Using the Drug Daraxonrasib in Surgically Removed Pancreatic Cancer (RASolute 304)
Treatment
Phase 3 study for pancreatic cancer treatment 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 that keeps pancreatic cancer cells from growing by targeting specific mutations in the KRAS gene that are found in most pancreatic cancer cells. The study is testing daraxonrasib to see if it selectively targets pancreatic cancer cells from regrowing after the cancer has been successfully treated with standard-of-care chemotherapy and surgery.
Participants of the study must have completed 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:
California
City: Los Angeles RECRUITING
Facility: University of California, Los Angeles
Contact Info:
No contact info provided
Connecticut
City: Hartford RECRUITING
Facility: Hartford Healthcare
Contact Info:
[email protected]
(860) 972-4183
Indiana
City: Indianapolis RECRUITING
Facility: Community Health Network
Contact Info:
[email protected]
(317) 621-3858
Maryland
City: Baltimore RECRUITING
Facility: Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins
Contact Info:
No contact info provided
Missouri
City: Kansas City RECRUITING
Facility: Saint Luke's Cancer Institute
Contact Info:
[email protected]
(816) 932-2677
New York
City: New York RECRUITING
Facility: Memorial Sloan Kettering Cancer Center
Contact Info:
No contact info provided
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
Utah
City: Salt Lake City RECRUITING
Facility: University of Utah, Huntsman Cancer Institute
Contact Info:
No contact info provided
Virginia
City: Fairfax RECRUITING
Facility: Virginia Cancer Specialists
Contact Info:
No contact info provided
Puerto Rico
City: San Juan RECRUITING
Facility: Pan American Oncology Trials, LLC
Contact Info:
[email protected]
787-407-3333
Other Countries
Country: United Kingdom
City: Birmingham RECRUITING
Facility: University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Medical Centre
Contact Info:
No contact info provided
Country: United Kingdom
City: London RECRUITING
Facility: The Royal Marsden NHS Foundation Trust, Royal Marsden Hospital-London
Contact Info:
No contact info provided
Country: United Kingdom
City: London RECRUITING
Facility: Imperial College Healthcare NHS Foundation Trust, Hammersmith Hospital
Contact Info:
No contact info provided
Treatment
Phase 3 study for pancreatic cancer treatment 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