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NCT03656536 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Chemotherapy in Unresectable or Metastatic Cholangiocarcinoma
A Phase 3 study, sponsored by Incyte Corporation.
- Terminated
- Registry status
- Phase 3
- Development phase
- 167
- Enrollment target
NCT03656536: Clinical Trial Phase 3 study, sponsored by Incyte Corporation.
NCT03656536 is a Phase 3 study that was terminated before completion, run by Incyte Corporation. The registered enrollment target is 167 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03656536, a Phase 3 study, was terminated before completion, sponsored by Incyte Corporation.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 167 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy and safety of pemigatinib versus gemcitabine plus cisplatin chemotherapy in first-line treatment of participants with unresectable or metastatic cholangiocarcinoma with FGFR2 rearrangement.
Primary Outcome
PFS was defined as the time from the date of randomization until the date of disease progression (according to Response Evaluation Criteria in Solid Tumors version 1.1 \[RECIST v1.1\] and assessed by an Independent Central Review \[ICR\]) or death, whichever occurs first.
Interventions
- DRUG Cisplatin
- DRUG Gemcitabine
- DRUG Pemigatinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 167 participants |
| Start Date | 2019-06-03 |
| Est. Completion | 2025-07-07 |
| Phase | Phase 3 |
Why NCT03656536 stopped before completion
NCT03656536 is an interventional study that assigns participants to a tested intervention. The registered 167 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 3 interventions - of which Cisplatin is the first listed.
NCT03656536 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03656536 about?
NCT03656536 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Chemotherapy in Unresectable or Metastatic Cholangiocarcinoma". The purpose of this study is to evaluate the efficacy and safety of pemigatinib versus gemcitabine plus cisplatin chemotherapy in first-line treatment of participants with unresectable or metastatic cholangiocarcinoma with FGFR2 rearrangement.
What is the current status of trial NCT03656536?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 167 participants. The study started on 2019-06-03. Estimated completion is 2025-07-07.
What interventions are being tested in trial NCT03656536?
The interventions under investigation include: Cisplatin (DRUG), Gemcitabine (DRUG), Pemigatinib (DRUG).
Who is sponsoring clinical trial NCT03656536?
This trial is sponsored by Incyte Corporation, which has 239 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03656536's enrollment target sits among peer trials
167 1463rd of 2000 higher than 538 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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