Expanded Access Program for Daraxonrasib (RMC-6236) in Previously Treated Metastatic Pancreatic Adenocarcinoma
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
- PDAC
- PDAC - Pancreatic Ductal Adenocarcinoma
- Metastatic Pancreas Adenocarcinoma
- Pancreatic Cancer
- Pancreatic Cancer Metastatic
- Pancreatic Adenocarcinoma Metastatic
- Pancreatic Adenocarcinoma
- Pancreatic Adenosquamous Carcinoma
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
Daphne, Alabama 36526
Southern Cancer Center
Mobile, Alabama 36608
Mobile, Alabama 36608
Alaska Oncology and Hematology
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Cancer and Blood Specialists of Arizona
Casa Grande, Arizona 85122
Casa Grande, Arizona 85122
Mayo Clinic - Arizona
Phoenix, Arizona 85054
Phoenix, Arizona 85054
Honor Health
Scottsdale, Arizona 85258
Scottsdale, Arizona 85258
University of Arizona Cancer Center
Tucson, Arizona 85719
Tucson, Arizona 85719
Mercy Hospital Fort Smith
Fort Smith, Arkansas 72903
Fort Smith, Arkansas 72903
Genesis Cancer and Blood Institute
Hot Springs, Arkansas 71913
Hot Springs, Arkansas 71913
Care Oncology Center
Chula Vista, California 91911
Chula Vista, California 91911
City of Hope Cancer Center (California)
Duarte, California 91010
Duarte, California 91010
Cancer and Blood Specialty Clinics
Fountain Valley, California 92708
Fountain Valley, California 92708
California Cancer Associates for Research and Excellence
Fresno, California 93720
Fresno, California 93720
USC Norris Comprehensive Cancer Hospital
Los Angeles, California 90033
Los Angeles, California 90033
Cedars-Sinai Medical Center
Los Angeles, California 90048
Los Angeles, California 90048
UCLA Health Westlake Village
Los Angeles, California 90095
Los Angeles, California 90095
University of California
Los Angeles, California 90095
Los Angeles, California 90095
El Camino Health
Mountain View, California 94040
Mountain View, California 94040
University of California - San Francisco
Oakland, California 94158
Oakland, California 94158
UCI Health
Orange, California 92612
Orange, California 92612
Desert Care Network Comprehensive Cancer
Palm Springs, California 92262
Palm Springs, California 92262
The Kaiser Permanente Medical Group
Roseville, California 95661
Roseville, California 95661
Sutter Health
Sacramento, California 95816
Sacramento, California 95816
Sutter Health
San Francisco, California 94115
San Francisco, California 94115
CommonSpirit
San Luis Obispo, California 93401
San Luis Obispo, California 93401
Stanford University
Stanford, California 94305
Stanford, California 94305
NorthBay Health Heidi Y Campini Cancer Center
Vacaville, California 95687
Vacaville, California 95687
UCSF John Muir Health
Walnut Creek, California 94598
Walnut Creek, California 94598
Rocky Mountain Cancer Center
Aurora, Colorado 80012
Aurora, Colorado 80012
AdventHealth Porter
Denver, Colorado 80210
Denver, Colorado 80210
Intermountain Health
Denver, Colorado 80211
Denver, Colorado 80211
CommonSpirit Oncology Mercy
Durango, Colorado 81301
Durango, Colorado 81301
UC Health Poudre Valley Hospital
Fort Collins, Colorado 80528
Fort Collins, Colorado 80528
Yale New Haven Hospital
New Haven, Connecticut 06519
New Haven, Connecticut 06519
Lynn Cancer Institute - Boca Raton Regional Hospital
Boca Raton, Florida 33487
Boca Raton, Florida 33487
Memorial Cancer Institute
Hollywood, Florida 33021
Hollywood, Florida 33021
Mayo Clinic - Florida
Jacksonville, Florida 32224
Jacksonville, Florida 32224
Sylvester Comprehensive Cancer Center
Miami, Florida 33136
Miami, Florida 33136
Baptist Hospital of Miami
