A Phase 1 Study of Fisogatinib (BLU-554) in Patients With Hepatocellular Carcinoma
NCT ID: NCT02508467
Last Updated: 2024-04-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
146 participants
INTERVENTIONAL
2015-07-31
2024-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Fisogatinib (BLU-554)
Fisogatinib (BLU-554) capsules for oral administration.
Fisogatinib (BLU-554)
Interventions
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Fisogatinib (BLU-554)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* For Part 1 and 2, the patient has unresectable disease and has been previously treated with sorafenib, has declined treatment with sorafenib, or does not have access to sorafenib.
* For Part 3, the patient has not received prior treatment with a TKI.
* Child-Pugh class A with no clinically apparent ascites
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* For Part 1, willing to provide archived tumor tissue (if available) and willing to undergo pre- and on-treatment tumor biopsy (if considered safe and medically feasible by the treating investigator)
* For Part 2 and 3, all patients must have an FGF19 IHC result available. Only FGF19 IHC+ HCC patients will be eligible for Part 3.
Exclusion Criteria
* Platelet count \<75,000/mL
* Absolute neutrophil count \<1000/mL
* Hemoglobin \<8 g/dL
* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>5x the upper limit of normal (ULN)
* Total bilirubin \>2.5 mg/dL
* International normalized ratio (INR) \>2.3 or prothrombin time (PT) \>6 seconds above control
* Estimated (Cockroft-Gault formula) or measured creatinine clearance \<40 mL/min
18 Years
ALL
No
Sponsors
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Blueprint Medicines Corporation
INDUSTRY
Responsible Party
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Locations
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Inland Empire Liver Foundation
Rialto, California, United States
University of Miami - Sylvester Comprehensive Cancer Center
Miami, Florida, United States
H. Lee Moffitt Cancer Center
Tampa, Florida, United States
Ochsner Cancer Institute
New Orleans, Louisiana, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Mount Sinai Medical Center
New York, New York, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Zhejiang Cancer Hospital
Hangzhou, Gongshu District, China
Nanfang Hospital
Guangzhou, Guangdong, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Hunan Cancer Hospital, Radioactive Interventional Department
Changsha, Hunan, China
The Chinese People's Liberation Army 81 Hospital
Nanjing, Jiangsu, China
Nantong Tumor Hospital
Nantong, Jiangsu, China
Jilin Cancer Hospital
Changchun, Jilin, China
Jilin University the First Affiliated Hospital
Changchun, Jilin, China
Fudan University Zhongshan Hospital
Xuhui, Shanghai City, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute & Hospital, Hepatobiliary Oncology Department
Tianjin, West Lake District, China
Fudan University Shanghai Cancer Center
Shanghai, Xuhui District, China
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Hospital Beaujon
Clichy, , France
Institut Gustave Roussy
Villejuif, , France
Johannes Gutenberg University Mainz - University Medical Center
Mainz, Rhineland-Palatine, Germany
University of Frankfurt
Frankfurt, , Germany
Prince of Wales Hospital
Hong Kong, , Hong Kong
Queen Mary Hospital
Hong Kong, , Hong Kong
IRCCS Foundation - National Institute of Tumors
Milan, , Italy
National Cancer Centre
Singapore, , Singapore
National Cancer Center
Gyeonggi-do, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Vall d'Hebron Institute of Oncology
Barcelona, , Spain
Inselspital Bern
Bern, , Switzerland
National Cheng Kung University Hospital
Tainan City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
University of Liverpool - Clatterbridge Cancer Centre
Bebington, , United Kingdom
Royal Free Hospital
London, , United Kingdom
Guy's Hospital
London, , United Kingdom
University College London
London, , United Kingdom
Countries
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Other Identifiers
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2015-001662-26
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
BLU-554-1101
Identifier Type: -
Identifier Source: org_study_id
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