A Phase 1 Study of Fisogatinib (BLU-554) in Patients With Hepatocellular Carcinoma
Completed · Phase 1
Conditions studied: Hepatocellular Carcinoma (HCC)
In brief
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.
Key facts
- Study ID
- NCT02508467
- Run by
- Blueprint Medicines Corporation
- People needed
- 146
- Starts
- 2015-07-31
- Expected to finish
- 2024-02-28
- Last updated by the study team
- 2024-04-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- 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
Full record on ClinicalTrials.gov
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