NCT07171203 Preoperative Imatinib and Fampridine in KIT Mutant Gastrointestinal Stromal Tumor
| NCT ID | NCT07171203 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | University of California, San Diego |
| Condition | Gastrointestinal Stromal Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 18 participants |
| Start Date | 2026-05-13 |
| Primary Completion | 2030-07 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 18 participants in total. It began in 2026-05-13 with a primary completion date of 2030-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Provision of written informed consent prior to any screening procedures * Age ≥ 18 years * Having been pathologically confirmed to have a KIT exon 11 mutant gastrointestinal stromal tumor assessed for KIT variant mutations by next generation sequencing * Treatment naïve gastrointestinal stromal tumor * Described as a primary localized, locally advanced, or metastatic gastrointestinal stromal tumor in any location that would benefit from preoperative therapy before tumor surgical resection * Has measurable or evaluable disease per Response Evaluation Criteria in Solid Tumors v1.1. * Has Eastern Cooperative Oncology Group Performance Status of 0-1 * 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 * Life expectancy of ≥ 5 years * Participants able to cause pregnancy agree to use an adequate method of contraception starting with the first dose of study therapy and for 120 days after the last dose Exclusion Criteria: * Unwilling or unable to comply with the protocol * KIT exon 9, 13, 14, 17, or 18 mutant gastrointestinal stromal tumor by next generation sequencing. * Non-KIT mutant gastrointestinal stromal tumor * Have residual tumor following surgical debulking * Have had major surgery within 4 weeks of initiation of study medication. * Of childbearing potential * Pregnant or nursing. * 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. * Received fampridine prior to the first dose of study treatment with imatinib plus fampridine. * Use of compounded fampridine or other forms of fampridine. * Known brain metastases and any other progressive neurologic dysfunction should be excluded from this clinical trial because of their poor prognosis and because their progressive neurologic dysfunction would confound the evaluation of neurologic and other adverse events. * Evidence of severe or uncontrolled systemic diseases (e.g., unstable, or uncompensated respiratory, cardiac \[including life threatening arrhythmias\] disease). * Presence of cardiac impairment defined as: * Prior history of cardiovascular disease including heart failure that meets New York Heart Association (NYHA) class III and IV definitions; OR * History of myocardial infarction/active ischemic heart disease within one year of study entry; OR * Uncontrolled dysrhythmias; OR * Poorly controlled angina. * Unresolved toxicity Common Terminology Criteria Adverse Events (CTCAE) Grade ≥ 2 from previous anti-cancer therapy. * Allergy or sensitivity to fampridine or known allergies to aminopyridine products, which in the opinion of the investigator(s) suggests an increased potential for an adverse hypersensitivity to fampridine. * Allergy to imatinib. * Any chronic liver disease including, but not limited to cirrhosis, non-alcoholic steatohepatitis, alcohol-related liver disease, hemochromatosis, Wilson's disease, alpha-1 antitrypsin deficiency, hepatic, or biliary autoimmune disorders (i.e., primary biliary cholangitis, autoimmune hepatitis). Exception: Patients aged ≤ 65 years with non-alcoholic fatty liver disease detected by imaging are acceptable if adequate hepatic function as defined in the inclusion criteria is confirmed. Note: Patients aged \> 65 years with non-alcoholic fatty liver disease are excluded from the study. * Any evidence or history of hepatitis B and/or hepatitis C. * Medical condition such as uncontrolled infection, uncontrolled diabetes mellitus or cardiac disease that, in the opinion of the investigator(s), would make this study unreasonably hazardous for the patient. * Any other disease or clinically significant abnormality in laboratory parameters, including serious medical or psychiatric illness/condition, which in the judgment of the investigator(s) likely might compromise the safety of the participant or the integrity of the study, interfere with the participant participation in the trial, or compromise the trial objectives. * History of seizures. * Cannot swallow oral formulations of the medications or lack physical integrity of the upper gastrointestinal tract, or has known malabsorption syndromes. Note: imatinib tablets can be dissolved in water or apple juice if participants have difficulty swallowing. * Have taken part in an experimental drug study within 4 weeks of initiating study treatment with imatinib plus fampridine * 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 * Receiving medications that inhibit the renal Organic Cation Transporter 2 (OCT2), such as cimetidine and quinidine, because of possible drug-drug interactions. * Receiving medications known to be strong inhibitors or inducers of CYP3A4/5. * Receiving medications known to be strong inhibitors or inducers of cytochrome CYP2E1 or medications metabolized by cytochrome CYP2B6 or CYP2C9/19 that have narrow therapeutic index and that cannot be discontinued before starting study treatment.
Contact & Investigator
Paul Fanta, MD
PRINCIPAL INVESTIGATOR
University of California, San Diego
Frequently Asked Questions
Who can join the NCT07171203 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Gastrointestinal Stromal Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07171203 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07171203 currently recruiting?
Yes, NCT07171203 is actively recruiting participants. Contact the research team at cancerCTO@health.ucsd.edu for enrollment information.
Where is the NCT07171203 trial being conducted?
This trial is being conducted at La Jolla, United States.
Who is sponsoring the NCT07171203 clinical trial?
NCT07171203 is sponsored by University of California, San Diego. The principal investigator is Paul Fanta, MD at University of California, San Diego. The trial plans to enroll 18 participants.