Phase 3 Study of Daraxonrasib (RMC-6236) in Patients With Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)
Purpose
The purpose of this study is to evaluate the safety and efficacy of a novel RAS(ON) inhibitor compared to standard(s) of care (SOC) treatment.
Conditions
- Pancreatic Cancer
- PDAC
- PDAC - Pancreatic Ductal Adenocarcinoma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- At least 18 years old and has provided informed consent. - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. - Histologically or cytologically confirmed PDAC with metastatic disease. - Measurable disease per RECIST 1.1. - Adequate organ function (bone marrow, liver, kidney, coagulation) - Documented RAS mutation status, either mutant or wild-type. RAS mutations defined as nonsynonymous mutations in KRAS, NRAS, or HRAS at codons 12, 13, or 61 (G12, G13, or Q61). - Able to take oral medications.
Exclusion Criteria
- Prior therapy with direct RAS-targeted therapy (eg. degraders and/or inhibitors). - History of or known central nervous system metastatic disease. - Any conditions that may affect the ability to take or absorb study treatment - Major surgery within 4 weeks prior to randomization. - Patient is unable or unwilling to comply with protocol-required study visits or procedures
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental RMC-6236 |
Study drug |
|
|
Active Comparator Investigator's choice of standard of care therapy |
Patients randomized to Investigator's choice of standard of care chemotherapy will receive one of the following four treatments: - Gemcitabine and nab-paclitaxel (GnP) - Oxaliplatin, leucovorin, irinotecan, and 5-FU (Modified FOLFIRINOX: mFOLFIRINOX) - Liposomal irinotecan (Nal-IRI + 5-FU/LV) - Oxaliplatin, leucovorin and 5-FU IV (FOLFOX) |
|
Recruiting Locations
More Details
- NCT ID
- NCT06625320
- Status
- Active, not recruiting
- Sponsor
- Revolution Medicines, Inc.
Detailed Description
This is a global, randomized, open-label, Phase 3 study designed to evaluate whether treatment with RMC-6236 will improve progression free survival (PFS) or overall survival (OS) compared to Investigator's choice of standard of care chemotherapy in patients with metastatic PDAC who were previously treated with one prior line of therapy with 5-fluorouracil (5-FU) based or gemcitabine-based regimen. Patients will be randomized in a 1:1 ratio to receive RMC-6236 (Arm A) or Investigator's choice of standard of care chemotherapy (Arm B).