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New treatment option for Gastrointestinal Stromal Tumors
Official title Preoperative Imatinib and Fampridine in KIT Mutant Gastrointestinal Stromal Tumor
ClinicalTrials.gov ID: NCT07171203
What this study is testing
What is Imatinib?
Imatinib is an investigational medicine, given as an once-daily treatment applied to the skin, being studied as a potential treatment for gastrointestinal stromal tumors.
Also referred to as Imatinib mesylate, Gleevec.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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)?
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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
See the full eligibility 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...
- 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
- 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...
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- La Jolla, California, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include La Jolla, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.