Print

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

Alabama Oncology
Birmingham, Alabama 35243

Southern Cancer Center
Daphne, Alabama 36526

Dothan Hematology and Oncology
Dothan, Alabama 36303

Alabama Cancer Care of Ft Payne
Fort Payne, Alabama 35967

USA Health Mitchell Cancer Institute
Mobile, Alabama 36604

Southern Cancer Center
Mobile, Alabama 36608

Montgomery Cancer Center
Montgomery, Alabama 36106

Alabama Cancer Care of Tuscaloosa
Tuscaloosa, Alabama 35406

Alaska Oncology and Hematology
Anchorage, Alaska 99508

Cancer and Blood Specialists of Arizona
Casa Grande, Arizona 85122

City of Hope Phoenix
Goodyear, Arizona 85338

Mayo Clinic - Arizona
Phoenix, Arizona 85054

Honor Health
Scottsdale, Arizona 85258

University of Arizona Cancer Center
Tucson, Arizona 85719

Mercy Hospital Fort Smith
Fort Smith, Arkansas 72903

Genesis Cancer and Blood Institute
Hot Springs, Arkansas 71913

Carti Cancer Center
Little Rock, Arkansas 72205

Care Oncology Center
Chula Vista, California 91911

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

Cancer and Blood Specialty Clinics
Fountain Valley, California 92708

California Cancer Associates for Research and Excellence
Fresno, California 93720

Providence St. Jude
Fullerton, California 92835

Marin Cancer Care
Greenbrae, California 94904

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

Pacific Cancer Care
Monterey, California 93940

El Camino Health
Mountain View, California 94040

University of California - San Francisco
Oakland, California 94158

UCI Health
Orange, California 92612

Desert Care Network Comprehensive Cancer
Palm Springs, California 92262

The Kaiser Permanente Medical Group
Roseville, California 95661

Sutter Health
Sacramento, California 95816

Scripps Clinic Torrey Pines
San Diego, California 92037

Sutter Health
San Francisco, California 94115

Bakar Precision Cancer Medicine Building
San Francisco, California 94143

CommonSpirit
San Luis Obispo, California 93401

Providence Medical Foundation
Santa Rosa, California 95403

Stanford University
Stanford, California 94305

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

UC Health Memorial Health System
Colorado Springs, Colorado 80920

AdventHealth Porter
Denver, Colorado 80210

Intermountain Health
Denver, Colorado 80211

CommonSpirit Oncology Mercy
Durango, Colorado 81301

UCHealth Poudre Valley Hospital
Fort Collins, Colorado 80528

Yale New Haven Hospital
New Haven, Connecticut 06519

Norwalk Hospital
Norwalk, Connecticut 06856

Eastern Connecticut Hematology and Oncology
Norwich, Connecticut 06360

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

Advanced Cancer Treatment Centers
Brooksville, Florida 36413

Memorial Cancer Institute
Hollywood, Florida 33021

Mayo Clinic - Florida
Jacksonville, Florida 32224

Cancer Specialists of North Florida
Jacksonville, Florida 32256

Sylvester Comprehensive Cancer Center
Miami, Florida 33136

Baptist Hospital of Miami
Miami, Florida 33176

Mount Sinai Medical Center of Florida
Miami Beach, Florida 33140

Florida Cancer Specialists and Research Institute
Naples, Florida 32746

Advent Health
Orlando, Florida 32803

Holy Cross Health - Phil Smith Neuroscience Institute ALS Multidisciplinary Clinic
Orlando, Florida 33308

