A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of INCB054828 in Subjects With AdvancedCholangiocarcinoma Including FGFR2 Translocations Who Failed Previous Therapy

Phase 1

• Conditions: Subjects with advanced/metastatic or surgically unresectable cholangiocarcinoma with FGFR2 translocations, with other FGF/FGFR alterations, or who are negative for any FGF/FGFR alterations, who failed at least 1 previous treatment.; MedDRA version: 20.0Level: PTClassification code 10008593Term: CholangiocarcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-002422-36-GB
• Lead Sponsor: Incyte Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-08-01
• Last Update Posted: 22 June 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• Men and women, aged 18 or older.
• Histologically or cytologically confirmed advanced/metastatic or surgically unresectable cholangiocarcinoma. Subjects will be assigned to 1 of 3 cohorts:
a. Cohort A: FGFR2 translocations with a documented fusion partner in central laboratory report.
b. Cohort B: other FGF/FGFR alterations.
c. Cohort C (US only): negative for FGF/FGFR alterations.
• 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.
• ECOG performance status of 0 to 2.
• Life expectancy = 12 weeks.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified