Inclusion Criteria:
- Histologically or cytologically confirmed unresectable locally advanced or metastatic
cholangiocarcinoma. Participants with gallbladder cancer or ampulla of Vater carcinoma
are not eligible
- Documented FGFR2 gene fusions/translocations
- Have an archival tissue sample available with sufficient tumor for central FGFR2
fusion/translocation molecular testing. However, if an archival tissue sample is not
available, a newly obtained (before randomization) tumor biopsy may be submitted
instead.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Able to swallow and retain oral medication
- Willingness to avoid pregnancy or father children
Exclusion Criteria:
- Received treatment with any systemic anti-cancer therapy for unresectable locally
advanced or metastatic cholangiocarcinoma. Prior neoadjuvant or adjuvant therapy is
permitted if completed > 6 months after the last dose of neoadjuvant or adjuvant
therapy.
- History of a liver transplant
- Received previously or currently is receiving treatment with a mitogen activated
protein kinase kinase (MEK) or selective FGFR inhibitor
- Have impairment of gastrointestinal (GI) function or GI disease that may significantly
alter the absorption of oral infigratinib (such as, ulcerative diseases, uncontrolled
nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection).
- Current evidence of endocrine alterations of calcium/phosphate homeostasis, e.g.,
parathyroid disorders, history of parathyroidectomy, tumor lysis, tumoral calcinosis
etc.
- History and/or current evidence of extensive tissue calcification including, but not
limited to, the soft tissue, kidneys, intestine, myocardium, vascular system and lung
with the exception of calcified lymph nodes, minor pulmonary parenchymal
calcifications, and asymptomatic coronary calcification
- Current evidence of corneal or retinal disorder/keratopathy
- Receiving and continued treatment or are planning to receive agents or consuming foods
that are known strong inducers or inhibitors of CYP3A4 and medications which increase
serum phosphorus and/or calcium concentration
- Clinically significant or uncontrolled cardiac disease
- Recent (≤ 3 months prior to first dose of study drug) transient ischemic attack or
stroke
- Severe hearing loss
- Severe neuropathy
- History of another primary malignancy within 3 years except adequately treated in-situ
carcinoma of the cervix or non-melanoma skin cancer or other curatively treated
malignancy that is not expected to require treatment
- Pregnant or breastfeeding
- Have known microsatellite instability-high (MSI-H) disease and the decision is made by
the treating investigator that an alternative, non-study therapy is warranted
according to standard of care.
- Have any known hypersensitivity to gemcitabine, cisplatin, calcium-lowering agents,
infigratinib, or their excipients
