Access to Velzatinib for Patients with Gastrointestinal Stromal Tumors with KIT Mutations

Sponsor: GlaxoSmithKline

Expanded Access
Sponsor score: 60

ClinicalTrials ID:NCT07825701

Provider View

This program offers access to the drug Velzatinib for patients with Gastrointestinal Stromal Tumors (GIST) who have specific KIT mutations and have already tried at least three other treatments.

Patient Parameters

Program Overview

This program provides compassionate use of Velzatinib for patients with Gastrointestinal Stromal Tumors (GIST) that have KIT mutations. It is intended for those who have already undergone at least three different treatments. The aim is to offer another treatment option for eligible patients.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with Gastrointestinal Stromal Tumor (GIST) and have a KIT mutation.
  • Have tried at least three previous treatments.
  • Have good organ function.
  • Able to provide written consent to participate.
  • Aged 18 years or older.
  • Agree to use effective birth control during treatment and for 30 days after.
    • Women must use effective contraception or abstain from sex if they can become pregnant.
    • Men must use condoms and ensure their partners use effective contraception if their partners can become pregnant.

Exclusion Criteria

  • Have an active, uncontrolled infection.
  • Allergic to Velzatinib or its ingredients.
  • Pregnant or breastfeeding women.
  • Have liver enzyme levels that are too high.
  • Have severe liver disease or cirrhosis.
  • Have Hepatitis B unless specific conditions are met, such as undetectable viral load and proper monitoring.
  • Have Hepatitis C unless treated successfully and have a negative viral load test after treatment.

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