Clinical Trials List
2017-04-18 - 2020-02-01
Phase II
Terminated4
ICD-10C22.0
Liver cell carcinoma
ICD-10C22.1
Intrahepatic bile duct carcinoma
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
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Trial Applicant
IQVIA RDS Taiwan Ltd.
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Sponsor
Incyte Corporation
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Audit
None
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 劉奕廷 無
- Yan-Shen Shan 無
- Shang-Yin Wu 無
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Audit
None
Co-Principal Investigator
Audit
None
Co-Principal Investigator
- Ann-Lii Cheng 無
- 張端瑩 無
- 呂理駿 無
- Chiun Hsu 無
- SHIH-HUNG YANG 未分科
- SHIH-HUNG YANG 無
- Kun-Huei Yeh 無
- TA-CHEN HUANG 無
- 王秀伯 無
- 林育麟 無
- YU-YUN SHAO 無
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Audit
None
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
The primary endpoint of this study is to determine the objective response rate (ORR) in subjects with
FGFR2 translocations. Objective response rate is defined as the proportion of subjects who achieved a
complete response (CR; disappearance of all target lesions) or a partial response (PR; >30% decrease in
the sum of the longest diameters of target lesions) based on RECIST version 1.1. Clinical response will
be determined by an independent radiological review committee.
Secondary Endpoints:
• ORR in subjects with fibroblast growth factor (FGF)/FGFR alterations other than FGFR2 translocations
(Cohort B).
• ORR in all subjects with FGF/FGFR alterations (Cohorts A and B).
• ORR in subjects negative for FGF/FGFR alterations (Cohort C).
• Progression-free survival (PFS = first dose to progressive disease [PD] or death; all cohorts).
• Duration of response (DOR = time from the date of CR or PR until PD; all cohorts).
• Disease control rate (DCR = CR + PR + stable disease; all cohorts).
• Overall survival (OS = first dose to death of any cause; all cohorts).
• Safety and tolerability will be assessed by evaluating the frequency, duration, and severity of adverse
events; through review of findings of physical examinations, changes in vital signs, and
electrocardiograms; and through clinical laboratory blood and urine sample evaluations (all cohorts).
• Population pharmacokinetics (all cohorts).
Inclution Criteria
• Men and women, aged 18 or older.
• Histologically or cytologically confirmed cholangiocarcinoma.
• Radiographically measurable or evaluable disease per RECIST v1.1.
• Tumor assessment for FGF/FGFR gene alteration status completed through the central laboratory.
• Documented disease progression after at least 1 line of prior systemic therapy.
• 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 corneal disorder/keratopathy, including but not limited to bullous/band keratopathy, corneal abrasion, inflammation/ulceration, keratoconjunctivitis, etc, 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.
The Estimated Number of Participants
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Taiwan
15 participants
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Global
100 participants
