A Phase 3, First Line Study of Pemigatinib vs Gemcitabine/Cisplatin in Patients with Cholangiocarcinoma

ClinicalTrials.gov Identifier

NCT03656536

Institution Name

Incyte Corporation

Institution Address (Street)

1815 Augustine Cut Off

Institution City

Wilmington

Institution State

Delaware

Institution ZIP Code

19803

Institution Country

United States

Institution Phone

(855) 463-3463

Principal Investigator

Tanios Bekaii-Saab, MD

Principal Investigator Phone

(855) 463-9463

Additional Principal Investigators

Please refer to the Clinical Trials. gov listing and contact the Incyte Help Line at 855-463-3463 for a site list

Study Coordinator Phone

(855) 463-3463

Additional Study Coordinators

Please refer to the Clinical Trials. gov listing and contact the Incyte Help Line at 855-463-3463 for a site list

Study Overview

This is a phase 3, first line treatment in patients with cholangiocarcinoma who have not received previous treatment and are FGFR2 rearrangement positive. This is a comparative study of pemigatinib (FGFR inhibitor) versus gemcitabine and cisplatin.

Enrollment Information

Estimated for 432

Study Start Date

20181214

Study End Date

20211119

Study Purpose

The purpose of the study is to determine how well pemigatinib (study drug) works in patients with cholangiocarcinoma in first line versus gemcitabine/cisplatin

Inclusion Criteria

Have an FGFR2 rearrangement

Exclusion Criteria

Have received a prior treatment (first line)

Required Tests Prior to Study

Patients must undergo genomic sequencing to determine FGFR status. Incyte will pay for this testing.

Potential Side Effects

Loose stools, tiredness, hair thinning, dry mouth

Financial Assistance Available

No