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
Banner MD Anderson Cancer Center
Gilbert, Arizona 85234
Gilbert, Arizona 85234
Mayo Clinic
Phoenix, Arizona 85054
Phoenix, Arizona 85054
Contact:
Dr. Mitesh Borad
Dr. Mitesh Borad
Cedars-Sinai Medical Center
Los Angeles, California 90048
Los Angeles, California 90048
UC San Diego Health Moores Cancer Center
San Diego, California 92037
San Diego, California 92037
Mission Hall UCSF
San Francisco, California 94158
San Francisco, California 94158
Mayo Clinic Cancer Center
Jacksonville, Florida 32224
Jacksonville, Florida 32224
Contact:
Dr. Hani Babiker
855-776-0015
Dr. Hani Babiker
855-776-0015
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida 33136
Miami, Florida 33136
Cancer Care Centers of Brevard Inc
Palm Bay, Florida 32909
Palm Bay, Florida 32909
The University of Chicago Medical Center
Chicago, Illinois 60637
Chicago, Illinois 60637
Johns Hopkins
Baltimore, Maryland 21287
Baltimore, Maryland 21287
Dana Farber Cancer Institute
Boston, Massachusetts 02215
Boston, Massachusetts 02215
Karmanos Cancer Institute
Detroit, Michigan 48201
Detroit, Michigan 48201
Mayo Clinic Rochester
Rochester, Minnesota 55905
Rochester, Minnesota 55905
Contact:
Dr. Ryan Carr
855-776-0015
Dr. Ryan Carr
855-776-0015
Washington University
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
Roswell Park Cancer Institute
Buffalo, New York 14263
Buffalo, New York 14263
Memorial Sloan Kettering Cancer Center
New York, New York 10022
New York, New York 10022
Columbia University Medical Center
New York, New York 10032
New York, New York 10032
Duke University Medical Center
Durham, North Carolina 27710
Durham, North Carolina 27710
University of Cincinnati Medical Center
Cincinnati, Ohio 45219
Cincinnati, Ohio 45219
Stephenson Cancer Center
Oklahoma City, Oklahoma 73104
Oklahoma City, Oklahoma 73104
Abramson Cancer Center Clinical Research Unit
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
Sarah Cannon Research Institute (Tennessee)
Nashville, Tennessee 37203
Nashville, Tennessee 37203
Contact:
Sarah Rector
Sarah Rector
Texas Oncology Sammons
Dallas, Texas 75246
Dallas, Texas 75246
MD Anderson Cancer Center
Houston, Texas 77030
Houston, Texas 77030
Texas Oncology - Central South
Irving, Texas 75063
Irving, Texas 75063
Huntsman Cancer Institute
Salt Lake City, Utah 84112
Salt Lake City, Utah 84112
Virginia Cancer Specialists
Fairfax, Virginia 22031
Fairfax, Virginia 22031
Pan-American Center for Oncology Trials
San Juan, Puerto Rico 00907
San Juan, Puerto Rico 00907
More Details
- NCT ID
- NCT06625320
- Status
- 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).