Preoperative Imatinib and Fampridine in KIT Mutant Gastrointestinal Stromal Tumor

Part of paid clinical trials in La Jolla, California.

Sponsor
University of California, San Diego
Study ID
NCT07171203
Phase
PHASE1
Status
Recruiting
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Conditions

  • Gastrointestinal Stromal Tumors

Eligibility Criteria

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

Interventions

  • Imatinib — DRUG
    Tyrosine kinase inhibitor. Imatinib will be dosed at 400 mg once a day. Dose can be reduced by 100 mg per dose reduction step if clinically indicated.
  • Fampridine — DRUG
    Voltage-gated potassium channel (VGKC) blocker. Fampridine will be dosed in a 3+3 design at 10 mg given either every 2 days, or every day, or twice a day.

Study Details

The goal of this clinical trial is to learn what dose of the drug fampridine can be given safely together with imatinib (Gleevec) in patients with gastrointestinal stromal tumor (GIST) with a DNA mutation in exon 11 of the KIT gene. The main questions this study aims to answer are: * What is the maximum dose of fampridine that can be given safely together with imatinib (Gleevec)? * Is the combination of the two drugs efficacious against the tumor? Participants will: * Take the drugs before tumor surgery (preoperative treatment) for at least 2 months with the option to continue for a longer period of time if treatment seems safe and effective. * Visit the clinic at the scheduled appointments for checkups and tests.

Key Dates

Start date
May 13, 2026
Status verified
May 2026
Primary completion
Jul 31, 2030
Completion
Jul 31, 2031

Study Design

Enrollment
18 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Imatinib plus Fampridine
    Imatinib in combination with fampridine at one of three dose levels (10 mg every other day, or 10 mg every day, or 10 mg twice a day) after a 7-day run-in period with imatinib monotherapy.

Primary Outcome Measure

Recommended phase 2 dose [ Time Frame: 28 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San DiegoLa JollaCalifornia92093
Paul Fanta, MD
[email protected]
858-822-5354
Gastrointestinal Research Team
[email protected]
858-822-5354
Paul Fanta, MD (PRINCIPAL_INVESTIGATOR)
Jason Sicklick, MD (SUB_INVESTIGATOR)

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