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Phase III Study of Daraxonrasib in Patients with Resected Pancreatic Ductal Adenocarcinoma.
THE PURPOSE OF THIS TRIAL IS TO TEST AN INVESTIGATIONAL DRUG CALLED DARAXONRASIB (RMC-6236). DARAXONRASIB IS AN INVESTIGATIONAL DRUG, WHICH MEANS THAT IT HAS NOT BEEN APPROVED BY THE SPANISH AGENCY FOR MEDICINES AND HEALTH PRODUCTS (AEMPS) OR BY ANY OTHER HEALTH AUTHORITY IN ANY COUNTRY. DARAXONRASIB IS CURRENTLY BEING INVESTIGATED IN OTHER ONGOING STUDIES IN PANCREATIC CANCER, AND ITS SAFETY, TOLERABILITY, AND EFFICACY ARE BEING EVALUATED IN COMPARISON WITH USUAL CLINICAL PRACTICE.
Technical Summary
- RASOLUTE 304: PHASE III, MULTICENTER, OPEN-LABEL, RANDOMIZED, 2-ARM STUDY TO EVALUATE ADJUVANT TREATMENT WITH DARAXONRASIB VERSUS OBSERVATION ACCORDING TO USUAL CLINICAL PRACTICE FOLLOWING COMPLETION OF NEOADJUVANT AND/OR ADJUVANT CHEMOTHERAPY IN PATIENTS WITH RESECTED PANCREATIC DUCTAL ADENOCARCINOMA (PDAC).
- Code EudraCT: 2025-523495-23
- Protocol number: RMC-6236-304
- Promoter: Revolution Medicines, Inc.
- Molecule/Drug: Daraxonrasib
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* The trials only admit a limited number of patients and are subject to inclusion and exclusion criteria. The specialist who assesses your case will inform you of the conditions required to participate in the clinical trial.
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