A Phase 2 Open-Label Study in Patients with Cholangiocarcinoma

By CCF Clinical Trials | April 18, 2017

Study Name
	A Phase 2 Open-Label Study in Patients with Cholangiocarcinoma
ClinicalTrials.gov Identifier (if applicable)
	NCT02924376
Study Center
Institution Name
	Incyte Corporation
Institution Address
	1801 Augustine Cut-Off
City
	Wilmington
State
	Delaware
Zip Code
	19803
Phone
	(855) 463-3463
Study Contacts
Principal Investigator
	A lead investigator has not been identified yet (TBD)
P.I. Phone
	(855) 463-3463
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 research center near you.
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 research center near you.
OVERVIEW – in layman’s terms (150 words max)
	This is an open-label (both the patient and the investigator know what the patient is receiving), Phase 2 study in patient with cholangiocarcinoma who have failed at least one prior line of therapy.
Enrollment
	140
Study Start Date
	11/15/2016
Estimated Completion Date
	08/2018
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 INCB054828 (study drug) works in patients with cholangiocarcinoma, with and without an FGF/FGFR alteration
Inclusion Criteria – Patients Must:
	Patients must be willing to undergo a biopsy or have sufficient archival tissue that is less than 2 years old and submit for genomic testing
REQUIRED TESTS PRIOR TO BEGINNING STUDY TREATMENT – in layman’s terms
	Tumor tissue will be submitted to the central laboratory for genomic sequencing (looking for genetic abnormalities in the tumor tissue only)