Expanded Access Program To Treat Patients With Previously Treated Metastatic Pancreatic Adenocarcinoma With Draxonrasib.
The purpose of this EAP is to provide Daraxonrasib to qualifying patients with cancers with K-RAS mutations.
- RWJBarnabas Health
- Clara Maass Medical Center
- Community Medical Center
- Cooperman Barnabas, Livingston
- Jersey City Medical Center, Jersey City
- Monmouth Medical Center
- Monmouth Medical Center Southern Campus
- Newark Beth Israel Medical Center
- Robert Wood Johnson University Hospital, Hamilton
- Robert Wood Johnson University Hospital, Somerset
- Rutgers University
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.
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
For further information about clinical trials, please contact us at 732-235-7356.