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NCT07171203 · ClinicalTrials.gov registry record · Phase 1
Preoperative Imatinib and Fampridine in KIT Mutant Gastrointestinal Stromal Tumor
A Phase 1 study, sponsored by University of California, San Diego.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT07171203: Recruiting Phase 1 study, sponsored by University of California, San Diego.
NCT07171203 is a Phase 1 study that is actively recruiting participants, run by University of California, San Diego. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07171203, a Phase 1 study, is actively recruiting participants, sponsored by University of California, San Diego.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study 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.
Primary Outcome
Recommended phase 2 dose (RP2D) of imatinib plus fampridine determined by the dose-limiting toxicities and maximum tolerated dose via assessment of adverse events as defined by CTCAE version 5.0 during the first cycle (28 days) of therapy.
Interventions
- DRUG Imatinib
- DRUG Fampridine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2026-05-13 |
| Est. Completion | 2031-07 |
| Phase | Phase 1 |
What NCT07171203 shows while recruiting
NCT07171203 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 2 interventions - of which Imatinib is the first listed.
NCT07171203 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07171203 about?
NCT07171203 is a clinical study titled "Preoperative Imatinib and Fampridine in KIT Mutant Gastrointestinal Stromal Tumor". 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 m...
What is the current status of trial NCT07171203?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2026-05-13. Estimated completion is 2031-07.
What interventions are being tested in trial NCT07171203?
The interventions under investigation include: Imatinib (DRUG), Fampridine (DRUG).
Who is sponsoring clinical trial NCT07171203?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07171203's enrollment target sits among peer trials
18 1720th of 2000 higher than 216 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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