OncoMatch/Clinical Trials/NCT07171203
Preoperative Imatinib and Fampridine in KIT Mutant Gastrointestinal Stromal Tumor
Is NCT07171203 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1 trial studies multiple treatments including Imatinib and Fampridine for gastrointestinal stromal tumors.
Treatment: Imatinib · Fampridine — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Other
Cancer type
Gastrointestinal Stromal Tumor
Biomarker criteria
Required: KIT exon 11 mutation
Excluded: KIT exon 13 mutation
Excluded: KIT exon 14 mutation
Excluded: KIT exon 17 mutation
Excluded: KIT exon 18 mutation
Excluded: KIT exon 9 mutation
Excluded: KIT wild-type
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: imatinib monotherapy (imatinib)
Exception: if received prior to first dose of study treatment with imatinib plus fampridine and has demonstrated tumor shrinkage in computed tomography assessment images
Cannot have received: fampridine (fampridine)
Cannot have received: compounded fampridine or other forms of fampridine
Lab requirements
Blood counts
absolute neutrophil count ≥ 1.5 x 10^9/l; hemoglobin ≥ 11 g/dl; platelets ≥ 100 x 10^9/l
Kidney function
serum creatinine ≤ 1.0 x uln or calculated creatinine clearance ≥ 50ml/min
Liver function
serum total bilirubin < 2.0 x uln; ast and alt ≤ 5 x uln; plasma creatinine phosphokinase < 1.5 x uln; serum creatinine ≤ 1.0 x uln or calculated creatinine clearance ≥ 50ml/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of California, San Diego · La Jolla, California
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07171203 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require KIT?
Yes, KIT exon 11 mutation is a required biomarker for enrollment.
Are patients with KIT alterations eligible?
No. KIT exon 13 mutation is an exclusion criterion.
Are patients with KIT alterations eligible?
No. KIT exon 14 mutation is an exclusion criterion.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages