| Study Name |
| |
PROOF Trial: Phase 3 Study of BGJ398 (Oral Infigratinib) in First Line Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations |
| ClinicalTrials.gov Identifier (if applicable) |
| |
NCT03773302 |
| Clinical Trial Category (check all that apply) |
| |
- First Line Therapy
- Targeted Therapy
|
| Study Center |
| Institution Name |
| |
QED Therapeutics |
| State |
| |
|
| Country |
| |
United States |
| Website |
| |
https://www.qedprooftrial.com/patient/ |
| Study Contacts |
| Principal Investigator |
| |
QED Therapeutics Clinical Development |
| P.I. Phone |
| |
877-280-5655 |
| P.I. Email |
| |
Proof301.ccf@qedtx.com |
| List additional Principal Investigators (include phone number and email) |
| |
Please refer to the PROOF Trial clinicaltrials.gov listing: https://clinicaltrials.gov/ct2/show/NCT03773302 |
| Study Coordinator |
| |
QED Therapeutics Director Clinical Operations |
| Study Coordinator Phone |
| |
877-280-5655 |
| Study Coordinator Email |
| |
Proof301.ccf@qedtx.com |
| List additional Study Coordinators (include phone number and email) |
| |
Please refer to the PROOF Trial clinicaltrials.gov listing: https://clinicaltrials.gov/ct2/show/NCT03773302 |
| OVERVIEW – in layman’s terms (150 words max) |
| |
The PROOF Trial is a global Phase 3 study enrolling patients with advanced/metastatic cholangiocarcinoma who have a FGFR2 gene fusion/translocation. Patients must not have received systemic anti-cancer treatment for advanced disease. Patients are randomized to receive either oral infigratinib (BGJ398) or standard chemotherapy (gem/cis). |
| Enrollment |
| |
Estimated 300 participants |
| Study Start Date |
| |
12/27/2019 |
| Estimated Completion Date |
| |
12/30/2026 |
| Purpose of the Study – in Layman’s Terms (use the “+” to add more list items) |
| |
- The purpose of the PROOF Trial is to evaluate the efficacy and safety of the investigational agent oral infigratinib vs standard of care chemotherapy (gemcitabine plus cisplatin) in first-line treatment of participants with unresectable, locally advanced, or metastatic cholangiocarcinoma with FGFR2 gene fusions/translocations.
|
| Inclusion Criteria – Patients Must: |
| |
- Have histologically or cytologically confirmed unresectable, locally advanced, or metastatic cholangiocarcinoma with FGFR2 fusion/translocation
|
| Exclusion Criteria – Patients Must NOT: |
| |
- Have received treatment with any systemic anti-cancer therapy for unresectable, locally advanced, or metastatic cholangiocarcinoma; however, one cycle of gemcitabin-based chemotherapy is permitted before randomization.
|
| REQUIRED TESTS PRIOR TO BEGINNING STUDY TREATMENT – in layman’s terms |
| |
- Participants have to undergo molecular profiling to determine FGFR2 status. QED will pay for this testing.
|
| POTENTIAL SIDE-EFFECTS – in layman’s terms |
| |
- elevated blood phosphate levels, tiredness, sore mouth, hair thinning
|
