Clinical trial · Interventional
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)
NCT07252232CI-TRIAL-00123763RASolute 304recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
| PDAC | Pancreatic Ductal Adenocarcinoma | ALIAS | 0.90 |
| PDAC - Pancreatic Ductal Adenocarcinoma | — | UNRESOLVED | — |
| Resectable Pancreatic Ductal Adenocarcinoma (PDAC) | Pancreatic Ductal Adenocarcinoma | CURATED_BROADER | 0.78 |
| Resected Pancreatic Adenocarcinoma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| daraxonrasib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- daraxonrasib
- description
- study drug
- interventionNames
- Drug: daraxonrasib
- type
- NO_INTERVENTION
- label
- SOC Observation
- description
- Patients randomized to the comparator control arm will receive SOC observation.
Primary outcomes (1)
- measure
- Disease-Free Survival (DFS) per Investigator
- timeFrame
- Up to approximately 5 years
- description
- DFS defined as the time from randomization until disease recurrence or death from any cause, whichever occurs first. Recurrence is per response evaluation criteria in solid tumors (RECIST) v1.1 as assessed by Investigator.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.