MedTrace Logo

ctDNA-Guided Sunitinib And Regorafenib Therapy for GIST

NCT05366816 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-09-09

No results posted yet for this study

Summary

The purpose of this research is to test if mutations (changes in DNA) in exons (segment of DNA or RNA containing information that has the instructions for making proteins) in the KIT gene can be used to predict the body's response to standard of care treatment.

Conditions

Interventions

DRUG

Sunitinib

37.5 mg of Sunitinib orally (PO), once daily on a 28-day treatment cycle.

DRUG

Regorafenib

120.0 mg of Regorafenib, once daily by mouth 3 weeks on 1 week off on a 4-week treatment cycle.

Sponsors & Collaborators

  • University of Miami

    lead OTHER

Principal Investigators

  • Jonathan Trent, MD, PhD · University of Miami

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-17
Primary Completion
2026-12-31
Completion
2028-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05366816 on ClinicalTrials.gov