Study of Daraxonrasib (RMC-6236) in Patients With Resected Pancreatic Ductal Adenocarcinoma (PDAC)
Sponsor: Revolution Medicines, Inc.
ClinicalTrials ID:NCT07252232
This Phase 3 global, randomized, open-label study assesses the safety and efficacy of daraxonrasib, a RAS(ON) inhibitor, in improving disease-free survival in patients with resected PDAC post-chemotherapy. Eligible participants are adults with ECOG 0-1, confirmed PDAC, RAS mutation, and adequate organ function. Daraxonrasib is administered orally.
Patient Parameters
| Parameter | Options |
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Program Overview
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.
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.
Eligibility Criteria
Inclusion Criteria
- At least 18 years old and has provided informed consent.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Histologically confirmed PDAC with successful (R0/R1) curative intent surgical resection and no evidence of recurrent or metastatic disease.
- Must have received perioperative (neoadjuvant, adjuvant, or a combination of both) multi-agent chemotherapy.
- Must have completed most recent treatment within the past 12 weeks.
- Adequate organ function (bone marrow, liver, kidney, coagulation).
- Documented RAS mutation status.
- Able to take oral medications.
Exclusion Criteria
- Prior therapy with direct RAS-targeted therapy (eg. degraders and/or inhibitors).
- Any conditions that may affect the ability to take or absorb study drug.
- Major surgery within 28 days prior to randomization.
- Patient is unable or unwilling to comply with protocol-required study visits or procedures.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Taylor Cancer Research Center | 43537 | Maumee | Ohio |
| Avera Cancer Institute | 57105 | Sioux Falls | South Dakota |
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