Miami, Florida 33176
Miami, Florida 33176
Mount Sinai Medical Center of Florida
Miami Beach, Florida 33140
Miami Beach, Florida 33140
Florida Cancer Specialists and Research Institute
Naples, Florida 32746
Naples, Florida 32746
Advent Health
Orlando, Florida 32803
Orlando, Florida 32803
Holy Cross Health - Phil Smith Neuroscience Institute ALS Multidisciplinary Clinic
Orlando, Florida 33308
Orlando, Florida 33308
Moffitt Cancer Center
Tampa, Florida 33612
Tampa, Florida 33612
Piedmont Physicians Medical Oncology
Atlanta, Georgia 30318
Atlanta, Georgia 30318
Emory University Hospital
Atlanta, Georgia 30322
Atlanta, Georgia 30322
Piedmont Columbus Regional Midtown
Columbus, Georgia 31904
Columbus, Georgia 31904
Northwest Georgia Oncology Centers
Marietta, Georgia 30060
Marietta, Georgia 30060
The Queen's Medical Center
Honolulu, Hawaii 96813
Honolulu, Hawaii 96813
St Luke's Cancer Institute
Boise, Idaho 83712
Boise, Idaho 83712
Illinois Cancer Specialist
Arlington Heights, Illinois 60005
Arlington Heights, Illinois 60005
University of Chicago Medical Center
Chicago, Illinois 60637
Chicago, Illinois 60637
Advocate Health Care
Downers Grove, Illinois 60515
Downers Grove, Illinois 60515
Endeavor Health Cancer Institute
Naperville, Illinois 60126
Naperville, Illinois 60126
OSF Cancer Institute
Peoria, Illinois 61637
Peoria, Illinois 61637
Blessing Hospital
Quincy, Illinois 62301
Quincy, Illinois 62301
Northwest Oncology & Hematology
Rolling Meadows, Illinois 60008
Rolling Meadows, Illinois 60008
City of Hope Chicago
Zion, Illinois 60099
Zion, Illinois 60099
Indiana University School of Medicine
Indianapolis, Indiana 46202
Indianapolis, Indiana 46202
Deaconess Health System
Newburgh, Indiana 47630
Newburgh, Indiana 47630
McFarland Clinic
Ames, Iowa 50010
Ames, Iowa 50010
University of Iowa Cancer Services Quad Cities
Bettendorf, Iowa 52722
Bettendorf, Iowa 52722
University of Iowa
Waukee, Iowa 50263
Waukee, Iowa 50263
Advent Health Shawnee Mission
Merriam, Kansas 66204
Merriam, Kansas 66204
University of Kansas Medical Center
Westwood, Kansas 66205
Westwood, Kansas 66205
Cancer Center of Kansas
Wichita, Kansas 67214
Wichita, Kansas 67214
St. Elizabeth Healthcare
Edgewood, Kentucky 41017
Edgewood, Kentucky 41017
Baptist Health Lexington
Lexington, Kentucky 40503
Lexington, Kentucky 40503
Norton Cancer Institute
Louisville, Kentucky 40217
Louisville, Kentucky 40217
Owensboro Health Mitchell Memorial Cancer Center
Owensboro, Kentucky 42303
Owensboro, Kentucky 42303
LSU LCMC Health Cancer Center
New Orleans, Louisiana 70112
New Orleans, Louisiana 70112
New England Cancer Specialists
Topsham, Maine 04086
Topsham, Maine 04086
Johns Hopkins
Baltimore, Maryland 21231
Baltimore, Maryland 21231
Massachusetts General Hospital
Boston, Massachusetts 02114
Boston, Massachusetts 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
Boston, Massachusetts 02215
Dana Farber Cancer Institute
Boston, Massachusetts 02215
Boston, Massachusetts 02215
Mountain Health Clinic
Natick, Massachusetts 01760
Natick, Massachusetts 01760
University of Michigan
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
Karmanos Cancer Institute (Barbara Ann Karmanos Cancer Hospital)
Detroit, Michigan 48201
Detroit, Michigan 48201
Henry Ford Health
Detroit, Michigan 48202
Detroit, Michigan 48202
The Cancer & Hematology Centers
Grand Rapids, Michigan 49546
Grand Rapids, Michigan 49546
Hematology Oncology Consultants
Royal Oak, Michigan 48073
Royal Oak, Michigan 48073
Trinity Health Hospital
Ypsilanti, Michigan 48197
Ypsilanti, Michigan 48197
USOR: Minnesota Oncology Hematology, PA
