A Phase 2 Open-Label Study in Patients with Cholangiocarcinoma

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)
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