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Study of Daraxonrasib (RMC-6236) in Patients With Resected Pancreatic Ductal Adenocarcinoma (PDAC)

RecruitingPhase 3

Sponsor: Revolution Medicines, Inc.

Conditions: Pancreatic Cancer, PDAC, PDAC - Pancreatic Ductal Adenocarcinoma, Resectable Pancreatic Ductal Adenocarcinoma (PDAC), Resected Pancreatic Adenocarcinoma

Interventions: daraxonrasib

Countries: United States, France, Germany, Italy, Japan, Puerto Rico, South Korea, Spain

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.

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 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.

Locations (60)

Phoenix, Arizona, United States
La Jolla, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Palo Alto, California, United States
San Francisco, California, United States
Lakewood, Colorado, United States
Hartford, Connecticut, United States
Jacksonville, Florida, United States
Miami, Florida, United States
St. Petersburg, Florida, United States
Atlanta, Georgia, United States
Indianapolis, Indiana, United States
Lawrence, Kansas, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Rochester, Minnesota, United States
Kansas City, Missouri, United States
Omaha, Nebraska, United States
Las Vegas, Nevada, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
Durham, North Carolina, United States
Maumee, Ohio, United States
Sioux Falls, South Dakota, United States
Nashville, Tennessee, United States
Dallas, Texas, United States
Houston, Texas, United States
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