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NCT07862998
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
Conditions: Unresectable Cholangiocarcinoma, Advanced/Metastatic Cholangiocarcinoma
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 72
Sponsor: Incyte Corporation
Summary
The purpose of this study is to confirm 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.
Eligibility Criteria
Inclusion Criteria:
* 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.
Exclusion Criteria:
* Prior treatment with any FGFR inhibitor for any indication.
* Liver cirrhosis, Child-Pugh B and C.
* 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.
* Current evidence of clinically significant corneal or retinal as confirmed by ophthalmologic examination.
* History of calcium and phosphate hemostasis disorder or systemic mineral imbalance with ectopic calcification of soft tissues.
* 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.
* Use of strong CYP3A4 inhibitors and inducers, moderate CYP3A4 inducers, and concomitant FGFR inhibitor, investigational drug and anticancer medication other than pemigatinib.
* Women who are pregnant or breastfeeding.
Other protocol-defined inclusion/exclusion criteria apply.
Source: ClinicalTrials.gov (NCT07862998). StuddyBuddy aggregates publicly available trial information.