NCT02508467

A Phase 1 Study of Fisogatinib (BLU-554) in Patients With Hepatocellular Carcinoma

A Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of BLU-554 in Patients With Hepatocellular Carcinoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 146 (actual)
• Sponsor: Blueprint Medicines Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatocellular Carcinoma (HCC)

Interventions

Type	Name	Description
DRUG	Fisogatinib (BLU-554)

Timeline

• Start date: 2015-07-31
• Primary completion: 2021-06-30
• Completion: 2024-02-28
• First posted: 2015-07-27
• Last updated: 2024-04-12

Locations

41 sites across 12 countries: United States, China, France, Germany, Hong Kong, Italy, Singapore, South Korea, Spain, Switzerland, Taiwan, United Kingdom