Study of Daraxonrasib and Daraxonrasib + GnP as First-line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Purpose
The purpose of this study is to evaluate the safety and efficacy of an investigational RAS(ON) inhibitor administered as monotherapy or in combination with chemotherapy, compared with standard of care (SOC) chemotherapy alone.
Conditions
- Pancreatic Cancer
- Pancreatic Cancer Metastatic
- PDAC
- PDAC - Pancreatic Ductal Adenocarcinoma
- Pancreatic Ductal Adenocarcinoma (PDAC)
- Pancreatic Adenocarcinoma Metastatic
- Pancreatic Adenocarcinoma
- Pancreatic Adenosquamous Carcinoma
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 pancreatic adenocarcinoma. - Diagnosis of metastatic disease ≤ 6 weeks prior to informed consent. - Documented RAS mutation status, either mutant or wild-type. - Measurable disease per RECIST v1.1. - Adequate organ function (bone marrow, liver, kidney, coagulation). - Able to take oral medications.
Exclusion Criteria
- Prior treatment with systemic anticancer therapy in metastatic setting or prior RAS-targeted therapy in any treatment setting. - Active or known history of untreated central nervous system metastatic disease. - 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.
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 Arm A: daraxonrasib |
study drug |
|
|
Experimental Arm B: daraxonrasib + gemcitabine and nab-paclitaxel |
study drug in combination with chemotherapy |
|
|
Active Comparator Arm C: gemcitabine and nab-paclitaxel |
SOC chemotherapy |
|
Recruiting Locations
H Lee Moffitt Cancer Center and Research Institute
Tampa, Florida 33612
Tampa, Florida 33612
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland 21287
Baltimore, Maryland 21287
Dana-Farber Cancer Institute
Boston, Massachusetts 02215
Boston, Massachusetts 02215
Comprehensive Cancer Centers of Nevada
Henderson, Nevada 89052
Henderson, Nevada 89052
Memorial Sloan Kettering Cancer Center
New York, New York 10065
New York, New York 10065
University of Cincinnati Cancer Center
Cincinnati, Ohio 45219
Cincinnati, Ohio 45219
Taylor Cancer Research Center
Maumee, Ohio 43537
Maumee, Ohio 43537
SCRI Oncology Partners
Nashville, Tennessee 37203
Nashville, Tennessee 37203
SCRI - Texas Oncology Dallas
Dallas, Texas 95246
Dallas, Texas 95246
Virginia Cancer Specialists
Fairfax, Virginia 22031
Fairfax, Virginia 22031
Virginia Mason Medical Center
Seattle, Washington 98101
Seattle, Washington 98101
More Details
- Status
- Recruiting
- Sponsor
- Revolution Medicines, Inc.
Detailed Description
This is a global, randomized, open-label, Phase 3 study designed to evaluate whether treatment with daraxonrasib monotherapy or daraxonrasib plus gemcitabine and nab-paclitaxel will improve progression-free survival and/or overall survival compared with standard gemcitabine and nab-paclitaxel when given as first-line treatment in patients with metastatic pancreatic adenocarcinoma. Patients will be randomized to one of three arms: daraxonrasib (Arm A), daraxonrasib + gemcitabine and nab-paclitaxel (Arm B), or gemcitabine and nab-paclitaxel (Arm C).