This study is not accepting new patients

Expanded Access to Bezuclastinib to be Coadministered With Sunitinib for Patients With Gastrointestinal Stromal Tumors

a study on Gastrointestinal Stromal Tumor Gastrointestinal Cancer Digestive System Tumor

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started

Description

Summary

The purpose of this expanded access program (EAP) is to provide investigational bezuclastinib so that it can be coadministered with sunitinib to patients with a diagnosis of gastrointestinal stromal tumors (GIST) with no comparable or satisfactory alternative therapy options. The combination of bezuclastinib and sunitinib provides broad inhibition of all primary and secondary KIT mutations that commonly occur in GIST.

Official Title

Expanded Access to Bezuclastinib to be Coadministered With Sunitinib for Patients With Locally Advanced, Unresectable, or Metastatic Gastrointestinal Stromal Tumors

Keywords

Gastrointestinal Neoplasms, Gastrointestinal Stromal Tumors, Solid Tumors, Sunitinib, Bezuclastinib, Gastrointestinal Stromal Tumors, Gastrointestinal Neoplasms, Digestive System Neoplasms

Eligibility

You can join if…

Open to people ages 18 years and up

  • Able to provide written informed consent and commit to recommended EAP assessments.
  • ≥18 years of age.
  • Able to swallow tablets.
  • Histologically confirmed locally advanced, metastatic, and/or unresectable GIST.
  • Intolerant to imatinib or received prior imatinib therapy for treatment of advanced, metastatic, and/or unresectable GIST that resulted in disease progression.
  • Meet clinically acceptable local laboratory results.

You CAN'T join if...

  • Patients who are eligible for and capable of participating in and/or enrolled in an on-going bezuclastinib clinical trial.
  • Prior or known intolerance to sunitinib.
  • Patients who have previously participated in a bezuclastinib clinical trial.
  • Patients with persistent > Grade 2 toxicities from prior therapy.
  • Known PDGFR driving mutations or known SDH deficiency.
  • Pregnant or currently breastfeeding.

Other protocol-defined criteria apply.

Locations

  • UCLA Department of Medicine- Hematology/Oncology not accepting new patients
    Los Angeles California 90095 United States
  • MD Anderson Cancer Center not accepting new patients
    Houston Texas 77030 United States
  • Orlando Health not accepting new patients
    Orlando Florida 32806 United States
  • Dana Farber Cancer Institute (DFCI) not accepting new patients
    Boston Massachusetts 02215 United States

Details

Status
not accepting new patients
Start Date
Sponsor
Cogent Biosciences, Inc.
ID
NCT06948955
Study Type
Expanded Access
Last Updated