Comparing the Targeted Therapy Daraxonrasib With or Without Chemotherapy to Chemotherapy Alone for First-Line Treatment of Metastatic Pancreatic Cancer (RASolute 303)
Treatment
Phase 3 Study for First-Line Treatment of Metastatic Pancreatic Cancer
Clinicaltrials.gov identifier:NCT07491445
Study Contact Information:
For additional information, contact:
Revolution Medicines Study Director
📞 1-844-2-REVMED
📧 [email protected]
About the Study
This study is testing a new targeted drug called daraxonrasib to see if it helps people with pancreatic cancer live longer or keep their cancer from growing longer than standard chemotherapy alone. Researchers are comparing daraxonrasib by itself or combined with chemotherapy to standard chemotherapy.
Daraxonrasib is an oral designed to block a pathway called RAS, which plays a role in many pancreatic cancers. Daraxonrasib is not FDA‑approved and is only available through participation in a clinical trial or through a program known as . You can read more about for daraxonrasib.
This Study is Open To:
In order to participate, people must meet all of the following:
- Have pancreatic (the most common type of pancreatic cancer) that is (has spread outside the pancreas and surrounding area).
- Have not received any treatment for disease.
- Have measurable disease (the cancer can be seen and measured on scans so doctors can track how it responds to treatment).
- Have good overall physical functioning.
- Have had testing on their cancer to look at a known as a RAS mutation. People may be eligible regardless of their RAS mutation results (either mutated or not mutated).
- Must be able to swallow oral medication
- Adequate organ function (bone marrow, liver, kidney, coagulation).
This Study is NOT Open To:
People with any of the following cannot join the study:
- Have already received treatment for pancreatic cancer
- Have previously received a RAS‑targeted therapy.
- Have active or untreated spread to the brain or central nervous system.
- Have any other conditions that may affect the ability to take or absorb the study drug.
What the Study Involves
Participants are randomly assigned (by chance) to one of three groups. Participants do not get to choose which group they will be in.
Daraxonrasib alone (oral )
Participants in this group will take daraxonrasib orally (by mouth) every day.
Participants will continue taking daraxonrasib as long as it is helping, their cancer isn't growing and side effects are manageable.
Daraxonrasib plus chemotherapy
Participants in this group will take daraxonrasib orally (by mouth) every day.
Participants will also receive two chemotherapy drugs intravenously (injection in the veins).
- Gemcitabine (IV)
- Nab‑paclitaxel (IV)
Participants will receive chemotherapy in 28‑day cycles, with treatment given on specific days during each cycle, followed by rest periods.
Participants in this group will continue taking daraxonrasib and chemotherapy as long as it is helping and side effects are manageable.
Standard chemotherapy alone
Participants in this group will receive two chemotherapy drugs intravenously (injection in the veins).
- Gemcitabine (IV)
- Nab‑paclitaxel (IV)
Participants will receive chemotherapy in 28‑day cycles, with treatment given on specific days during each cycle, followed by rest periods.
Participants in this group will continue taking chemotherapy as long as it is helping and side effects are manageable.
All participants
Participants can expect regular monitoring, which may include:
- Clinic visits including physical exams and vital signs checks.
- Blood tests to check organ function and measure drug levels.
- Imaging scans (such as CT or ) to see whether the cancer is shrinking, stable, or growing.
- Questionnaires about symptoms and quality of life, including pain and daily functioning.
- Monitoring for side effects, including recording and grading any adverse events.
Additional Considerations
- Participants are randomly assigned to a treatment group and do not get to choose which treatment they receive.
- Some participants may receive standard chemotherapy alone.
- Daraxonrasib is investigational and only available through research studies or the program.
Study Contact Information:
For additional information, contact:
Revolution Medicines Study Director
📞 1-844-2-REVMED
📧 [email protected]
Locations:
Massachusetts
City: Boston RECRUITING
Facility: Dana-Farber Cancer Institute
Contact Info:
[email protected]
857-215-2351
Maryland
City: Baltimore RECRUITING
Facility: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Contact Info:
[email protected]
410-955-8152
Nevada
City: Henderson RECRUITING
Facility: Comprehensive Cancer Centers of Nevada
Contact Info:
[email protected]
702-609-9460
Ohio
City: Maumee RECRUITING
Facility: Taylor Cancer Research Center
Contact Info:
[email protected]
567-402-4502
Washington
City: Seattle RECRUITING
Facility: Virginia Mason Medical Center
Contact Info:
[email protected]
206-287-6273
Treatment
Phase 3 Study for First-Line Treatment of Metastatic Pancreatic Cancer
Clinicaltrials.gov identifier:NCT07491445
Study Contact Information:
For additional information, contact:
Revolution Medicines Study Director
📞 1-844-2-REVMED
📧 [email protected]