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

NCT02508467 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2024-04-12

No results posted yet for this study

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

DRUG

Fisogatinib (BLU-554)

Sponsors & Collaborators

  • Blueprint Medicines Corporation

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2021-06-30
Completion
2024-02-28

Countries

  • United States
  • China
  • France
  • Germany
  • Hong Kong
  • Italy
  • Singapore
  • South Korea
  • Spain
  • Switzerland
  • Taiwan
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02508467 on ClinicalTrials.gov