Brief Summary
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.
Brief Title
Expanded Access Program for Daraxonrasib (RMC-6236) in Previously Treated Metastatic Pancreatic Adenocarcinoma
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.
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.
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Phone
1-844-2-REVMED
Central Contact Email
medinfo@revmed.com
Conditions
PDAC
PDAC - PANCREATIC DUCTAL ADENOCARCINOMA
METASTATIC PANCREAS ADENOCARCINOMA
PANCREATIC CANCER
PANCREATIC CANCER METASTATIC
PANCREATIC ADENOCARCINOMA METASTATIC
PANCREATIC ADENOCARCINOMA
PANCREATIC ADENOSQUAMOUS CARCINOMA
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 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.
* 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.
Inclusion 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 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
inclusion and
* 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
inclusion and
Gender
All
Gender Based
false
Keywords
Expanded Access Program (EAP)
EAP
Daraxonrasib
RMC-6236
RMC-0706236
Metastatic pancreatic adenocarcinoma
Pancreatic ductal adenocarcinoma (PDAC)
RAS(ON) inhibitor
Unmet medical need
Pancreatic cancer
RAS
KRAS
Pancreatic Cancer Metastatic
Pancreatic Adenocarcinoma Metastatic
Pancreatic Adenosquamous Carcinoma
Pancreatic Adenocarcinoma
Compassionate Use
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT07573215
Org Class
Industry
Org Full Name
Revolution Medicines, Inc.
Org Study Id
RMC-6236-401
Overall Status
Available
Official Title
Expanded Access Program to Treat Patients With Previously Treated Metastatic Pancreatic Adenocarcinoma With Daraxonrasib
See Also Links
Url
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Fernand Bteich
Investigator Department
Medicine
Investigator Division
Oncology
Investigator Sponsor Organization
External
Study Department
Oncology (Medical/Hematologic)
Study Division
Medical and Hematologic Oncology
Categories Mesh Debug
Gastrointestinal (GI) Cancers --- DIGESTIVE SYSTEM NEOPLASMS
Cancer --- NEOPLASMS BY SITE
Cancer --- NEOPLASMS
Endocrine System Cancers --- ENDOCRINE GLAND NEOPLASMS
Digestive System --- DIGESTIVE SYSTEM DISEASES
Liver --- DIGESTIVE SYSTEM DISEASES
Diabetes --- ENDOCRINE SYSTEM DISEASES
Diabetes & Endocrine System --- ENDOCRINE SYSTEM DISEASES
MeSH Terms
PANCREATIC NEOPLASMS
DIGESTIVE SYSTEM NEOPLASMS
NEOPLASMS BY SITE
NEOPLASMS
ENDOCRINE GLAND NEOPLASMS
DIGESTIVE SYSTEM DISEASES
PANCREATIC DISEASES
ENDOCRINE SYSTEM DISEASES