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Neoadjuvant Imatinib and Fampridine in KIT Mutant Gastrointestinal Stromal Tumor

NCT07171203 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-03-25

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

Principal Investigators

  • Paul Fanta, MD · University of California, San Diego

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2030-07-31
Completion
2031-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT07171203 on ClinicalTrials.gov