Patients with unresectable or metastatic cholangiocarcinoma:
• No systemic therapy for metastatic disease
• FGFR2 fusion or rearrangement
• ECOG PS 0–1
Stratified by:
• Locally advanced vs metastatic disease
• Geographic region
• Adjuvant/neoadjuvant treatment (yes/no)
Enrollment
Infigratinib monotherapy
(125 mg once daily × 21 days every 28 days)
Gemcitabine (1,000 mg/m² ) plus cisplatin (25 mg/m²) on days 1 and 8 every 21 days
Treatment given until radiographic
progressive disease (centrally assessed)
Optional crossover to
infigratinib permitted
Treatment
Endpoints
Primary endpoint
• Progression-free survival (by BICR)
Secondary endpoints
• Overall survival
• Progression-free survival (investigator assessed)
• Objective response rate*
• Best overall response*
• Duration of response*
• Disease control rate*
• Safety/tolerability
Exploratory endpoints
• Quality of life
• Pharmacokinetics
• Correlation between coexisting mutations and clinical endpoints
Randomize
2:1
(one cycle of gemcitabine-based chemotherapy is
permitted before randomization)