Actively Recruiting
RASolute 303: Phase 3 Study of Daraxonrasib Alone or With Gemcitabine and Nab-paclitaxel Versus Gemcitabine and Nab-paclitaxel Alone for First-Line Treatment of Metastatic Pancreatic Adenocarcinoma
Led by Revolution Medicines, Inc. · Updated on 2026-06-03
900
Participants Needed
5
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The trial investigates the use of daraxonrasib, an investigational RAS(ON) inhibitor, alone or combined with chemotherapy, for patients with metastatic pancreatic adenocarcinoma. It aims to compare these treatments against the standard chemotherapy of gemcitabine and nab-paclitaxel to evaluate progression-free survival and overall survival. This Phase 3, randomized, open-label study addresses the need for improved first-line treatment options in this condition. Participants are randomly assigned to one of three groups: daraxonrasib alone, daraxonrasib combined with gemcitabine and nab-paclitaxel, or gemcitabine and nab-paclitaxel alone. Daraxonrasib is given as oral tablets, while gemcitabine and nab-paclitaxel are administered by intravenous infusion. Treatment is given as a first-line therapy for metastatic pancreatic adenocarcinoma. Throughout the study, participants undergo assessments including tumor measurements, laboratory tests, vital sign monitoring, and quality of life questionnaires. Researchers will track progression-free survival and overall survival for up to two years, along with response rates and adverse events. The study involves regular visits for safety monitoring and evaluation of treatment effects over the study period.
CONDITIONS
Brief Title
Study of Daraxonrasib and Daraxonrasib + GnP as First-line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years old and has provided informed consent
- ECOG performance status of 0 or 1
- Histologically or cytologically confirmed pancreatic adenocarcinoma
- Diagnosis of metastatic disease within 6 weeks before consent
- Documented RAS mutation status, mutant or wild-type
- Measurable disease per RECIST v1.1
- Adequate organ function (bone marrow, liver, kidney, coagulation)
- Able to take oral medications
You will not qualify if you...
- Prior systemic anticancer therapy for metastatic disease or prior RAS-targeted therapy
- Active or untreated central nervous system metastatic disease
- Conditions affecting ability to take or absorb study drug
- Major surgery within 28 days before randomization
- Unable or unwilling to comply with study visits or procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 2 years
Participants receive daraxonrasib alone, daraxonrasib with gemcitabine and nab-paclitaxel, or gemcitabine and nab-paclitaxel as first-line treatment for metastatic pancreatic adenocarcinoma.
Repeated treatment cycles every 28 days with regular visits for assessments
Trial Site Locations
Total: 5 locations
1
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States, 21287
Actively Recruiting
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
3
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, United States, 89052
Actively Recruiting
4
Taylor Cancer Research Center
Maumee, Ohio, United States, 43537
Actively Recruiting
5
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Actively Recruiting
Research Team
R
Revolution Medicines Study Director
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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