Phase II Study of Bezuclastinib and Sunitinib for Patients with GIST

Sponsor: Sarcoma Alliance for Research through Collaboration

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06208748

Provider View

This clinical trial is testing a new combination of drugs, bezuclastinib and sunitinib, for patients with gastrointestinal stromal tumors (GIST) who have not responded to sunitinib alone. The study aims to see if this combination can help control the cancer.

Patient Parameters

Program Overview

The study is exploring whether combining bezuclastinib with sunitinib can be effective for patients with GIST who have previously not responded to sunitinib. Participants will first stop taking sunitinib, then start bezuclastinib, and add sunitinib two weeks later. They will continue treatment until the cancer progresses, side effects become too severe, or they choose to stop. Regular scans will monitor the cancer's response, and blood samples will be collected to study tumor DNA. A subset of patients will also have additional scans and biopsies to gather more information.

Description

This trial is for patients with GIST who have not responded to sunitinib. Participants will first stop taking sunitinib, then start a new drug, bezuclastinib, and add sunitinib again after two weeks. They will continue this treatment until the cancer progresses, side effects become too severe, or they decide to stop. If the doctor believes the treatment is still helping, patients may continue even if the cancer progresses. Scans will be done every 8 weeks for the first 15 months, then every 3 months, to check the cancer's response. Blood samples will be collected at different times to study tumor DNA. A smaller group of 20 patients will have additional PET/CT scans and biopsies to gather more detailed information. Throughout the study, patients will complete a questionnaire about their quality of life.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of inoperable or metastatic GIST with specific genetic mutations (exon 11 or 9 KIT mutation).
  • Have previously tried and not responded to imatinib and sunitinib.
  • Have at least one measurable tumor on a scan.
  • Have recovered from any side effects of previous treatments.
  • Have adequate organ function based on blood tests.
  • Be able to swallow pills.
  • Agree to use effective birth control during the study and for 6 weeks after the last dose.
  • Have a life expectancy of more than 12 weeks.
  • If they have hepatitis B or C, it must be under control.
  • If they have had brain metastases, they must have been treated and stable.

Exclusion Criteria

  • Have previously taken bezuclastinib.
  • Have taken other cancer drugs recently.
  • Have certain genetic mutations not targeted by the study.
  • Have allergies to the study drugs.
  • Have severe heart problems or recent heart attacks.
  • Have had blood clots or strokes recently.
  • Have other cancers that could interfere with the study.
  • Have uncontrolled medical conditions or infections.
  • Be pregnant or breastfeeding.
  • Have untreated brain metastases.
  • Be unable to follow the study procedures.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.