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Tyrosine Kinase Inhibitor

bezuclastinib in combination with sunitinib for Gastrointestinal Stromal Tumors

Phase 2

Waitlist Available

Led By Candace Haddox, MD

Research Sponsored by Sarcoma Alliance for Research through Collaboration

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured

Prior progression on or intolerance to imatinib

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the time of first dose to the occurrence of disease progression (as accessed by mrecist v1.1) or death due to any cause prior to documented disease progression, up to 2 years..

Awards & highlights

Study Summary

This trial is studying the combination of bezuclastinib and sunitinib in patients with GIST who have not responded well to sunitinib treatment.

Who is the study for?

This trial is for patients with Gastrointestinal Stromal Tumors (GIST) who have already tried sunitinib but their disease has progressed. Specific eligibility details are not provided, so interested individuals should inquire further to determine if they meet the inclusion and exclusion criteria.Check my eligibility

What is being tested?

The study is testing a combination of two drugs: Bezuclastinib and Sunitinib, in people with GIST. It's an open-label, single-arm phase II trial, meaning all participants will receive the same treatment without a comparison group or placebo.See study design

What are the potential side effects?

Potential side effects for this drug combination aren't specified here. However, common side effects from cancer treatments like these can include fatigue, nausea, diarrhea, skin issues and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I had hepatitis C but have been treated and cured.

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My condition worsened or I couldn't tolerate imatinib.

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My cancer progressed despite taking sunitinib regularly.

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My scans show at least one area of cancer that can be measured.

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My hepatitis B is under control with treatment.

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My side effects from previous treatments are mild or gone.

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I am at least 18 years old.

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I can take care of myself and am up and about more than half of my waking hours.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the time of first dose to the occurrence of disease progression (as accessed by mrecist v1.1) or death due to any cause prior to documented disease progression, up to 2 years..

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the time of first dose to the occurrence of disease progression (as accessed by mrecist v1.1) or death due to any cause prior to documented disease progression, up to 2 years..

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the time of first dose to the occurrence of disease progression (as accessed by mrecist v1.1) or death due to any cause prior to documented disease progression, up to 2 years.. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

To estimate the median progression free survival (mPFS)

Secondary outcome measures

To describe patient-reported quality of life outcome measures.

To describe the adverse event profile of bezuclastinib in combination with sunitinib.

To determine KIT mutations in tumor tissue and circulating tumor DNA (ctDNA) associated with primary and acquired resistance to combination bezuclastinib and sunitinib.

+3 more

Side effects data

From 2017 Phase 2 & 3 trial • 78 Patients • NCT01164202

31%

Platelets

28%

Neutrophiles

26%

Bilirubine

23%

Asthenia

21%

ASAT

21%

ALAT

15%

Leucocytose

13%

Hand-foot syndrome

13%

Liver failure

10%

Abdominal pain

Anorexia

Fever

Increase GGT

Arterial hypertension

Encephalopathy

Diarrhea

Ascite

Phosphatases alcalines

Liver pain

Encephalopathia

Hemoglobine

Lumbar pain

Hemoglobin

Prothrombin time

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Sunitinib

Trial Design

1Treatment groups

Experimental Treatment

Group I: bezuclastinib in combination with sunitinibExperimental Treatment1 Intervention

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.

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Sarcoma Alliance for Research through CollaborationLead Sponsor

25 Previous Clinical Trials

1,914 Total Patients Enrolled

3 Trials studying Gastrointestinal Stromal Tumors

371 Patients Enrolled for Gastrointestinal Stromal Tumors

Cogent Biosciences, Inc.Industry Sponsor

9 Previous Clinical Trials

858 Total Patients Enrolled

2 Trials studying Gastrointestinal Stromal Tumors

477 Patients Enrolled for Gastrointestinal Stromal Tumors

The Life Raft GroupUNKNOWN

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the number of medical facilities conducting this study in North America substantial?

"This research study is conducted at Sylvester Comprehensive Cancer Center, University of Miami (Miami, Florida), Dana Farber Cancer Institute (Boston, Massachusetts), Fox Chase Cancer Center (Philadelphia, Pennsylvania), and four additional locations."

Answered by AI

Are there any vacancies available for patients to participate in this trial?

"As per the information on clinicaltrials.gov, this particular clinical trial is not actively seeking participants at present. The study was initially posted on March 1st, 2024 and last updated on January 5th, 2024. However, it's worth noting that there are currently 48 other trials available for enrollment to interested individuals."

Answered by AI

Has the combination of bezuclastinib and sunitinib received official endorsement from the FDA?

"Based on our assessment at Power, the safety of bezuclastinib in combination with sunitinib is rated as 2. This rating aligns with it being a Phase 2 trial, indicating that there is some existing data suggesting safety but no evidence supporting efficacy yet."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "SARC044: A Phase II Trial of Bezuclastinib in Combination With Sunitinib in Patients With GIST". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06208748.

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