A Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Chemotherapy in Unresectable or Metastatic Cholangiocarcinoma
Clinicaltrials.gov ID
NCT03656536
Status
Recruiting
Study Type
Interventional, Phase 3
Sponsor
Incyte Corporation
Start Date
June 2, 2019
Anticipated End Date
October 25, 2027
Study Contact
About the Study
The purpose of this study is to evaluate the efficacy and safety of pemigatinib versus gemcitabine plus cisplatin chemotherapy in first-line treatment of participants with unresectable or metastatic cholangiocarcinoma with FGFR2 rearrangement.
Conditions
Unresectable Cholangiocarcinoma
Metastatic Cholangiocarcinoma
Inclusion/Exclusion Criteria?
Primary, Secondary, Other Outcome Measures??
Locations in Canada
Tom Baker Cancer Centre, Calgary, Alberta, T2N 4N2, Canada (not yet recruiting)
Cancercare Manitoba, Winnipeg, Manitoba, R3E 0V9, Canada (not yet recruiting)
Nova Scotia Health Authority/QEII Health Sciences Centre, Halifax, Nova Scotia, B3H 4K4, Canada
Princess Margaret Cancer Center, Toronto, Ontario, MG5 2M9, Canada
McGill University Health Centre Research Institute, Montreal, Quebec, H4A 3J1, Canada (not yet recruiting)
About the Study
The purpose of this study is to evaluate the efficacy and safety of pemigatinib versus gemcitabine plus cisplatin chemotherapy in first-line treatment of participants with unresectable or metastatic cholangiocarcinoma with FGFR2 rearrangement.
Conditions
Unresectable Cholangiocarcinoma
Metastatic Cholangiocarcinoma
Interventions
DRUG:
Pemigatinib
Gemcitabine
Cisplatin
Locations in Canada
Tom Baker Cancer Centre, Calgary, Alberta, T2N 4N2, Canada (not yet recruiting)
Cancercare Manitoba, Winnipeg, Manitoba, R3E 0V9, Canada (not yet recruiting)
Nova Scotia Health Authority/QEII Health Sciences Centre, Halifax, Nova Scotia, B3H 4K4, Canada
Princess Margaret Cancer Center, Toronto, Ontario, MG5 2M9, Canada
McGill University Health Centre Research Institute, Montreal, Quebec, H4A 3J1, Canada (not yet recruiting)