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Fisogatinib

Phase 1

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

Fisogatinib target and mechanism

Target class-Tinib (Kinase)
ModalitySmall molecule

Also known as Fisogatinib (BLU-554)

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment146

FDA Designations

No designations recorded

Fisogatinib clinical trials

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)Unlock trial analytics

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?

Fisogatinib is an investigational small molecule being studied for the treatment of hepatocellular carcinoma (HCC), the most common form of primary liver cancer. It is being developed as an oral therapy for patients with this condition and has been evaluated in a Phase 1 clinical study.

What does fisogatinib target?

Fisogatinib is a kinase inhibitor, belonging to the -tinib class of small molecule drugs. Kinase inhibitors work by blocking specific enzymes that drive cancer cell growth and survival. Fisogatinib is designed to inhibit its kinase target in the context of hepatocellular carcinoma.

Who is developing fisogatinib?

Fisogatinib is being developed by Blueprint Medicines Corporation, a biopharmaceutical company that trades under the ticker symbol BPMC. Blueprint Medicines focuses on precision therapies for cancer and other diseases, and fisogatinib is part of its oncology pipeline.

What phase is fisogatinib in?

Fisogatinib is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA for any indication. The Phase 1 study evaluating fisogatinib in hepatocellular carcinoma has been completed.

What clinical trials is fisogatinib in?

Fisogatinib has been evaluated in a Phase 1 study, NCT02508467, titled A Phase 1 Study of Fisogatinib (BLU-554) in Patients With Hepatocellular Carcinoma. The trial enrolled 146 patients across the United States, China, France, Germany, Hong Kong, Italy, