Protocol No.: OCR15234
Sponsor Protocol No.: INCB 54828-202
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
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
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
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.
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
UF Gainesville : Margaret Veal
Phone: +1 352-265-0680 ext. 87656
View study listing on ClinicialTrials.gov