Spots Global Cancer Trial Database for A Phase 1 Study of Fisogatinib (BLU-554) in Patients With Hepatocellular Carcinoma
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Trial Identification
Brief Title: A Phase 1 Study of Fisogatinib (BLU-554) in Patients With Hepatocellular Carcinoma
Official Title: A Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of BLU-554 in Patients With Hepatocellular Carcinoma
Study ID: NCT02508467
Conditions
Interventions
Study Description
Brief Summary: This is a Phase 1, open-label, first-in-human (FIH) study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antineoplastic activity of fisogatinib (formerly known as BLU- 554) administered orally in patients with FGF19 IHC+ hepatocellular carcinoma (HCC). The study consists of 3 parts, a dose-escalation part (Part 1), an expansion part (Part 2) exploring a once daily (qd) dosing schedule at the recommended Phase 2 dose (RP2D), and a Part 3 expansion of the qd dosing schedule at the RP2D in TKI naive patients.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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 Center, Gyeonggi-do, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
National Cancer Centre, Singapore, , Singapore
Vall d'Hebron Institute of Oncology, Barcelona, , Spain
Inselspital Bern, Bern, , Switzerland
National Cheng Kung University Hospital, Tainan, , 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
Contact Details
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