| ClinicalTrials.gov Identifier |
| NCT03773302 |
| Institution Name |
| QED Therapeutics |
| Institution Country |
| United States |
| Institution Website |
| https://www.qedprooftrial.com/patient/ |
| Principal Investigator |
| QED Therapeutics Clinical Development |
| Principal Investigator Phone |
| 877-280-5655 |
| Principal Investigator Email |
| Proof301.ccf@qedtx.com |
| Additional Principal Investigators |
| 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 |
| Additional Study Coordinators |
| Please refer to the PROOF Trial clinicaltrials.gov listing: https://clinicaltrials.gov/ct2/show/NCT03773302 |
| Study Overview |
| 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 Information |
| Estimated 300 participants |
| Study Start Date |
| 20191227 |
| Study End Date |
| 20261230 |
| Study Purpose |
| 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 |
| Have histologically or cytologically confirmed unresectable, locally advanced, or metastatic cholangiocarcinoma with FGFR2 fusion/translocation |
| Exclusion Criteria |
| 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 Study |
| Participants have to undergo molecular profiling to determine FGFR2 status. QED will pay for this testing. |
| Potential Side Effects |
| elevated blood phosphate levels, tiredness, sore mouth, hair thinning |
| Financial Assistance Available |
| Yes |
