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RASolute 302: A Phase 3 Multicenter, Open-label, Randomized Study of Daraxonrasib (RMC-6236) Versus Investigator's Choice of Standard of Care Therapy in Patients With Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)
The purpose of this study is to evaluate the safety and efficacy of a novel RAS(ON) inhibitor compared to standard(s) of care (SOC) treatment.
This is a global, randomized, open-label, Phase 3 study designed to evaluate whether treatment with RMC-6236 will improve progression free survival (PFS) or overall survival (OS) compared to Investigator's choice of standard of care chemotherapy in patients with metastatic PDAC who were previously treated with one prior line of therapy with 5-fluorouracil (5-FU) based or gemcitabine-based regimen. Patients will be randomized in a 1:1 ratio to receive RMC-6236 (Arm A) or Investigator's choice of standard of care chemotherapy (Arm B).
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
Mayo Clinic Cancer Center - Phoenix
Phoenix, Arizona, United States
City of Hope-Duarte
Duarte, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
UCLA
Los Angeles, California, United States
UC San Diego Health Moores Cancer Center
San Diego, California, United States
Mission Hall UCSF
San Francisco, California, United States
Rocky Mountain Cancer
Aurora, Colorado, United States
Mayo Clinic Cancer Center - Florida
Jacksonville, Florida, United States
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Start Date
October 16, 2024
Primary Completion Date
June 1, 2026
Completion Date
December 1, 2027
Last Updated
December 12, 2025
501
ACTUAL participants
RMC-6236
DRUG
Gemcitabine
DRUG
nab-paclitaxel
DRUG
Irinotecan
DRUG
Liposomal irinotecan
DRUG
5-fluorouracil
DRUG
leucovorin
DRUG
Oxaliplatin
DRUG
Lead Sponsor
Revolution Medicines, Inc.
NCT04550494
NCT05053971
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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