This Expanded Access Program (EAP) is intended to provide daraxonrasib to eligible adultpatients with previously treated metastatic pancreatic adenocarcinoma, who have nocomparable or satisfactory alternative therapy and are unable to participate in anongoing daraxonrasib clinical trial.
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.
Drug: daraxonrasib
Oral tablets administered once daily
Other Name: RMC-6236,RMC-0706236
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.
Southern Cancer Center
Daphne, Alabama, United States
Southern Cancer Center
Mobile, Alabama, United States
Alaska Oncology and Hematology
Anchorage, Alaska, United States
Mayo Clinic - Arizona
Phoenix, Arizona, United States
Honor Health
Scottsdale, Arizona, United States
University of Arizona Cancer Center
Tucson, Arizona, United States
Mercy Hospital Fort Smith
Fort Smith, Arkansas, United States
Genesis Cancer and Blood Institute
Hot Springs, Arkansas, United States
Care Oncology Center
Chula Vista, California, United States
City of Hope Cancer Center (California)
Duarte, California, United States
USC Norris Comprehensive Cancer Hospital
Los Angeles, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
UCLA Health Westlake Village
Los Angeles, California, United States
University of California
Los Angeles, California, United States
El Camino Health
Mountain View, California, United States
University of California - San Francisco
Oakland, California, United States
UCI Health
Orange, California, United States
Desert Care Network Comprehensive Cancer
Palm Springs, California, United States
The Kaiser Permanente Medical Group
Roseville, California, United States
Sutter Health
Sacramento, California, United States
Sutter Health
San Francisco, California, United States
CommonSpirit
San Luis Obispo, California, United States
Stanford University
Stanford, California, United States
NorthBay Health Heidi Y Campini Cancer Center
Vacaville, California, United States
UCSF John Muir Health
Walnut Creek, California, United States
Rocky Mountain Cancer Center
Aurora, Colorado, United States
AdventHealth Porter
Denver, Colorado, United States
CommonSpirit Oncology Mercy
Durango, Colorado, United States
Lynn Cancer Institute - Boca Raton Regional Hospital
Boca Raton, Florida, United States
Memorial Cancer Institute
Hollywood, Florida, United States
Mayo Clinic - Florida
Jacksonville, Florida, United States
Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Baptist Hospital of Miami
Miami, Florida, United States
Mount Sinai Medical Center of Florida
Miami Beach, Florida, United States
Florida Cancer Specialists and Research Institute
Naples, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Piedmont Physicians Medical Oncology
Atlanta, Georgia, United States
Emory University Hospital
Atlanta, Georgia, United States
Northwest Georgia Oncology Centers
Marietta, Georgia, United States
The Queen's Medical Center
Honolulu, Hawaii, United States
St Luke's Cancer Institute
Boise, Idaho, United States
Illinois Cancer Specialist
Arlington Heights, Illinois, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Advocate Health Care
Downers Grove, Illinois, United States
Endeavor Health Cancer Institute
Naperville, Illinois, United States
OSF Cancer Institute
Peoria, Illinois, United States
University of Iowa Cancer Services Quad Cities
Bettendorf, Iowa, United States
University of Iowa
Waukee, Iowa, United States
Advent Health Shawnee Mission
Merriam, Kansas, United States
University of Kansas Medical Center
Westwood, Kansas, United States
Cancer Center of Kansas
Wichita, Kansas, United States
Baptist Health Lexington
Lexington, Kentucky, United States
Norton Cancer Institute
Louisville, Kentucky, United States
LSU LCMC Health Cancer Center
New Orleans, Louisiana, United States
New England Cancer Specialists
Topsham, Maine, United States
Johns Hopkins
Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Karmanos Cancer Institute (Barbara Ann Karmanos Cancer Hospital)
Detroit, Michigan, United States
Henry Ford Health
Detroit, Michigan, United States
Hematology Oncology Consultants
Royal Oak, Michigan, United States
USOR: Minnesota Oncology Hematology, PA
Edina, Minnesota, United States
Mayo Clinic Minnesota
Rochester, Minnesota, United States
Park Nicollet Specialty Center
Saint Louis Park, Minnesota, United States
Health Partners Oncology
Saint Paul, Minnesota, United States
Jackson Oncology Associates
Jackson, Mississippi, United States
Mercy Hospital Joplin
Joplin, Missouri, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States
Mid America Cancer Care
Kansas City, Missouri, United States
Oncology Hematology Associates
Springfield, Missouri, United States
Mercy Hospital St. Louis-South
St Louis, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Nebraska Cancer Specialists
Omaha, Nebraska, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
MD Anderson at Cooper
Camden, New Jersey, United States
Overlook Medical Center - Medical Diagnostic Associates - Atlantic Medical Group
Morristown, New Jersey, United States
Hirschfeld Oncology
Brooklyn, New York, United States
Northwell Health
Lake Success, New York, United States
Memorial Sloan Kettering Cancer Center
Long Island City, New York, United States
NYU Langone Health
New York, New York, United States
The Mount Sinai Hospital
New York, New York, United States
New York Cancer and Blood Specialists
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Duke Cancer Institute
Durham, North Carolina, United States
Carolina BioOncology Institute
Huntersville, North Carolina, United States
Blood and Cancer Center
Canfield, Ohio, United States
UH Seidman Cancer Centre
Cleveland, Ohio, United States
Zangmeister Cancer Center
Columbus, Ohio, United States
Premier Health OH
Dayton, Ohio, United States
Premier Health OH
Middletown, Ohio, United States
Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma, United States
Compass Oncology
Happy Valley, Oregon, United States
Oregon Oncology Specialists
Salem, Oregon, United States
Willamette Valley Cancer Institute
Springfield, Oregon, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, United States
Allegheny Health Network Cancer Institute
Butler, Pennsylvania, United States
Hematology & Oncology Associates of NEPA
Dunmore, Pennsylvania, United States
Alliance Cancer Specialists
Media, Pennsylvania, United States
Allegheny Valley Hospital
Natrona Heights, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Guthrie Sayre
Sayre, Pennsylvania, United States
Monument Health Cancer Care Institute
Rapid City, South Dakota, United States
Avera Cancer Institute
Sioux Falls, South Dakota, United States
West Cancer Center
Germantown, Tennessee, United States
Sarah Cannon Cancer Institute
Nashville, Tennessee, United States
Tennessee Oncology
Nashville, Tennessee, United States
MD Anderson Cancer Center
Houston, Texas, United States
Methodist Richardson Cancer Center
Richardson, Texas, United States
Utah Cancer Specialists (UCS)
Salt Lake City, Utah, United States
University of Vermont Medical Center
Burlington, Vermont, United States
Virginia Oncology Associates
Hampton, Virginia, United States
Riverside Health
Newport News, Virginia, United States
Virginia Cancer Institute
Richmond, Virginia, United States
Kadlec Regional Medical Center
Kennewick, Washington, United States
Seattle Integrative Cancer Center
Renton, Washington, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Swedish Cancer Institute Treatment Center
Seattle, Washington, United States
Providence St. Mary Medical Center
Walla Walla, Washington, United States
Aurora Medical Center
Grafton, Wisconsin, United States
Marshfield Medical Center
Marshfield, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
UW Health Cancer Center at ProHealth Care
Waukesha, Wisconsin, United States
PanOncology Centre
San Juan, Puerto Rico
Revolution Medicines Study Director
1-844-2-REVMED
medinfo@revmed.com
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