Expanded Access Program for Daraxonrasib in Previously Treated Metastatic Pancreatic Cancer

Sponsor: Revolution Medicines, Inc.

Expanded Access
Sponsor score: 0

ClinicalTrials ID:NCT07573215

Provider View

This program provides access to the investigational drug daraxonrasib for adults with metastatic pancreatic cancer who have already received treatment but have no other suitable options and cannot join a current clinical trial.

Patient Parameters

Program Overview

The Expanded Access Program (EAP) offers the drug daraxonrasib to adults with metastatic pancreatic cancer who have already tried other treatments but have no other effective options and cannot participate in a clinical trial for daraxonrasib. This program aims to meet the needs of patients who are not benefiting from standard therapies and provides the drug free of charge during the treatment period.

Description

This program is designed to give patients with metastatic pancreatic cancer access to daraxonrasib, an investigational drug taken by mouth, before it becomes commercially available. Patients may qualify if they have tried other treatments but are not benefiting from them, cannot tolerate them, or cannot join a clinical trial for daraxonrasib. The drug is provided at no cost to patients during the program.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older and agree to participate.
  • Have a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have confirmed metastatic pancreatic cancer.
  • Show signs of cancer progression during or after the last treatment.
  • Have tried at least one previous treatment for metastatic cancer, including specific chemotherapy regimens.
  • Have not benefited from, cannot tolerate, or are not expected to benefit from standard treatments.
  • Have adequate blood, kidney, liver, and blood clotting function.
  • Cannot join another clinical trial for daraxonrasib.
  • Able to take oral medications.

Exclusion Criteria

  • Have known cancer spread to the brain or spinal cord.
  • Are receiving other cancer treatments at the same time.
  • Have serious heart disease.
  • Have major digestive issues that affect taking or absorbing the drug (except those who had a Whipple procedure).
  • Have an active, uncontrolled infection.
  • Have had major surgery within the last 28 days.
  • Other criteria may apply.

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