RASolute 304
Research type
Research Study
Full title
RASolute 304: A Phase 3 Multicenter, Open-label, Randomized, 2-Arm Study of Adjuvant Daraxonrasib versus Standard of Care Observation Following Completion of Neoadjuvant and/or Adjuvant Chemotherapy in Patients with Resected Pancreatic Ductal Adenocarcinoma (PDAC)
IRAS ID
1013296
Contact name
Roel Funke
Contact email
Sponsor organisation
Revolution Medicines Inc.
Research summary
The purpose of this study is to test an experimental drug called daraxonrasib (RMC-6236) in patients with localised pancreatic cancer, who have completed curative-intent treatment for their disease (surgery and chemotherapy). Daraxonrasib has not been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) or any other health authorities in any countries. The drug is currently also being investigated in studies in patients with metastatic pancreatic cancer (cancer that has already spread outside of the pancreas). The entire study is expected to last about 5 years. A patient's time in the study will depend on when they joined and whether their cancer comes back. If the cancer comes back, they will continue to be contacted for information about health and survival for a maximum of about 5 years.
-If they agree to join this study, they will be asked to take study drug (daraxonrasib) or to be observed per standard of care. Iare in the study group that is receiving study drug, they will take daraxonrasib for a maximum of 2 years. If they stop treatment
before the end of 2 years, they will be asked to continue to undergo exams and scans to see if their cancer has come back.
-Patients who complete 2 years of treatment or observation without their cancer coming back will be asked to undergo exams and scans for up to 3 more years. After the first 2 years, scans will be scheduled at longer intervals
In both groups, if their cancer comes back, they will be contacted every 6 months after that until the end of the study.REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
25/WM/0251
Date of REC Opinion
19 Jan 2026
REC opinion
Further Information Favourable Opinion