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NCT02508467 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by Blueprint Medicines Corporation.

Completed
Registry status
Phase 1
Development phase
146
Enrollment target

NCT02508467: Completed Phase 1 study, sponsored by Blueprint Medicines Corporation.

NCT02508467 is a Phase 1 study that has completed, run by Blueprint Medicines Corporation. The registered enrollment target is 146 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (143% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02508467, a Phase 1 study, has completed, sponsored by Blueprint Medicines Corporation.

COMPLETED
Registry status
Phase 1
Development phase
146 participants
Enrollment target

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.

Interventions

  • DRUG Fisogatinib (BLU-554)

Trial Details

FieldValue
Enrollment Target 146 participants
Start Date 2015-07-31
Est. Completion 2024-02-28
Phase Phase 1
Blueprint Medicines Corporation

24 total trials

What the finished NCT02508467 record still lists

NCT02508467 is an interventional study that assigns participants to a tested intervention. The registered 146 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (143% higher).

The record links to 0 conditions, and to 1 intervention - of which Fisogatinib (BLU-554) is the first listed.

NCT02508467 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02508467 about?

NCT02508467 is a clinical study titled "A Phase 1 Study of Fisogatinib (BLU-554) in Patients With Hepatocellular Carcinoma". 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 ca...

What is the current status of trial NCT02508467?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 146 participants. The study started on 2015-07-31. Estimated completion is 2024-02-28.

What interventions are being tested in trial NCT02508467?

The interventions under investigation include: Fisogatinib (BLU-554) (DRUG).

Who is sponsoring clinical trial NCT02508467?

This trial is sponsored by Blueprint Medicines Corporation, which has 24 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02508467's enrollment target sits among peer trials

146 391st of 2000 higher than 1,610 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02508467, the US trial registry maintained by the National Library of Medicine. NCT02508467 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.