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Study of Daraxonrasib and Daraxonrasib + GnP as First-line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma

NCT07491445

RecruitingPhase 3

Sponsor: Revolution Medicines, Inc.

Conditions: Pancreatic Cancer, Pancreatic Cancer Metastatic, PDAC, PDAC - Pancreatic Ductal Adenocarcinoma, Pancreatic Ductal Adenocarcinoma (PDAC)

Interventions: daraxonrasib, gemcitabine, nab-paclitaxel

Countries: United States, Australia, Japan

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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 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.

Locations (25)

Scottsdale, Arizona, United States
Tampa, Florida, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Henderson, Nevada, United States
New York, New York, United States
Cincinnati, Ohio, United States
Maumee, Ohio, United States
Nashville, Tennessee, United States
Dallas, Texas, United States
Houston, Texas, United States
Salt Lake City, Utah, United States
Fairfax, Virginia, United States
Seattle, Washington, United States
Waratah, New South Wales, Australia
Kashiwa, Chiba, Japan
Koto-Ku, Tokyo, Japan
Chiba, Japan
Fukuoka, Japan
Fukuoka, Japan
Kanagawa, Japan
Osaka, Japan
Tokyo, Japan
Wakayama, Japan
Yamaguchi, Japan