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

  • STATUS
    Recruiting
  • participants needed
    54
  • sponsor
    Innovent Biologics (Suzhou) Co. Ltd.
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Updated on 19 February 2024
See if I qualify
measurable disease
systemic therapy
cholangiocarcinoma
non-resectable cholangiocellular carcinoma
pemigatinib
FGFR2
non-resectable cholangiocarcinoma

Summary

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

Details
Condition Adenocarcinoma, Adenocarcinoma, Cholangiocarcinoma
Age 18-100 years
Treatment Pemigatinib
Clinical Study IdentifierNCT04256980
SponsorInnovent Biologics (Suzhou) Co. Ltd.
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

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
Clear my responses
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