Edina, Minnesota 55435
Edina, Minnesota 55435
Mayo Clinic Minnesota
Rochester, Minnesota 55905
Rochester, Minnesota 55905
Health Partners Frauenshuh Cancer Center
Saint Louis Park, Minnesota 55426
Saint Louis Park, Minnesota 55426
Park Nicollet Specialty Center
Saint Louis Park, Minnesota 55426
Saint Louis Park, Minnesota 55426
Health Partners Oncology
Saint Paul, Minnesota 55101
Saint Paul, Minnesota 55101
Jackson Oncology Associates
Jackson, Mississippi 39202
Jackson, Mississippi 39202
Mercy Hospital Joplin
Joplin, Missouri 64804
Joplin, Missouri 64804
Saint Luke's Hospital of Kansas City
Kansas City, Missouri 64111
Kansas City, Missouri 64111
Mid America Cancer Care
Kansas City, Missouri 64132
Kansas City, Missouri 64132
Oncology Hematology Associates
Springfield, Missouri 65807
Springfield, Missouri 65807
Mercy Hospital St. Louis-South
St Louis, Missouri 63128
St Louis, Missouri 63128
Pratt Cancer Center
St Louis, Missouri 63141
St Louis, Missouri 63141
Washington University School of Medicine
St Louis, Missouri 63141
St Louis, Missouri 63141
NHO Revive Research Institute
Lincoln, Nebraska 68506
Lincoln, Nebraska 68506
University of Nebraska Medical Center
Omaha, Nebraska 68114
Omaha, Nebraska 68114
Nebraska Cancer Specialists
Omaha, Nebraska 68130
Omaha, Nebraska 68130
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire 03756
Lebanon, New Hampshire 03756
MD Anderson at Cooper
Camden, New Jersey 08103
Camden, New Jersey 08103
Overlook Medical Center - Medical Diagnostic Associates - Atlantic Medical Group
Morristown, New Jersey 07960
Morristown, New Jersey 07960
Rutgers Cancer Institute
New Brunswick, New Jersey 08903
New Brunswick, New Jersey 08903
Hirschfeld Oncology
Brooklyn, New York 11206
Brooklyn, New York 11206
Northwell Health
Lake Success, New York 11042
Lake Success, New York 11042
Memorial Sloan Kettering Cancer Center
Long Island City, New York 11101
Long Island City, New York 11101
NYU Langone Health
New York, New York 10016
New York, New York 10016
Columbia University
New York, New York 10022
New York, New York 10022
The Mount Sinai Hospital
New York, New York 10029
New York, New York 10029
New York Cancer and Blood Specialists
New York, New York 11967
New York, New York 11967
Rochester Regional Health
Rochester, New York 14626
Rochester, New York 14626
Montefiore Medical Center
The Bronx, New York 10461
The Bronx, New York 10461
Duke Cancer Institute
Durham, North Carolina 27710
Durham, North Carolina 27710
Carolina BioOncology Institute
Huntersville, North Carolina 28078
Huntersville, North Carolina 28078
Blood and Cancer Center
Canfield, Ohio 44406
Canfield, Ohio 44406
UH Seidman Cancer Centre
Cleveland, Ohio 44106
Cleveland, Ohio 44106
Ohio Health
Columbus, Ohio 43214
Columbus, Ohio 43214
Zangmeister Cancer Center
Columbus, Ohio 43219
Columbus, Ohio 43219
The Ohio State University Wexner Medical Center
Columbus, Ohio 43221
Columbus, Ohio 43221
Premier Health OH
Dayton, Ohio 45459
Dayton, Ohio 45459
Premier Health OH
Middletown, Ohio 45005
Middletown, Ohio 45005
Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma 73120
Oklahoma City, Oklahoma 73120
Compass Oncology
Happy Valley, Oregon 97223
Happy Valley, Oregon 97223
Providence Medical Center
Portland, Oregon 97213
Portland, Oregon 97213
Oregon Oncology Specialists
Salem, Oregon 97301
Salem, Oregon 97301
Willamette Valley Cancer Institute
Springfield, Oregon 97477
Springfield, Oregon 97477
Lehigh Valley Hospital
Allentown, Pennsylvania 18103
Allentown, Pennsylvania 18103
Allegheny Health Network Cancer Institute
Butler, Pennsylvania 15212
