A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of INCB054828 in Subjects With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Including FGFR2 Translocations Who Failed Previous Therapy

  • STATUS
    Recruiting
  • sponsor
    Incyte Corporation
Updated on 25 August 2021

Summary

A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of INCB054828 in Subjects With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Including FGFR2 Translocations Who Failed Previous Therapy
 

Description

The purpose of this study is evaluate the efficacy of INCB054828 in subjects with advanced/metastatic or surgically unresectable cholangiocarcinoma with FGFR2 translocation who have failed at least 1 previous treatment.
 
For more information, please contact Incyte Corporation at 1.855.463.3463 or visit www.incyteclinicaltrials.com

Details
Condition Cholangiocarcinoma
Clinical Study IdentifierTX151145
SponsorIncyte Corporation
Last Modified on25 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Histologically or cytologically confirmed cholangiocarcinoma
Radiographically measurable disease per RECIST v1.1
Documentation of 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
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