Efficacy and Safety of Pemigatinib in Subjects With Advanced/Metastatic or Surgically Unresectabl… (NCT02924376) | Clinical Trial Compass
CompletedPhase 2
Efficacy and Safety of Pemigatinib in Subjects With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Who Failed Previous Therapy - (FIGHT-202)
United States147 participantsStarted 2017-01-16
Plain-language summary
The purpose of this study is evaluate the efficacy of pemigatinib in subjects with advanced/metastatic or surgically unresectable cholangiocarcinoma with FGFR2 translocation who have failed at least 1 previous treatment.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Histologically or cytologically confirmed cholangiocarcinoma.
* Radiographically measurable or evaluable disease per RECIST v1.1.
* Tumor assessment for FGF/FGFR gene alteration status.
* Documented disease progression after at least 1 line of prior systemic therapy.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
* Life expectancy ≥ 12 weeks.
Exclusion Criteria:
* Prior receipt of a selective FGFR inhibitor.
* History of and/or current evidence of ectopic mineralization/calcification, including but not limited to soft tissue, kidneys, intestine, myocardia, or lung, excepting calcified lymph nodes and asymptomatic arterial or cartilage/tendon calcifications.
* Current evidence of clinically significant corneal or retinal disorder confirmed by ophthalmologic examination.
* Use of any potent CYP3A4 inhibitors or inducers within 14 days or 5 half-lives, whichever is shorter, before the first dose of study drug. Topical ketoconazole will be allowed.
What they're measuring
1
Objective Response Rate (ORR) in Participants With FGFR2 Rearrangements or Fusions