| 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) |
|
|
| 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
|
