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Fisogatinib

Phase 1

Hepatocellular Carcinoma (HCC) | Small molecule | Oncology |Blueprint Medicines Corporation|Last Updated: Apr 12, 2024

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment146

FDA Designations

No designations recorded

Clinical trial landscape

Fisogatinib · 1 trial · 1 indication

Phase 1 1
NCT02508467A Phase 1 Study of Fisogatinib (BLU-554) in Patients With Hepatocellular CarcinomaHepatocellular Carcinoma (HCC)
COMPLETED146 Analytics
PHASE1COMPLETED
A Phase 1 Study of Fisogatinib (BLU-554) in Patients With Hepatocellular Carcinoma
Hepatocellular Carcinoma (HCC)
NCT02508467146
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Study Endpoints

Primary Endpoints

Maximum tolerated dose (MTD) on qd and bid schedules
During cycle 1 (28 days) of treatment and will be determined by approximately 24 months after start of the study or earlier
Recommended Phase 2 dose of fisogatinib (BLU-554) on qd and bid schedules
At the end of every cycle (28 days) of treatment and will be determined by approximately 24 months after start of the study or earlier
Number of patients with adverse events, serious adverse events and changes in physical findings, vital signs, clinical laboratory results and ECG findings
Every cycle (28 days) for approximately 24 months or earlier if patient terminates from the study

Secondary Endpoints

Maximum plasma concentration of fisogatinib (BLU-554) on qd and bid schedules
Every cycle (28 days) up to cycle 4 and at end of treatment (approximately 24 months or earlier if patient terminates from the study)
Time to maximum plasma concentration of fisogatinib (BLU-554) on qd and bid schedules
Every cycle (28 days) up to cycle 4 and at end of treatment (approximately 24 months or earlier if patient terminates from the study)
Fibroblast growth factor 19 (FGF19) status in tumor tissue
Cycle 2 (Day 56)
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Fisogatinib (BLU-554)EXPERIMENTALFisogatinib (BLU-554) capsules for oral administration.

Interventions

NameTypeDescription
Fisogatinib (BLU-554)DRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites41

Key Inclusion Criteria: * Confirmed diagnosis of HCC by histological examination or by non-invasive criteria according to European Association for the Study of the Liver (EASL) or American Association for the Study of Liver Disease (AASLD) guidelines (Part 1, 2 and 3). * For Part 1 and 2, the patie...

Countries:United StatesChinaFranceGermanyHong KongItalySingaporeSouth KoreaSpainSwitzerlandTaiwanUnited Kingdom
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Frequently asked questions about Fisogatinib

What is Fisogatinib used for in Hepatocellular Carcinoma?

Fisogatinib is an investigational small molecule being studied for the treatment of Hepatocellular Carcinoma (HCC), a type of liver cancer. It is developed by Blueprint Medicines Corporation and is currently in clinical development, having completed a Phase 1 trial.

What does Fisogatinib target?

Fisogatinib is a small molecule designed to target specific molecular pathways involved in cancer. However, the specific molecular target has not been disclosed in available information. It is being investigated for its potential role in treating Hepatocellular Carcinoma.

Who makes Fisogatinib?

Fisogatinib is developed by Blueprint Medicines Corporation, a biopharmaceutical company traded on the NASDAQ under the ticker symbol BPMC. The company is conducting clinical research to evaluate the drug's safety and efficacy in patients with Hepatocellular Carcinoma.

What phase is Fisogatinib in?

Fisogatinib is in Phase 1 of clinical development. A Phase 1 study has been completed, which focused on evaluating the drug's safety, tolerability, and pharmacokinetics in patients with Hepatocellular Carcinoma. It is not yet approved by regulatory authorities.

What clinical trials is Fisogatinib in?

Fisogatinib has been studied in a completed Phase 1 clinical trial with the identifier NCT02508467. This trial enrolled 146 participants with Hepatocellular Carcinoma across multiple countries, including the United States, China, France, Germany, and others. The study was not randomized or double-blinded.

Is Fisogatinib the same as BLU-554?

Yes, Fisogatinib is also known as BLU-554. The Phase 1 clinical trial NCT02508467 is titled 'A Phase 1 Study of Fisogatinib (BLU-554) in Patients With Hepatocellular Carcinoma,' confirming that both names refer to the same investigational drug.