PDAC, PDAC - Pancreatic Ductal Adenocarcinoma, Metastatic Pancreas Adenocarcinoma, Pancreatic Cancer, Pancreatic Cancer Metastatic, Pancreatic Adenocarcinoma Metastatic, Pancreatic Adenocarcinoma, Pancreatic Adenosquamous Carcinoma
Conditions
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
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.
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.
Interventions
DRUGdaraxonrasib
Oral tablets administered once daily
Sponsors
Revolution Medicines, Inc.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Contacts
CONTACTRevolution Medicines Study Director
Outcome results
None listed