drugset / Trial / NCT07171203

Preoperative Imatinib and Fampridine in KIT Mutant Gastrointestinal Stromal Tumor

NCT07171203

Phase 1 Recruiting 18 enrolled University of California, San Diego
NaSingle-groupOpen-labelTreatment

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 (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.

Timeline

Start
2026-05-13
Primary completion
2030-07
Completion
2031-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Dalfampridine Small molecule 10 mg
Subject Imatinib Small molecule 400 mg