Ascension Sacred Heart
Pensacola, Florida 32504

Intercoastal Medical Group
Sarasota, Florida 34232

Tampa General Hospital
Tampa, Florida 33606

Moffitt Cancer Center
Tampa, Florida 33612

Piedmont Cancer Institute - Atlanta
Atlanta, Georgia 30318

Piedmont Physicians Medical Oncology
Atlanta, Georgia 30318

Emory University Hospital
Atlanta, Georgia 30322

North Side Hospital - Atlanta Cancer Care
Atlanta, Georgia 30342

Piedmont Columbus Regional Midtown
Columbus, Georgia 31904

Central Georgia Cancer Care
Macon, Georgia 31210

Northwest Georgia Oncology Centers
Marietta, Georgia 30060

The Queen's Medical Center
Honolulu, Hawaii 96813

Hawai'i Pacific Health
Honolulu, Hawaii 96814

St Luke's Cancer Institute
Boise, Idaho 83712

Beacon Clinic
Post Falls, Idaho 83854

Illinois Cancer Specialist
Arlington Heights, Illinois 60005

Northwestern University
Chicago, Illinois 60611

University of Chicago Medical Center
Chicago, Illinois 60637

Advocate Health Care
Downers Grove, Illinois 60515

Endeavor Health Cancer Institute
Naperville, Illinois 60126

Illinois CancerCare
Peoria, Illinois 61615

OSF Cancer Institute
Peoria, Illinois 61637

Blessing Hospital
Quincy, Illinois 62301

Northwest Oncology & Hematology
Rolling Meadows, Illinois 60008

City of Hope Chicago
Zion, Illinois 60099

Parkview Packnett Family Cancer Institute
Fort Wayne, Indiana 46845

Indiana University School of Medicine
Indianapolis, Indiana 46202

Franciscan Alliance Health
Indianapolis, Indiana 46237

Ascension Medical Group St. Vincent
Newburgh, Indiana 47630

Deaconess Health System
Newburgh, Indiana 47630

McFarland Clinic
Ames, Iowa 50010

University of Iowa Cancer Services Quad Cities
Bettendorf, Iowa 52722

Mercy Medical Center
Cedar Rapids, Iowa 52403

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

St. Elizabeth Healthcare
Edgewood, Kentucky 41017

Baptist Health Lexington
Lexington, Kentucky 40503

Norton Cancer Institute
Louisville, Kentucky 40217

Owensboro Health Mitchell Memorial Cancer Center
Owensboro, Kentucky 42303

Mercy Health - Paducah Cancer Center
Paducah, Kentucky 42003

LSU LCMC Health Cancer Center
New Orleans, Louisiana 70112

Ochsner Health System
New Orleans, Louisiana 70121

Willis Knighton Cancer Center
Shreveport, Louisiana 71103

New England Cancer Specialists
Topsham, Maine 04086

Johns Hopkins
Baltimore, Maryland 21231

Frederick Health
Frederick, Maryland 21701

Massachusetts General Hospital
Boston, Massachusetts 02114

Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215

Dana Farber Cancer Institute
Boston, Massachusetts 02215

Lahey Clinic
Burlington, Massachusetts 01805

Mountain Health Clinic
Natick, Massachusetts 01760

UMass Memorial Medical Center
Worcester, Massachusetts 01655

University of Michigan
Ann Arbor, Michigan 48109

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

Henry Ford Health
Detroit, Michigan 48202

The Cancer & Hematology Centers
Grand Rapids, Michigan 49546

Hematology Oncology Consultants
Royal Oak, Michigan 48073

Covenant HealthCare
Saginaw, Michigan 48604

Trinity Health Hospital
Ypsilanti, Michigan 48197

Essentia Health
Duluth, Minnesota 55805

USOR: Minnesota Oncology Hematology, PA
Edina, Minnesota 55435

Mayo Clinic Minnesota
