🏛️ Verified NIH Record • Updated 2025-10-29

SARC044: A Phase II Trial of Bezuclastinib in Combination With Sunitinib in Patients With GIST (NCT06208748)

🔵 Active, Not Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Sarcoma Alliance for Research through Collaboration

🩺 Plain-English Summary (8th-Grade Level)

This is an open label, single arm, phase 2 trial investigating bezuclastinib plus sunitinib in patients with GIST who have previously progressed on sunitinib.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (33 items) and avoid the listed exclusions (23 items).

Location: Sylvester Comprehensive Cancer Center, University of Miami — Miami, Florida

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • Prior exposure to bezuclastinib.
  • Prior anticancer drug less than 5 half-lives of the parent drug and/or its active metabolite(s) or 14 days (whichever is shorter) prior to the first dose of the study drug.
  • Received strong CYP3A4 inhibitor(s) or inducer(s) within 14 days or 5 drug half-lives before the first dose of the study drug, whichever is longer, or the need to continue treatment with strong CYP3A4 inhibitor(s) or inducer(s) during the study.
  • GIST without primary activating mutations in KIT exons 11 or 9. Other primary KIT activating mutations will be considered on a case-by-case basis. Patients with GIST with other mutations (e.g., PDGFRA, SDHx, BRAF, or NF1) or unknown genotype are excluded.
  • Known or suspected hypersensitivity to bezuclastinib or sunitinib and their components.
  • Unacceptable toxicity with prior sunitinib at 25 mg daily.
  • Clinically significant cardiac disease, defined by any of the following:
  • Clinically significant cardiac arrhythmias and/or the need for antiarrhythmic therapy (excluding beta blockers or digoxin). Subjects with controlled atrial fibrillation are not excluded.
  • Congenital long QT syndrome or use of concomitant medications known to prolong the QT interval as defined in Appendix D.
  • A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval \>470 milliseconds \[ms\] using Fridericia's QT correction formula).
  • Clinically significant history of cardiac disease or congestive heart failure \>New York Heart Association Class II. Subjects must not have unstable angina (anginal symptoms at rest) or new-onset angina within 3 months or myocardial infarction within 6 months prior to enrollment.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (4 Sites)

  • Sylvester Comprehensive Cancer Center, University of Miami — Miami, Florida
  • Dana Farber Cancer Institute — Boston, Massachusetts
  • Oregon Health & Science University — Portland, Oregon
  • Fox Chase Cancer Center — Philadelphia, Pennsylvania

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
🏛️ View Official NIH Record ↗