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Kinase Inhibitor

Fisogatinib for Liver Cancer

Phase 1
Waitlist Available
Research Sponsored by Blueprint Medicines Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every cycle (28 days) up to cycle 4 and at end of treatment (approximately 24 months or earlier if patient terminates from the study)
Awards & highlights

Study Summary

This trial is testing a new cancer drug, fisogatinib, to see if it is safe and effective in patients with hepatocellular carcinoma (HCC). The study will consist of 3 parts, with increasing doses of the drug in the first part, followed by testing of a once-daily dose in the second part, and finally testing in patients who have not received any other cancer treatments in the third part.

Who is the study for?
This trial is for adults with a confirmed diagnosis of hepatocellular carcinoma (HCC), which is a type of liver cancer. Participants must have tried, declined, or lack access to the drug sorafenib unless they're in Part 3 where no prior treatment with TKI drugs is allowed. They should be relatively healthy otherwise, with good liver function and blood counts.Check my eligibility
What is being tested?
The study tests Fisogatinib (BLU-554) on patients with HCC who test positive for FGF19 protein. It's given orally in increasing doses to find safe levels (Part 1), then at an established dose daily (Parts 2 & 3). The goal is to see how well it works and how the body handles it.See study design
What are the potential side effects?
While specific side effects aren't listed here, Phase I trials like this one are looking out for any adverse reactions ranging from mild symptoms like nausea or fatigue to more serious issues affecting organ function or blood cell counts.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every cycle (28 days) up to cycle 4 and at end of treatment (approximately 24 months or earlier if patient terminates from the study)
This trial's timeline: 3 weeks for screening, Varies for treatment, and every cycle (28 days) up to cycle 4 and at end of treatment (approximately 24 months or earlier if patient terminates from the study) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum tolerated dose (MTD) on qd and bid schedules
Number of patients with adverse events, serious adverse events and changes in physical findings, vital signs, clinical laboratory results and ECG findings
Recommended Phase 2 dose of fisogatinib (BLU-554) on qd and bid schedules
Secondary outcome measures
Fibroblast growth factor 19 (FGF19) status in tumor tissue
Levels of FGF19 in blood and tumor samples
Maximum plasma concentration of fisogatinib (BLU-554) on qd and bid schedules
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Fisogatinib (BLU-554)Experimental Treatment1 Intervention
Fisogatinib (BLU-554) capsules for oral administration.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fisogatinib (BLU-554)
2015
Completed Phase 1
~150

Find a Location

Who is running the clinical trial?

Blueprint Medicines CorporationLead Sponsor
29 Previous Clinical Trials
6,063 Total Patients Enrolled

Media Library

Fisogatinib (BLU-554) (Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02508467 — Phase 1
Liver Cancer Research Study Groups: Fisogatinib (BLU-554)
Liver Cancer Clinical Trial 2023: Fisogatinib (BLU-554) Highlights & Side Effects. Trial Name: NCT02508467 — Phase 1
Fisogatinib (BLU-554) (Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02508467 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the estimated population of participants in this experiment?

"As of now, this research project is not enrolling participants. It was first posted in July 2015 and last updated on August 12th 2022. If you're looking for other trials, there are currently 2607 studies related to carcinoma, hepatocellular recruitment as well as 1 trial specifically involving Fisogatinib (BLU-554)."

Answered by AI

Are there other experiments involving Fisogatinib (BLU-554) that have already been conducted?

"At present, Fisogatinib (BLU-554) is being examined in 1 active clinical trial. None of these trials are currently at the Phase 3 stage, but 41 different medical centres across Hong Kong and Jilin are studying its efficacy."

Answered by AI

Has Fisogatinib (BLU-554) attained regulatory acceptance?

"Our team at Power gave Fisogatinib (BLU-554) a rating of 1 due to being in the early stages of clinical trials and having limited data regarding effectiveness and safety."

Answered by AI

Are there a plethora of trial sites operating in this state?

"There are 7 distinct trial sites available, including the Mount Sinai Medical Center in New york City, H. Lee Moffitt Cancer Care Centre situated in Tampa (Florida), and Inland Empire Liver Foundation based out of Rialto (California). The remaining locations can be found below."

Answered by AI

Are there any available vacancies for this medical experiment?

"Sadly, the clinicaltrial.gov platform does not list this study as currently recruiting patients. Originally posted on July 31st 2015 and updated August 12th 2022, it is unavailable to enrollees at present; however, there are 2,608 other studies actively seeking participants."

Answered by AI

Is this a pioneering trial of its kind?

"Currently, one research trial for Fisogatinib (BLU-554) is being carried out in 21 urban areas from 12 nations. Blueprint Medicines Corporation sponsored the original study which began in 2015 and included 150 participants; it went through Phase 1 drug approval before its completion. Since then, no other trials have been concluded."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Phase 1 Study of Fisogatinib (BLU-554) in Patients With Hepatocellular Carcinoma
2015. "A Phase 1 Study of Fisogatinib (BLU-554) in Patients With Hepatocellular Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02508467.
~15 spots leftby May 2025
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