Efficacy and Safety of Pemigatinib in Subjects With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Who Failed Previous Therapy - (FIGHT-202)

Incyte

Status and phase: Completed; Phase 2

Conditions: Cholangiocarcinoma

Treatments: Drug: Pemigatinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT02924376

2016-002422-36 (EudraCT Number)

INCB 54828-202

Details and patient eligibility

About

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.

Enrollment: 147 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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147 participants in 3 patient groups

Cohort A Pemigatinib

Experimental group

Description:

Pemigatinib in subjects with FGFR2 translocation with a documented fusion partner in central laboratory report

Treatment:

Drug: Pemigatinib

Cohort B Pemigatinib

Experimental group

Description:

Pemigatinibin subjects with other FGF/FGFR alterations

Treatment:

Drug: Pemigatinib

Cohort C Pemigatinib

Experimental group

Description:

Pemigatinib in subjects negative for FGF/FGFR alteration

Treatment:

Drug: Pemigatinib