clinical trial to help prevent pancreatic cancer from returning after surgery and chemotherapy
Clinicaltrials.gov identifier:NCT07252232
Study Contact Information:
For additional information:
Name: Revolution Medicines Study Director
Email: [email protected]
Phone Number: 1-844-2-REVMED
About the Study
This is a Phase III, , clinical trial to see if a new drug, Daraxonrasib (RMC-6236), helps prevent pancreatic cancer from returning after surgery and chemotherapy.
Daraxonrasib is a type of drug called a RAS(ON) inhibitor that is meant to selectively block pancreatic cancer growth by targeting specific mutations in the KRAS gene that most pancreatic cancer cells have. Because Daraxonrasib is selective for pancreatic cancer with KRAS mutation, it is a . The study wants to see if this RAS(ON) inhibitor can selectively target pancreatic cancer cells from regrowing after it has been successfully treated with standard-of-care chemotherapy and surgery.
Participants of the study must have had successful treatment of their pancreatic cancer with chemotherapy and surgery that has resulted in no detectable presence of the cancer. This will be a long-term study lasting up to 5 years.
This Study is Open To:
People who are 18 years old and:
- Had pancreatic cancer that was removed with surgery, and has no evidence of the cancer coming back or spreading at the time of enrollment
- Has received multi-agent chemotherapy before and/or after surgery
- Completed the most recent treatment in the last 12 weeks
- Cancer has been confirmed to have RAS mutations
This Study is NOT Open To:
People who:
- Had prior that targets RAS genes
- Have a condition that could affect their ability to absorb the study drug
- Had Major surgery within 28 days of the start of the study
What the Study Involves
There will be two groups in this study: one group receiving the drug Daraxonrasib and the other group receiving standard-of-care observation only. This is an study, so patients will know if they are receiving the drug or not.
Group 1:
- Receives Daraxonrasib as oral tablets
- Has blood tests at certain visits so researchers can measure drug levels in the body
Group 2:
- Undergo follow-up surveillance to monitor for any return of cancer
This study will look at three specific outcomes:
For both groups:
- Disease Free Survival, how long people live without the cancer coming back
- Overall Survival, how long people live, regardless of cause
For Group 2: the safety and side effects of the drug, and how well the drug is absorbed and metabolized in the body
Study Contact Information:
For additional information:
Name: Revolution Medicines Study Director
Email: [email protected]
Phone Number: 1-844-2-REVMED
Locations:
Indiana
City: Indianapolis RECRUITING
Facility: Community Health Network
Contact Info:
[email protected]
(317) 621-3858
Missouri
City: Kansas City RECRUITING
Facility: Saint Luke's Cancer Institute
Contact Info:
[email protected]
(816) 932-2677
Ohio
City: Maumee RECRUITING
Facility: Taylor Cancer Research Center
Contact Info:
[email protected]
567-402-4502
South Dakota
City: Sioux Falls RECRUITING
Facility: Avera Cancer Institute
Contact Info:
[email protected]
605-322-6900
Puerto Rico
City: San Juan RECRUITING
Facility: Pan American Oncology Trials, LLC
Contact Info:
[email protected]
787-407-3333
Treatment
Phase III clinical trial to help prevent pancreatic cancer from returning after surgery and chemotherapy
Clinicaltrials.gov identifier:NCT07252232
Study Contact Information:
For additional information:
Name: Revolution Medicines Study Director
Email: [email protected]
Phone Number: 1-844-2-REVMED