Rochester, Minnesota 55905

Health Partners Frauenshuh Cancer Center
Saint Louis Park, Minnesota 55426

HealthPartners Frauenshuh Cancer Center
Saint Louis Park, Minnesota 55426

Park Nicollet Specialty Center
Saint Louis Park, Minnesota 55426

Health Partners Oncology
Saint Paul, Minnesota 55101

Jackson Oncology Associates
Jackson, Mississippi 39202

University Hospital - MU Health Care
Columbia, Missouri 65212

Mercy Hospital Joplin
Joplin, Missouri 64804

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

Mid America Cancer Care
Kansas City, Missouri 64132

Mercy Hospital Springfield
Springfield, Missouri 65807

Oncology Hematology Associates
Springfield, Missouri 65807

Mercy Hospital St. Louis-South
St Louis, Missouri 63128

Pratt Cancer Center
St Louis, Missouri 63141

Washington University School of Medicine
St Louis, Missouri 63141

Logan Health
Kalispell, Montana 59901

NHO Revive Research Institute
Lincoln, Nebraska 68506

University of Nebraska Medical Center
Omaha, Nebraska 68114

Nebraska Cancer Specialists
Omaha, Nebraska 68130

Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire 03756

MD Anderson at Cooper
Camden, New Jersey 08103

Summit Health
Florham Park, New Jersey 07932

Lindenberg Cancer & Hematology Center
Marlton, New Jersey 08053

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

Rutgers Cancer Institute
New Brunswick, New Jersey 08903

Community Medical Center
Toms River, New Jersey 08755

New York Oncology Hematology
Albany, New York 12206

Hirschfeld Oncology
Brooklyn, New York 11206

Dosik Hematology and Oncology
Brooklyn, New York 11215

Northwell Health
Lake Success, New York 11042

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

NYU Langone Health
New York, New York 10016

Columbia University
New York, New York 10022

The Mount Sinai Hospital
New York, New York 10029

Columbia University Irving Medical Center
New York, New York 10032

New York Cancer and Blood Specialists
New York, New York 11967

Rochester Regional Health
Rochester, New York 14626

Stony Brook University Hospital
Stony Brook, New York 11794

Montefiore Medical Center
The Bronx, New York 10461

Atrium Health
Charlotte, North Carolina 28204

Duke Cancer Institute
Durham, North Carolina 27710

Carolina BioOncology Institute
Huntersville, North Carolina 28078

Wake Forest University Health Sciences
Winston-Salem, North Carolina 27157

Sanford Roger Maris Cancer Center
Fargo, North Dakota 58102

Blood and Cancer Center
Canfield, Ohio 44406

Aultman Hospital
Canton, Ohio 44170

OHC (Oncology Hematology Care)
Cincinnati, Ohio 45242

UH Seidman Cancer Centre
Cleveland, Ohio 44106

University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106

Cleveland Clinic Foundation
Cleveland, Ohio 95000

Jasonway Cancer Center
Columbus, Ohio 43214

Ohio Health
Columbus, Ohio 43214

OhioHealth Mansfield Hospital
Columbus, Ohio 43214

Zangmeister Cancer Center
Columbus, Ohio 43219

The Ohio State University Wexner Medical Center
Columbus, Ohio 43221

Premier Health OH
Dayton, Ohio 45459

Kettering Health Cancer Center
Kettering, Ohio 45429

Premier Health OH
Middletown, Ohio 45005

OU Health Science Center - Stephenson Cancer Center
Oklahoma City, Oklahoma 73104

Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma 73120

Samaritan Hemotology and Oncology
Corvallis, Oregon 97330

Compass Oncology
Happy Valley, Oregon 97223

Providence Medical Center
Portland, Oregon 97213

Oregon Oncology Specialists
Salem, Oregon 97301

Willamette Valley Cancer Institute
Springfield, Oregon 97477

Lehigh Valley Hospital
Allentown, Pennsylvania 18103

St. Luke's University Health Network
Bethlehem, Pennsylvania 18015

Bryn Mawr Hospital
Bryn Mawr, Pennsylvania 19010

Allegheny Health Network Cancer Institute
Butler, Pennsylvania 15212

Hematology & Oncology Associates of NEPA
Dunmore, Pennsylvania 18512

Alliance Cancer Specialists
Media, Pennsylvania 19063

Allegheny Valley Hospital
Natrona Heights, Pennsylvania 15212

Paoli Hospital
Paoli, Pennsylvania 19301

University of Pennsylvania
Philadelphia, Pennsylvania 19104

Thomas Jefferson University Hospital
Philadelphia, Pennsylvania 19107

Fox Chase Cancer Center
Philadelphia, Pennsylvania 19111

University of Pittsburgh Medical Center (UPMC)
Pittsburgh, Pennsylvania 15224

UPMC Western Maryland
Pittsburgh, Pennsylvania 15224

Guthrie Sayre
Sayre, Pennsylvania 18840

UPMC Hillman Cancer Center
West Mifflin, Pennsylvania 15122

Lankenau Medical Center
Wynnewood, Pennsylvania 19096

Rhode Island Hospital
Providence, Rhode Island 02903

Bon Secours St. Francis Cancer Center
Charleston, South Carolina 29414

McLeod Health
Florence, South Carolina 29506

Spartanburg Regional Healthcare System - Gibbs Cancer Center & Research Institute
Greer, South Carolina 29651

Monument Health Cancer Care Institute
Rapid City, South Dakota 57701

Sanford Health
Sioux Falls, South Dakota 57104

Avera Cancer Institute
Sioux Falls, South Dakota 57105

West Cancer Center
Germantown, Tennessee 38138

Tennessee Cancer Specialists
Knoxville, Tennessee 37919

Baptist Cancer Center
Memphis, Tennessee 38120

Sarah Cannon Cancer Institute
Nashville, Tennessee 37203

Tennessee Oncology
Nashville, Tennessee 37203

University of Texas Southwestern Medical
Dallas, Texas 75390

DHR Health
Edinburg, Texas 78539

William Beaumont Army Medical Center - Fort Bliss
Fort Bliss, Texas 79918

American Oncology Network - Oncology Consultants
Houston, Texas 77024

Houston Methodist Hospital- Cancer Center
Houston, Texas 77030

MD Anderson Cancer Center
Houston, Texas 77030

Covenant Health - Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas 79410

Texas Oncology
Pearland, Texas 77584

Methodist Richardson Cancer Center
Richardson, Texas 75082

UT Health San Antonio MD Anderson Cancer Center
San Antonio, Texas 78229

Baylor Scott & White Health
Temple, Texas 76508

Ogden Clinic
Ogden, Utah 84405

Utah Cancer Specialists (UCS)
Salt Lake City, Utah 84106

Huntsman Cancer Institute & Hospital
Salt Lake City, Utah 84112

University of Vermont Medical Center
Burlington, Vermont 05401

Inova Schar Cancer
Fairfax, Virginia 22031

Virginia Cancer Specialists
Fairfax, Virginia 22031

Hematology Oncology Associates of Fredericksburg
Fredericksburg, Virginia 22408

Virginia Oncology Associates
Hampton, Virginia 23606

Riverside Health
Newport News, Virginia 23320

VCU Health
Richmond, Virginia 23219

Virginia Cancer Institute
Richmond, Virginia 23229

Kadlec Regional Medical Center
Kennewick, Washington 99336

Seattle Integrative Cancer Center
Renton, Washington 98057

Virginia Mason Medical Center
Seattle, Washington 98101

Providence Swedish Cancer Institute
Seattle, Washington 98104

Swedish Cancer Institute Treatment Center
Seattle, Washington 98104

Fred Hutch Cancer Center
Seattle, Washington 98109

Providence St. Mary Medical Center
Walla Walla, Washington 99362

ThedaCare Regional Cancer Center
Appleton, Wisconsin 54611

Aurora Medical Center
Grafton, Wisconsin 53024

HSHS St. Mary's Hospital Medical Center
Green Bay, Wisconsin 54303

Bellin Health
Green Bay, Wisconsin 54313

Emplify Health by Gundersen
La Crosse, Wisconsin 05461

University of Wisconsin
Madison, Wisconsin 53792

Marshfield Medical Center
Marshfield, Wisconsin 54449

Medical College of Wisconsin
Milwaukee, Wisconsin 53226

UW Health Cancer Center at ProHealth Care
Waukesha, Wisconsin 53072

PanOncology Centre
San Juan, Puerto Rico 00909

More Details

NCT ID
NCT07573215
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.