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NCT04088188 · ClinicalTrials.gov registry record · Phase 1
Gemcitabine and Cisplatin With Ivosidenib or Pemigatinib for the Treatment of Unresectable or Metastatic Cholangiocarcinoma
A Phase 1 study, sponsored by Academic and Community Cancer Research United.
- Terminated
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT04088188: Clinical Trial Phase 1 study, sponsored by Academic and Community Cancer Research United.
NCT04088188 is a Phase 1 study that was terminated before completion, run by Academic and Community Cancer Research United. The registered enrollment target is 8 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04088188, a Phase 1 study, was terminated before completion, sponsored by Academic and Community Cancer Research United.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
Study Summary
This phase I trial studies the side effects and best dose of gemcitabine and cisplatin when given together with ivosidenib or pemigatinib in treating patients with cholangiocarcinoma that cannot be removed with surgery (unresectable) or has spread to other places in the body (metastatic). Chemotherapy drugs, such as gemcitabine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Ivosidenib and pemigatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gemcitabine and cisplatin with ivosidenib or pemigatinib may work better in treating patients with cholangiocarcinoma compared to gemcitabine and cisplatin alone.
Primary Outcome
A significant toxicity is defined as a Dose Limiting Toxicity that is possibly, probably, or definitely related to treatment. DLTs will be evaluated starting in the first cycle of combination treatment and up to 3 weeks of combination treatment. Toxicities will be assessed using the CTEP Active Version of the CTCAE. All patients meeting the eligibility criteria who have signed a consent form and have begun combination treatment will be considered evaluable for significant toxicity. Patients, who
Interventions
- DRUG Cisplatin
- DRUG Gemcitabine
- DRUG Ivosidenib
- DRUG Pemigatinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2021-01-25 |
| Est. Completion | 2023-12-01 |
| Phase | Phase 1 |
Why NCT04088188 stopped before completion
NCT04088188 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 4 interventions - of which Cisplatin is the first listed.
NCT04088188 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04088188 about?
NCT04088188 is a clinical study titled "Gemcitabine and Cisplatin With Ivosidenib or Pemigatinib for the Treatment of Unresectable or Metastatic Cholangiocarcinoma". This phase I trial studies the side effects and best dose of gemcitabine and cisplatin when given together with ivosidenib or pemigatinib in treating patients with cholangiocarcinoma that cannot be removed with surgery (unresectable) or has spread to other places in the body (metastatic). Chemothera...
What is the current status of trial NCT04088188?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2021-01-25. Estimated completion is 2023-12-01.
What interventions are being tested in trial NCT04088188?
The interventions under investigation include: Cisplatin (DRUG), Gemcitabine (DRUG), Ivosidenib (DRUG), Pemigatinib (DRUG).
Who is sponsoring clinical trial NCT04088188?
This trial is sponsored by Academic and Community Cancer Research United, which has 42 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04088188's enrollment target sits among peer trials
8 1959th of 2000 higher than 29 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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