Clinical Trial 24368

• Overview

  Study Title:

  Expanded Access Program to Treat Patients with Previously Treated Metastatic Pancreatic Adenocarcinoma with Daraxonrasib

  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.

  Objective:

  Provide Multi Patient - Expanded Access Use of Daraxonrasib

• Treatments

  Medications:

  Daratumumab ()

• Inclusion Criteria

  Key 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

  Key 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.

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