Phase 2 Study of Pemigatinib for Advanced SDH-deficient Gastrointestinal Stromal Tumors (GIST)

Sponsor: Dana-Farber Cancer Institute

Sponsor score: 40

ClinicalTrials ID:NCT07434843

Provider View

This clinical trial is testing the effectiveness and safety of the drug pemigatinib for treating advanced gastrointestinal stromal tumors (GIST) that lack a specific enzyme called SDH. The study will also look at how well patients tolerate the drug.

Patient Parameters

Program Overview

The study aims to find out how well pemigatinib works in treating advanced gastrointestinal stromal tumors (GIST) that are missing an enzyme called SDH. Researchers will also monitor any side effects and how well patients can handle the treatment. Pemigatinib is not yet approved for this specific type of cancer but is used for other conditions. Participants will take the drug in cycles and undergo various tests and scans to track their progress.

Description

This study involves taking pemigatinib, a drug that is being tested for its ability to treat advanced gastrointestinal stromal tumors (GIST) that lack the SDH enzyme. The study is open-label, meaning both the researchers and participants know what treatment is being given. Participants will take pemigatinib in 21-day cycles until the cancer progresses or side effects become too severe. The study includes regular visits to the clinic for exams, blood tests, scans, and other procedures to monitor health and treatment effects. About 24 people are expected to participate. The drug is provided by Incyte, a biopharmaceutical company.

Eligibility Criteria

Inclusion Criteria

  • Must have advanced gastrointestinal stromal tumors (GIST) that lack the SDH enzyme and cannot be treated with surgery.
  • Must have at least one tumor that can be measured by scans or exams.
  • Cancer must be worsening as shown by recent scans.
  • Must be 18 years or older.
  • Must be in good general health with a performance status of 0 to 2.
  • Must have adequate blood counts and organ function.
  • Must not have other active cancers unless they have been cancer-free for over 5 years.
  • Must have completed any previous cancer treatments at least 2 weeks before starting the study.
  • Must be able to swallow pills and willing to follow study procedures.
  • Women of childbearing potential must have a negative pregnancy test and agree to use contraception.
  • Must understand and agree to sign a consent form.

Exclusion Criteria

  • Cannot be taking other experimental drugs.
  • Cannot have allergies to similar drugs as pemigatinib.
  • Cannot take certain medications that interact with pemigatinib.
  • Cannot have uncontrolled illnesses or psychiatric conditions that affect study participation.
  • Cannot have been treated with FGFR inhibitors before.
  • Cannot have certain eye conditions or abnormal calcium/phosphate levels.
  • Cannot have a history of severe vitamin D deficiency requiring high doses.
  • Cannot have a history of certain types of tissue calcifications.

Locations

FACILITYZIPCITYSTATE
Dana Farber Cancer Institute02215BostonMassachusetts

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