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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
167
Pemigatinib at the protocol-defined dose administered orally once daily as continuous therapy schedule (a cycle is 3 weeks).
Gemcitabine 1000 mg/m\^2 administered as an intravenous infusion on Days 1 and 8 of every 3-week cycle for up to 8 cycles.
Cisplatin 25 mg/m\^2 administered as an intravenous infusion on Days 1 and 8 of every 3-week cycle for up to 8 cycles.
Progression-free survival
Defined as the time from date of randomization until date of disease progression (according to Response Evaluation Criteria in Solid Tumors \[RECIST\] v1.1 and assessed by an independent central reviewer (ICR)) or death, whichever occurs first.
Time frame: Up to approximately 12 months
Overall response rate
Defined as the proportion of participants with best overall response of complete response (CR) or partial response (PR) per RECIST v1.1 as assessed by an ICR.
Time frame: Up to approximately 12 months
Overall survival
Defined as the time from date of randomization until death due to any cause.
Time frame: Up to approximately 12 months
Duration of response
Defined as the time from the date of the first assessment of CR or PR until the date of the first disease progression by an ICR per RECIST v1.1 or death, whichever occurs first.
Time frame: Up to approximately 12 months
Disease control rate
Defined as the proportion of participants who achieved best overall response of CR, PR, or stable disease (SD) per RECIST v1.1 as assessed by an ICR.
Time frame: Up to approximately 12 months
Number of treatment-emergent adverse events
Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug.
Time frame: Up to approximately 12 months
Quality of Life impact as assessed by the EQ-5D-3L questionnaire
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Mayo Clinic Arizona
Phoenix, Arizona, United States
Marin Cancer Care
Greenbrae, California, United States
UC Irvine Medical Center
Orange, California, United States
Georgetown University-Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, United States
Mayo Clinic-Florida
Jacksonville, Florida, United States
Mount Sinai Medical Center Comprehensive Cancer Center
Miami Beach, Florida, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Parkview Research Center
Fort Wayne, Indiana, United States
University of Iowa Hospital and Clinics
Iowa City, Iowa, United States
...and 205 more locations
Time frame: Up to 12 months
Quality of Life impact as assessed by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-30 questionnaire
Time frame: Up to 12 months
Quality of Life impact as assessed by the EORTC QLQ-BIL21 questionnaire
Time frame: Up to 12 months