| 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)
|
