A Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma With FGFR2 Fusion or Rearrangements After at Least 1 Prior Line of Systemic Therapy

Korábbi kezelés

• Prior treatment with any FGFR inhibitor for any indication.
• Use of strong CYP3A4 inhibitors and inducers, moderate CYP3A4 inducers, and concomitant FGFR inhibitor, investigational drug and anticancer medication other than pemigatinib.

Más betegség

• Known CNS metastases or history of uncontrolled seizures, except participants with treated brain metastases and no evidence of progression for => 4 weeks and on stable or decreasing dose of corticosteroids for management of CNS metastases for =>1 week.
• History of hypovitaminosis D requiring supraphysiologic doses (eg, 50,000 UI/week) to replenish the deficiency.
• Clinically significant or uncontrolled cardiac disease or history or presence of an abnormal ECG, which, in the investigator's opinion, is clinically meaningful.

Laborértékek

• History of calcium and phosphate hemostasis disorder or systemic mineral imbalance with ectopic calcification of soft tissues.

Egyéb

• Liver cirrhosis, Child-Pugh B and C.
• Current evidence of clinically significant corneal or retinal as confirmed by ophthalmologic examination.
• Women who are pregnant or breastfeeding.
  • Other protocol-defined inclusion/exclusion criteria apply.

• Histologically or cytologically confirmed unresectable, locally advanced or metastatic cholangiocarcinoma (CCA).
• Documented FGFR2 fusion or rearrangement
• Documented disease progression after at least 1 prior line of systemic chemotherapy, with or without immune checkpoint inhibitors (ICI).
• Life expectancy ≥ 12 weeks.
• An ECOG performance status of 0 to 1.
• Measurable disease by CT or MRI based on RECIST v1.1 as determined by site radiology.
• Willingness to avoid pregnancy or fathering children.