Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 1 study that has completed, run by Blueprint Medicines Corporation. The registered enrollment target is 146 participants.
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
| Field | Value |
|---|---|
| Enrollment Target | 146 participants |
| Start Date | 2015-07-31 |
| Est. Completion | 2024-02-28 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02508467
The ClinicalTrials.gov registry entry for NCT02508467 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 146 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Blueprint Medicines Corporation, which has 24 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Fisogatinib (BLU-554) is the first listed.
NCT02508467 reports 0 study locations.
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.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.