Pemigatinib in Treating Patients With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Including FGFR2 Rearrangement

Innovent Biologics

Status and phase

Completed

Phase 2

Conditions

Cholangiocarcinoma

Treatments

Drug: Pemigatinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT04256980

CIBI375A201

Details and patient eligibility

About

This is a phase 2 study to investigate the efficacy and safety of Pemigatinib in treating patients with advanced/metastatic or surgically unresectable cholangiocarcinoma with FGFR2 rearrangement who have failed at least 1 previous therapy

Enrollment

34 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Men and women, aged 18 or older.
Histologically or cytologically confirmed cholangiocarcinoma which was considered to be advanced/metastatic or surgically unresectable by the investigator through image examination.
Radiographically measurable disease per RECIST v 1.1
Documentation of FGFR2 rearrangement.
Documented disease progression after at least 1 line of prior systemic therapy.
ECOG performance status of 0~1.
Life expectancy ≥12 weeks.

Exclusion criteria

Prior receipt of a selective FGFR inhibitor.
History of calcium and phosphate hemostasis disorder or systemic mineral imbalance with ectopic calcification of softy tissues ( exception: skin, kidney, tendons or vessels due to injury, disease, and aging, in the absence of systemic mineral imbalance).
Currently 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.