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 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