OncoMatch/Clinical Trials/NCT07171203
Neoadjuvant Imatinib and Fampridine in KIT Mutant Gastrointestinal Stromal Tumor
Is NCT07171203 recruiting? Yes, currently enrolling (May 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 (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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Gastrointestinal Stromal Tumor
Biomarker criteria
Required: KIT exon 11 mutation
KIT exon 11 mutant gastrointestinal stromal tumor assessed for KIT variant mutations by next generation sequencing
Required: KIT mutation
Non-KIT mutant gastrointestinal stromal tumor
Excluded: KIT exon 9 mutation
KIT exon 9, 13, 14, 17, or 18 mutant gastrointestinal stromal tumor by next generation sequencing
Excluded: KIT exon 13 mutation
KIT exon 9, 13, 14, 17, or 18 mutant gastrointestinal stromal tumor by next generation sequencing
Excluded: KIT exon 14 mutation
KIT exon 9, 13, 14, 17, or 18 mutant gastrointestinal stromal tumor by next generation sequencing
Excluded: KIT exon 17 mutation
KIT exon 9, 13, 14, 17, or 18 mutant gastrointestinal stromal tumor by next generation sequencing
Excluded: KIT exon 18 mutation
KIT exon 9, 13, 14, 17, or 18 mutant gastrointestinal stromal tumor by next generation sequencing
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: imatinib monotherapy (imatinib)
Received imatinib monotherapy prior to the first dose of study treatment with imatinib plus fampridine and has demonstrated tumor shrinkage in computed tomography assessment images.
Cannot have received: fampridine (fampridine)
Received fampridine prior to the first dose of study treatment with imatinib plus fampridine.
Cannot have received: compounded fampridine or other forms of fampridine
Use of compounded fampridine or other forms of fampridine.
Cannot have received: anti-neoplastic therapy
Receiving other anti-neoplastic therapy (e.g., chemotherapy, targeted therapy, or radiotherapy) concurrently or within 4 weeks of starting study treatment with imatinib plus 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 upper limit of normal or calculated creatinine clearance ≥ 50ml/min based upon the Cockcroft-Gault Equation; Plasma creatinine phosphokinase < 1.5 x upper limit of normal
Liver function
Serum total bilirubin < 2.0 x upper limit of normal; AST and ALT ≤ 5 x upper limit of normal
Has adequate hematologic, hepatic, and renal function: Absolute Neutrophil Count ≥ 1.5 x 10^9/L; Hemoglobin ≥ 11 g/dL; Platelets ≥ 100 x 10^9/L; Serum total bilirubin < 2.0 x upper limit of normal; Aspartate aminotransferase and alanine aminotransferase ≤ 5 x upper limit of normal; Plasma creatinine phosphokinase < 1.5 x upper limit of normal; Serum creatinine ≤ 1.0 x upper limit of normal or calculated creatinine clearance ≥ 50ml/min based upon the Cockcroft-Gault Equation
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of California, San Diego · La Jolla, California
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