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Purpose

This Expanded Access Program (EAP) is intended to provide daraxonrasib to eligible adult patients with previously treated metastatic pancreatic adenocarcinoma, who have no comparable or satisfactory alternative therapy and are unable to participate in an ongoing daraxonrasib clinical trial.

Conditions

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. - Evidence of active disease progression during or following the most recent line of systemic therapy for PDAC, based on investigator assessment. - At least one prior line of systemic therapy in the metastatic setting, which must include either a fluoropyrimidine-based or gemcitabine-based regimen. - Received and progressed, been intolerant to prior standard therapy, or no longer expected to benefit from standard therapies. - Adequate bone marrow, renal, hepatic, and coagulation functions. - Ineligible for, or unable to enroll in, another clinical trial of daraxonrasib, if available. - Able to take oral medications

Exclusion Criteria

  • History of known central nervous system metastatic disease. - Concurrent systemic anticancer therapy. - Significant cardiovascular disease. - Major GI conditions that may affect the ability to take or absorb daraxonrasib (patients with prior Whipple procedure are eligible). - Active uncontrolled systemic infection. - Major surgery within 28 days before enrollment. - Additional inclusion and exclusion criteria may apply.

Study Design

Phase
Study Type
Expanded Access

Recruiting Locations

Southern Cancer Center
Daphne, Alabama 36526

Southern Cancer Center
Mobile, Alabama 36608

Alaska Oncology and Hematology
Anchorage, Alaska 99508

Honor Health
Scottsdale, Arizona 85258

Care Oncology Center
Chula Vista, California 91911

City of Hope Cancer Center (California)
Duarte, California 91010

USC Norris Comprehensive Cancer Hospital
Los Angeles, California 90033

Cedars-Sinai Medical Center
Los Angeles, California 90048

UCLA Health Westlake Village
Los Angeles, California 90095

University of California
Los Angeles, California 90095

El Camino Health
Mountain View, California 94040

The Kaiser Permanente Medical Group
Roseville, California 95661

Sutter Health
Sacramento, California 95816

Sutter Health
San Francisco, California 94115

NorthBay Health Heidi Y Campini Cancer Center
Vacaville, California 95687

UCSF John Muir Health
Walnut Creek, California 94598

Rocky Mountain Cancer Center
Aurora, Colorado 80012

CommonSpirit Oncology Mercy
Durango, Colorado 81301

Lynn Cancer Institute - Boca Raton Regional Hospital
Boca Raton, Florida 33487

Memorial Cancer Institute
Hollywood, Florida 33021

Mayo Clinic - Florida
Jacksonville, Florida 32224

Sylvester Comprehensive Cancer Center
Miami, Florida 33136

Baptist Hospital of Miami
Miami, Florida 33176

Mount Sinai Medical Center of Florida
Miami Beach, Florida 33140

Moffitt Cancer Center
Tampa, Florida 33612

The Queen's Medical Center
Honolulu, Hawaii 96813

Illinois Cancer Specialist
Arlington Heights, Illinois 60005

University of Iowa
Waukee, Iowa 50263

Advent Health Shawnee Mission
Merriam, Kansas 66204

University of Kansas Medical Center
Westwood, Kansas 66205

Cancer Center of Kansas
Wichita, Kansas 67214

Baptist Health Lexington
Lexington, Kentucky 40503

LSU LCMC Health Cancer Center
New Orleans, Louisiana 70112

New England Cancer Specialists
Topsham, Maine 04086

Johns Hopkins
Baltimore, Maryland 21231

Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215

Dana Farber Cancer Institute
Boston, Massachusetts 02215

University of Michigan
Ann Arbor, Michigan 48109

Karmanos Cancer Institute (Barbara Ann Karmanos Cancer Hospital)
Detroit, Michigan 48201

Henry Ford Health
Detroit, Michigan 48202

Mayo Clinic Minnesota
Rochester, Minnesota 55905

Park Nicollet Specialty Center
Saint Louis Park, Minnesota 55426

Health Partners Oncology
Saint Paul, Minnesota 55101

Saint Luke's Hospital of Kansas City
Kansas City, Missouri 64111

Mid America Cancer Care
Kansas City, Missouri 64132

Washington University School of Medicine
St Louis, Missouri 63141

Nebraska Cancer Specialists
Omaha, Nebraska 68130

Overlook Medical Center - Medical Diagnostic Associates - Atlantic Medical Group
Morristown, New Jersey 07960

Hirschfeld Oncology
Brooklyn, New York 11206

Memorial Sloan Kettering Cancer Center
Long Island City, New York 11101

NYU Langone Health
New York, New York 10016

The Mount Sinai Hospital
New York, New York 10029

Montefiore Medical Center
The Bronx, New York 10461

Duke Cancer Institute
Durham, North Carolina 27710

Carolina BioOncology Institute
Huntersville, North Carolina 28078

Zangmeister Cancer Center
Columbus, Ohio 43219

Premier Health OH
Dayton, Ohio 45459

Premier Health OH
Middletown, Ohio 45005

Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma 73120

Oregon Oncology Specialists
Salem, Oregon 97301

Hematology & Oncology Associates of NEPA
Dunmore, Pennsylvania 18512

Thomas Jefferson University Hospital
Philadelphia, Pennsylvania 19107

Guthrie Sayre
Sayre, Pennsylvania 18840

Avera Cancer Institute
Sioux Falls, South Dakota 57105

West Cancer Center
Germantown, Tennessee 38138

Sarah Cannon Cancer Institute
Nashville, Tennessee 37203

MD Anderson Cancer Center
Houston, Texas 77030

Seattle Integrative Cancer Center
Renton, Washington 98057

Virginia Mason Medical Center
Seattle, Washington 98101

Swedish Cancer Institute Treatment Center
Seattle, Washington 98104

Marshfield Medical Center
Marshfield, Wisconsin 54449

Medical College of Wisconsin
Milwaukee, Wisconsin 53226

PanOncology Centre
San Juan, Puerto Rico 00909

More Details

Status
Available
Sponsor
Revolution Medicines, Inc.

Study Contact

Revolution Medicines Study Director
1-844-2-REVMED
medinfo@revmed.com

Detailed Description

This EAP has been established to provide access to daraxonrasib to patients with previously treated metastatic pancreatic adenocarcinoma during the period before potential commercial availability. Patients may be eligible if they have progressed on, are intolerant of, or are no longer expected to benefit from available standard therapies, and if they are not able to enroll in a clinical trial of daraxonrasib due to ineligibility or lack of access. This EAP is intended to address an unmet medical need and is not designed to support clinical development objectives. Daraxonrasib is an investigational, orally administered, RAS(ON) inhibitor administered as monotherapy. Daraxonrasib will be supplied by the Sponsor free of charge during the duration of treatment under this program.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.