Butler, Pennsylvania 15212
Hematology & Oncology Associates of NEPA
Dunmore, Pennsylvania 18512
Dunmore, Pennsylvania 18512
Alliance Cancer Specialists
Media, Pennsylvania 19063
Media, Pennsylvania 19063
Allegheny Valley Hospital
Natrona Heights, Pennsylvania 15212
Natrona Heights, Pennsylvania 15212
University of Pennsylvania
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania 19107
Philadelphia, Pennsylvania 19107
Fox Chase Cancer Center
Philadelphia, Pennsylvania 19111
Philadelphia, Pennsylvania 19111
Guthrie Sayre
Sayre, Pennsylvania 18840
Sayre, Pennsylvania 18840
Bon Secours St. Francis Cancer Center
Charleston, South Carolina 29414
Charleston, South Carolina 29414
Monument Health Cancer Care Institute
Rapid City, South Dakota 57701
Rapid City, South Dakota 57701
Avera Cancer Institute
Sioux Falls, South Dakota 57105
Sioux Falls, South Dakota 57105
West Cancer Center
Germantown, Tennessee 38138
Germantown, Tennessee 38138
Tennessee Cancer Specialists
Knoxville, Tennessee 37919
Knoxville, Tennessee 37919
Baptist Cancer Center
Memphis, Tennessee 38120
Memphis, Tennessee 38120
Sarah Cannon Cancer Institute
Nashville, Tennessee 37203
Nashville, Tennessee 37203
Tennessee Oncology
Nashville, Tennessee 37203
Nashville, Tennessee 37203
DHR Health
Edinburg, Texas 78539
Edinburg, Texas 78539
Houston Methodist Hospital- Cancer Center
Houston, Texas 77030
Houston, Texas 77030
MD Anderson Cancer Center
Houston, Texas 77030
Houston, Texas 77030
Texas Oncology
Pearland, Texas 77584
Pearland, Texas 77584
Methodist Richardson Cancer Center
Richardson, Texas 75082
Richardson, Texas 75082
Utah Cancer Specialists (UCS)
Salt Lake City, Utah 84106
Salt Lake City, Utah 84106
Huntsman Cancer Institute & Hospital
Salt Lake City, Utah 84112
Salt Lake City, Utah 84112
University of Vermont Medical Center
Burlington, Vermont 05401
Burlington, Vermont 05401
Virginia Cancer Specialists
Fairfax, Virginia 22031
Fairfax, Virginia 22031
Hematology Oncology Associates of Fredericksburg
Fredericksburg, Virginia 22408
Fredericksburg, Virginia 22408
Virginia Oncology Associates
Hampton, Virginia 23606
Hampton, Virginia 23606
Riverside Health
Newport News, Virginia 23320
Newport News, Virginia 23320
Virginia Cancer Institute
Richmond, Virginia 23229
Richmond, Virginia 23229
Kadlec Regional Medical Center
Kennewick, Washington 99336
Kennewick, Washington 99336
Seattle Integrative Cancer Center
Renton, Washington 98057
Renton, Washington 98057
Virginia Mason Medical Center
Seattle, Washington 98101
Seattle, Washington 98101
Swedish Cancer Institute Treatment Center
Seattle, Washington 98104
Seattle, Washington 98104
Fred Hutch Cancer Center
Seattle, Washington 98109
Seattle, Washington 98109
Providence St. Mary Medical Center
Walla Walla, Washington 99362
Walla Walla, Washington 99362
ThedaCare Regional Cancer Center
Appleton, Wisconsin 54611
Appleton, Wisconsin 54611
Aurora Medical Center
Grafton, Wisconsin 53024
Grafton, Wisconsin 53024
Emplify Health by Gundersen
La Crosse, Wisconsin 05461
La Crosse, Wisconsin 05461
University of Wisconsin
Madison, Wisconsin 53792
Madison, Wisconsin 53792
Marshfield Medical Center
Marshfield, Wisconsin 54449
Marshfield, Wisconsin 54449
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
Milwaukee, Wisconsin 53226
UW Health Cancer Center at ProHealth Care
Waukesha, Wisconsin 53072
Waukesha, Wisconsin 53072
PanOncology Centre
San Juan, Puerto Rico 00909
San Juan, Puerto Rico 00909
More Details
- NCT ID
- NCT07573215
- Status
- Available
- Sponsor
- Revolution Medicines, Inc.
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.