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NCT04093362 · ClinicalTrials.gov registry record · Phase 3
Futibatinib Versus Gemcitabine-Cisplatin Chemotherapy as First-Line Treatment of Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements
A Phase 3 study, sponsored by Taiho Oncology.
- Terminated
- Registry status
- Phase 3
- Development phase
- 10
- Enrollment target
NCT04093362: Clinical Trial Phase 3 study, sponsored by Taiho Oncology.
NCT04093362 is a Phase 3 study that was terminated before completion, run by Taiho Oncology. The registered enrollment target is 10 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04093362, a Phase 3 study, was terminated before completion, sponsored by Taiho Oncology.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 10 participants
- Enrollment target
Study Summary
This is an open-label, multinational, parallel 2-arm, randomized Phase 3 study evaluating the efficacy and safety of futibatinib versus gemcitabine-cisplatin chemotherapy as first-line treatment of participants with advanced, metastatic, or recurrent unresectable intrahepatic cholangiocarcinoma (iCCA) harboring FGFR2 gene rearrangements
Primary Outcome
PFS was defined as the time from date of randomization to the date of documentation of disease progression by independent central review (ICR), or date of death, whichever occurs first. Response assessments were made based on Response Evaluation Criteria in Solid Tumors (RECIST) guidelines (version 1.1, 2009)
Interventions
- DRUG Cisplatin
- DRUG Gemcitabine
- DRUG Futibatinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2021-01-06 |
| Est. Completion | 2024-04-22 |
| Phase | Phase 3 |
Why NCT04093362 stopped before completion
NCT04093362 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 3 interventions - of which Cisplatin is the first listed.
NCT04093362 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04093362 about?
NCT04093362 is a clinical study titled "Futibatinib Versus Gemcitabine-Cisplatin Chemotherapy as First-Line Treatment of Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements". This is an open-label, multinational, parallel 2-arm, randomized Phase 3 study evaluating the efficacy and safety of futibatinib versus gemcitabine-cisplatin chemotherapy as first-line treatment of participants with advanced, metastatic, or recurrent unresectable intrahepatic cholangiocarcinoma (iCC...
What is the current status of trial NCT04093362?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 10 participants. The study started on 2021-01-06. Estimated completion is 2024-04-22.
What interventions are being tested in trial NCT04093362?
The interventions under investigation include: Cisplatin (DRUG), Gemcitabine (DRUG), Futibatinib (DRUG).
Who is sponsoring clinical trial NCT04093362?
This trial is sponsored by Taiho Oncology, which has 52 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04093362's enrollment target sits among peer trials
10 1989th of 2000 higher than 9 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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