Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT07171203

Neoadjuvant Imatinib and Fampridine in KIT Mutant Gastrointestinal Stromal Tumor

Led by University of California, San Diego · Updated on 2026-03-25

18

Participants Needed

1

Research Sites

265 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Neoadjuvant Imatinib and Fampridine in KIT Mutant Gastrointestinal Stromal Tumor

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Provide written informed consent before any screening procedures
  • Be 18 years or older
  • Have a confirmed KIT exon 11 mutant gastrointestinal stromal tumor by next generation sequencing
  • Have treatment-naive gastrointestinal stromal tumor
  • Have a primary localized or locally advanced gastrointestinal stromal tumor suitable for neoadjuvant therapy before surgery
  • Have measurable or evaluable disease per Response Evaluation Criteria in Solid Tumors v1.1
  • Have an Eastern Cooperative Oncology Group Performance Status of 0 or 1
  • Have adequate blood counts and organ function as defined by study criteria
  • Have a life expectancy of at least 5 years
  • Agree to use effective contraception starting with the first dose and for 120 days after the last dose if able to cause pregnancy
Not Eligible

You will not qualify if you...

  • Unable or unwilling to follow the study protocol
  • Have KIT exon 9, 13, 14, 17, or 18 mutant gastrointestinal stromal tumor
  • Have non-KIT mutant gastrointestinal stromal tumor
  • Newly diagnosed with metastatic gastrointestinal stromal tumor
  • Have residual tumor after surgical debulking
  • Had major surgery within 4 weeks before starting study medication
  • Are of childbearing potential
  • Are pregnant or nursing
  • Previously received imatinib monotherapy with tumor shrinkage before study treatment
  • Previously received fampridine or compounded forms of fampridine
  • Have known brain metastases or progressive neurologic dysfunction
  • Have severe or uncontrolled systemic diseases like unstable respiratory or heart disease
  • Have cardiac impairment including serious heart failure or recent heart attack
  • Have unresolved significant toxicity from prior anti-cancer therapy
  • Have allergy or sensitivity to fampridine, aminopyridine products, or imatinib
  • Have chronic liver disease or certain liver conditions, with exceptions for specific age and disease status
  • Have history or evidence of hepatitis B or C
  • Have uncontrolled infection, diabetes, or cardiac disease making study unsafe
  • Have serious medical or psychiatric illness that could affect safety or study participation
  • Have history of seizures
  • Cannot swallow oral medications or have malabsorption
  • Participated in another experimental drug study within 4 weeks before study treatment
  • Receiving other anti-cancer treatments within 4 weeks before study treatment
  • Taking medications that inhibit renal Organic Cation Transporter 2 or strong CYP3A4/5, CYP2E1, CYP2B6, or CYP2C9/19 inhibitors or inducers with narrow therapeutic index

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of California, San Diego

La Jolla, California, United States, 92093

Actively Recruiting

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Research Team

P

Paul Fanta, MD

CONTACT

J

Jason Sicklick, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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