Protocol Summary

Protocol No.: OCR15234

Sponsor Protocol No.: INCB 54828-202

Study Title
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

Principal Investigator(s)
George, Thomas

Objective
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.

Phase: Phase II

Age Group: Adult

Scope: National

Treatment
Cohort A INCB054828
INCB054828 once daily in subjects with FGFR2 translocation

Cohort B INCB054828
INCB054828 once daily in subjects with other FGF/FGFR alterations

Cohort C INCB054828
INCB054828 once daily in subjects negative for FGF/FGFR alteration

Detailed Eligibility
INCLUSION CRITERIA:
1. Ages 18 years old and older
2. Histologically or cytologically confirmed cholangiocarcinoma.
3. Radiographically measurable or evaluable disease per RECIST v1.1.
4. Tumor assessment for FGF/FGFR gene alteration status.
5. Documented disease progression after at least 1 line of prior systemic therapy.
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
7. Life expectancy >= 12 weeks.

EXCLUSION CRITERIA:
1. Prior receipt of a selective FGFR inhibitor.
2. 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.
3. Current evidence of clinically significant corneal or retinal disorder confirmed by ophthalmologic examination.
4. 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.

Applicable Disease Sites
Gastrointestinal Cancer

Participating Institutions
UF Gainesville : Margaret Veal

Contact
Margaret Veal
Phone: +1 352-265-0680 ext. 87656

Email: mamcewan@ufl.edu

More Information:
View study listing on ClinicialTrials.gov
http://www.clinicaltrials.gov/ct2/show/
NCT02924376