Using the Drug Daraxonrasib in Surgically Removed Pancreatic Cancer (RASolute 304)

https://www.facingourrisk.org/research-clinical-trials/study/389 /using-the-drug-daraxonrasib-in-surgically-removed-pancreatic-cancer-rasolute-304

Clinicaltrials.gov identifier:
NCT07252232 (https://clinicaltrials.gov/show/NCT07252232)

Treatment
Phase 3 study for pancreatic cancer treatment after surgery and chemotherapy

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, randomized, open-label clinical trial to see if a new drug, Daraxonrasib (RMC-6236), helps prevent pancreatic cancer from returning after surgery and chemotherapy.

Daraxonrasib is a targeted therapy 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.

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 open-label 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

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 targeted therapy 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

About FORCE

FORCE is a national nonprofit organization, established in 1999. Our mission is to improve the lives of individuals and families affected by adult hereditary cancers.