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

Study Name
A Phase 3, First Line Study of Pemigatinib vs Gemcitabine/Cisplatin in Patients with Cholangiocarcinoma
ClinicalTrials.gov Identifier (if applicable)
NCT03656536
Clinical Trial Category (check all that apply)
  • First Line Therapy
Study Center
Institution Name
Incyte Corporation
Institution Address
1815 Augustine Cut Off
City
Wilmington
State
Delaware
Zip Code
19803
Country
United States
Phone
(855) 463-3463
Study Contacts
Principal Investigator
Tanios Bekaii-Saab, MD
P.I. Phone
(855) 463-9463
P.I. Email
TBD@XYZ.com
List additional Principal Investigators (include phone number and email)
Please refer to the Clinical Trials. gov listing and contact the Incyte Help Line at 855-463-3463 for a site list
Study Coordinator
TBD
Study Coordinator Phone
(855) 463-3463
Study Coordinator Email
TBD@XYZ.com
List additional Study Coordinators (include phone number and email)
Please refer to the Clinical Trials. gov listing and contact the Incyte Help Line at 855-463-3463 for a site list
OVERVIEW – in layman’s terms (150 words max)
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
Estimated for 432
Study Start Date
12/14/2018
Estimated Completion Date
11/19/2021
Purpose of the Study – in Layman’s Terms (use the “+” to add more list items)
  • 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 – Patients Must:
  • Have an FGFR2 rearrangement
Exclusion Criteria – Patients Must NOT:
  • Have received a prior treatment (first line)
REQUIRED TESTS PRIOR TO BEGINNING STUDY TREATMENT – in layman’s terms
  • Patients must undergo genomic sequencing to determine FGFR status. Incyte will pay for this testing.
POTENTIAL SIDE-EFFECTS – in layman’s terms
  • Loose stools, tiredness, hair thinning, dry mouth
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