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:
Other Countries
Country: Australia
State: New South Wales
City: Kogarah RECRUITING
Facility: St. George Hospital
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Country: Australia
State: New South Wales
City: Randwick RECRUITING
Facility: Prince of Wales Hospital
Contact Info:
[email protected]
612-938-25131
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State: New South Wales
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+61 401 443 282
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City: Herston RECRUITING
Facility: Royal Brisbane and Women's Hospital
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Facility: Epworth HealthCare
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State: Ontario
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State: Ontario
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City: Montreal RECRUITING
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City: Fukuoka RECRUITING
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Facility: Yamaguchi University Hospital
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Facility: National Cancer Center - East
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+81-4-7133-1111
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State: Tokyo
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+81-3-3520-0111
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City: Rotterdam RECRUITING
Facility: Erasmus Medisch Centrum
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+31 (0)10 704 17 54
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City: Utrecht RECRUITING
Facility: St. Antonius Ziekenhuis
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+31 (0)88-3206273
Country: Singapore
City: Singapore RECRUITING
Facility: National Cancer Centre Singapore
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6564368000
Country: Singapore
City: Singapore RECRUITING
Facility: Curie Oncology Pte Ltd
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[email protected]
659 829-7005
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City: Busan RECRUITING
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Country: South Korea
City: Seoul RECRUITING
Facility: Seoul National University Hospital
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Country: South Korea
City: Seoul RECRUITING
Facility: Severance Hospital, Yonsei University Health System
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City: Seoul RECRUITING
Facility: Asan Medical Center - PPDS
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City: Seoul RECRUITING
Facility: Samsung Medical Center
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City: Madrid RECRUITING
Facility: Hospital General Universitario Gregorio Marañon
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City: Madrid RECRUITING
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Facility: Queen Elizabeth Hospital - Birmingham
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City: Liverpool RECRUITING
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Country: United Kingdom
City: London RECRUITING
Facility: Sarah Cannon Research Institute UK
Contact Info:
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02032195200 ext 65218
Country: United Kingdom
City: London RECRUITING
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City: Manchester RECRUITING
Facility: The Christie NHS Foundation Trust
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Country: United Kingdom
State: Devon
City: Torquay RECRUITING
Facility: Torbay Hospital
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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]