PROOF Trial: Phase 3 Study of BGJ398 (Oral Infigratinib) in First Line Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations

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
Study Center
Institution Name
QED Therapeutics
State
Country
United States
Website
https://www.qedprooftrial.com/patient/
Study Contacts
Principal Investigator
QED Therapeutics VP Clinical Development
P.I. Phone
(650) 231-4088
P.I. Email
PROOFTrialInfo@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
(650) 231-4088
Study Coordinator Email
PROOFTrialInfo@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 350 participants
Study Start Date
02/28/2019
Estimated Completion Date
10/01/2022
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 , recurrent, or metastatic cholangiocarcinoma with FGFR2 gene fusions/translocations.
Inclusion Criteria – Patients Must:
  • Have histologically or cytologically confirmed unresectable, recurrent or metastatic cholangiocarcinoma with FGFR2 fusion/translocation
Exclusion Criteria – Patients Must NOT:
  • Have received treatment with any systemic anti-cancer therapy for unresectable, recurrent, or metastatic cholangiocarcinoma
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
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