Neoplasms

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Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

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Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

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Sunitinib

Angiogenesis Inhibitors

Growth Inhibitors

Protein Kinase Inhibitors

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Bezuclastinib 600 mg (tablet) administered orally daily Sunitinib 37.5 mg administered orally daily

Patients will begin bezuclastinib and add sunitinib 2 weeks later. Each cycle is 28 days.

Bezuclastinib in combination with sunitinib (sutent)

Bezuclastinib in combination with sunitinib

SARC Office

Candace Haddox, MD

Andrew Wagner, MD, PhD

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

This is an open label, single arm, phase 2 trial investigating bezuclastinib plus sunitinib in patients with GIST who have previously progressed on sunitinib. After washout, patients will begin bezuclastinib and add sunitinib 2 weeks later. Patients will continue on treatment until progression, unacceptable toxicity, or withdrawal of consent. Patients may stay on treatment beyond progression if there is clinical benefit in the opinion of the investigator. Imaging response assessments will be performed every 8 weeks until the participant reaches 15 months on study. After 15 months, response assessments may be performed every 3 months. Circulating tumor DNA (ctDNA) will be collected at baseline, with sequential initiation of bezuclastinib and sunitinib, at the first response assessment, and at the time of progression. In a subset of 20 patients, PET/CT will be performed at baseline and with sequential initiation of bezuclastinib and sunitinib, and tumor biopsies will be performed on cycle 2 day 1 for correlative studies. EORTC QLQ-C30 will be administered during the study to assess patient-reported quality of life.

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

A Phase II Trial of Bezuclastinib in Combination With Sunitinib in Patients With GIST Who Progressed on Sunitinib Monotherapy

mPFS will be summarized with a Kaplan-Meier curve

Quality of life will be evaluated using the EORTC-QLQ-C30 with descriptive statistics reported at each timepoint. Changes in quality-of-life measures based on the EORTC-QLQ-C30 will be determined (difference at follow-up and baseline will be summarized). Changes in on-treatment scores compared to baseline will be analyzed to determine patients' perception of their functional status, symptoms, and overall health.

Cogent Biosciences, Inc.

Dana-Farber Cancer Institute

The Life Raft Group

Sarcoma Alliance for Research through Collaboration

Spots Global Cancer Trial Database for bezuclastinib in combination with sunitinib