Trials / Recruiting
RecruitingNCT07252232
Study of Daraxonrasib (RMC-6236) in Patients With Resected Pancreatic Ductal Adenocarcinoma (PDAC)
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)
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 500 (estimated)
- Sponsor
- Revolution Medicines, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the safety and efficacy of a novel RAS(ON) inhibitor compared to standard of care (SOC) observation only.
Detailed description
This is a global, randomized, open-label, Phase 3 study designed to evaluate whether treatment with daraxonrasib will improve disease-free survival (DFS) compared to SOC observation in patients with resected PDAC who have completed neoadjuvant and/or adjuvant chemotherapy.
Conditions
- Pancreatic Cancer
- PDAC
- PDAC - Pancreatic Ductal Adenocarcinoma
- Resectable Pancreatic Ductal Adenocarcinoma (PDAC)
- Resected Pancreatic Adenocarcinoma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | daraxonrasib | oral tablets |
Timeline
- Start date
- 2025-12-15
- Primary completion
- 2029-05-10
- Completion
- 2030-07-10
- First posted
- 2025-11-26
- Last updated
- 2026-04-06
Locations
15 sites across 3 countries: United States, Puerto Rico, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07252232. Inclusion in this directory is not an endorsement.