Expanded Access Program for Ripretinib in Treating Advanced Gastrointestinal Stromal Tumor (GIST)

Sponsor: Deciphera Pharmaceuticals, LLC

Expanded Access
Approved for Marketing
Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04148092

Provider View

This program provides early access to the drug ripretinib for patients with advanced gastrointestinal stromal tumor (GIST) who have already tried at least two other approved treatments. The program is available until ripretinib becomes commercially available or the sponsor decides to stop it.

Patient Parameters

Program Overview

This is a special program that allows patients with advanced GIST, a type of cancer that affects the digestive system, to access the drug ripretinib before it is widely available. It is intended for patients whose cancer cannot be removed by surgery or has spread to other parts of the body, and who have already been treated with at least two other approved medications for GIST. The program will continue until ripretinib is available for purchase or the sponsor ends the program.

Description

The Expanded Access Program (EAP) for ripretinib is no longer accepting new patients in the United States.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of gastrointestinal stromal tumor (GIST).
  • Have previously been treated with at least two FDA-approved drugs for GIST, such as imatinib, sunitinib, and regorafenib.
  • Women who can become pregnant must have a negative pregnancy test before starting the program.
  • Must agree to use effective birth control if they can have children.
  • Must understand the study and agree to follow the program's requirements, including signing a consent form.
  • Must have good organ function and bone marrow health as determined by the doctor.
  • Any serious side effects from previous treatments must have improved to a mild level before starting ripretinib.

Exclusion Criteria

  • Can join another clinical study that offers ripretinib.
  • Have received any cancer treatment or experimental therapy within 7 days or 5 times the drug's half-life before starting ripretinib.
  • Have previously been treated with ripretinib.
  • Have active cancer that has spread to the brain or spinal cord.
  • Are receiving treatment for another cancer that could interfere with ripretinib's benefits.
  • Have had major surgery within 4 weeks before starting ripretinib, unless fully healed.
  • Have other significant health issues that could pose safety risks.
  • Have HIV or hepatitis C and are taking medications that conflict with the study.
  • Have active hepatitis B or C.
  • Are pregnant or breastfeeding.
  • Have an allergy to any part of the study drug.
  • Have a history of severe skin reactions to similar drugs.
  • Have digestive issues that prevent taking oral medication or require intravenous feeding.
  • Have any active bleeding, except minor bleeding like from hemorrhoids or gums.

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