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RECRUITING
NCT07171203
PHASE1

Neoadjuvant Imatinib and Fampridine in KIT Mutant Gastrointestinal Stromal Tumor

Sponsor: University of California, San Diego

View on ClinicalTrials.gov

Summary

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 (neoadjuvant 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.

Official title: Phase I Study of Neoadjuvant Therapy Imatinib Mesylate and Fampridine in KIT Mutant Gastrointestinal Stromal Tumor (GIST)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

18

Start Date

2026-06

Completion Date

2031-07

Last Updated

2026-03-25

Healthy Volunteers

No

Interventions

DRUG

Imatinib

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.

DRUG

Fampridine

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.

Locations (1)

University of California, San Diego

La Jolla, California, United States