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A Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Chemotherapy in Unresectable or Metastatic Cholangiocarcinoma

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NCT03656536 · results posted

Sponsored by Incyte Corporation (industry) · INCY — their whole pipeline →.

Phase
Phase 3
Status
Terminated
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
167actual
Sites
215
Countries
Austria, Belgium, Canada +16

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Why the sponsor stopped it

The study was terminated due to lack of enrollment resulting from a change in the standard of care for the first-line treatment of patients with cholangiocarcinoma. There were no safety concerns that contributed to this decision.

As filed on the registry record, in the sponsor's own words.

Dates

each axis at the precision it was filed, with the registry's own basis
DateFiledBasisWhat it is
Start2019-06-03actualWhen the study began enrolling
Primary completion2025-07-07actualThe date the last participant is measured for the primary outcome — the readout window
Study completion2025-07-07actualThe whole study's end, after follow-up
First posted2018-09-04actualWhen this record first appeared on the registry
Results posted2026-08-11actualWhen the sponsor posted results to the registry
Record updated2026-08-11actualThe sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Conditions

  • Unresectable Cholangiocarcinoma
  • Metastatic Cholangiocarcinoma

Interventions

  • Drug: Pemigatinib — also filed as INCB054828
  • Drug: Gemcitabine
  • Drug: Cisplatin

Primary outcomes

what the primary-completion date above is the date OF
Randomized Treatment Period: Progression-free Survival (PFS)
measured up to 1422 days
Randomized Treatment Period: Kaplan-Meier Estimates of PFS of the Indicated Lengths of Time
measured up to 1422 days
Transition Period: PFS
measured up to 1496 days
Transition Period: Kaplan-Meier Estimates of PFS of the Indicated Lengths of Time
measured up to 1496 days

Posted documents

hosted by the registry — we link, never re-serve
Study Protocolposted 2024-06-18 · 1.1 MB · Prot_000.pdf
Statistical Analysis Planposted 2025-06-10 · 624 KB · SAP_001.pdf

Publications

Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.

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