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NCT07594548 · ClinicalTrials.gov registry record · Phase 1
Futibatinib With Paclitaxel and Ramucirumab for the Treatment of Locally Advanced or Unresectable Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma
A Phase 1 study, sponsored by Northwestern University.
- Not yet
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT07594548: Clinical Trial Phase 1 study, sponsored by Northwestern University.
NCT07594548 is a Phase 1 study that has not yet begun recruiting, run by Northwestern University. 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
NCT07594548, a Phase 1 study, has not yet begun recruiting, sponsored by Northwestern University.
- NOT YET RECRUITING
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
This phase I trial tests the safety, side effects and best dose of futibatinib with paclitaxel and ramucirumab for the treatment of patients with gastric, gastroesophageal junction or esophageal adenocarcinoma that has spread to nearby tissue or lymph nodes (locally advanced) or that cannot be removed by surgery (unresectable). Futibatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Giving futibatinib with paclitaxel and ramucirumab may be safe and tolerable in treating patients with locally advanced or unresectable gastric, gastroesophageal junction or esophageal adenocarcinoma.
Primary Outcome
Defined as the highest dose that causes dose-limiting toxicities (DLTs) in \< 2 of 6 subjects. Will be estimated using the Bayesian Optimal Interval algorithm based on observed DLTs. The frequency of DLTs at each dose level will be summarized using descriptive statistics, including proportions and confidence intervals.
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Magnetic Resonance Imaging
- DRUG Paclitaxel
- DRUG Futibatinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2027-09-09 |
| Est. Completion | 2031-09-09 |
| Phase | Phase 1 |
What is known before NCT07594548 opens enrollment
NCT07594548 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 5 interventions - of which Biospecimen Collection is the first listed.
NCT07594548 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07594548 about?
NCT07594548 is a clinical study titled "Futibatinib With Paclitaxel and Ramucirumab for the Treatment of Locally Advanced or Unresectable Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma". This phase I trial tests the safety, side effects and best dose of futibatinib with paclitaxel and ramucirumab for the treatment of patients with gastric, gastroesophageal junction or esophageal adenocarcinoma that has spread to nearby tissue or lymph nodes (locally advanced) or that cannot be remov...
What is the current status of trial NCT07594548?
This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2027-09-09. Estimated completion is 2031-09-09.
What interventions are being tested in trial NCT07594548?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Paclitaxel (DRUG), Futibatinib (DRUG).
Who is sponsoring clinical trial NCT07594548?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07594548'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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