ctDNA-Guided Sunitinib And Regorafenib Therapy for GIST

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT05366816
Phase
PHASE2
Status
Recruiting
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Conditions

  • Gastrointestinal Stromal Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sunitinib — DRUG
    37.5 mg of Sunitinib orally (PO), once daily on a 28-day treatment cycle.
  • Regorafenib — DRUG
    120.0 mg of Regorafenib, once daily by mouth 3 weeks on 1 week off on a 4-week treatment cycle.

Study Details

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.

Key Dates

Start date
Oct 17, 2023
Status verified
Sep 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2028

Study Design

Enrollment
48 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group A: KIT Exon 13 receiving Sunitinib
    Participants with KIT mutation on exon 13 will receive Sunitinib. Participants showing disease progression after first-assigned Sunitinib therapy have the option to receive Regorafenib therapy. Total allotted time for treatment is up to 12 months.
  • Experimental: Group B: KIT Exon 17 receiving Regorafenib
    Participants with KIT mutation on exon 17 will receive Regorafenib. Participants showing disease progression after first-assigned Regorafenib therapy have the option to receive Sunitinib therapy. Total allotted time for treatment is up to 12 months.

Primary Outcome Measure

Number of Participants Achieving Overall Response [ Time Frame: Up to 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33136
Leonela Wright
[email protected]
305-243-0864
Jonathan Trent, MD, PhD
[email protected]
305-243-2581
Jonathan Trent, MD, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Miami· Miami, FL

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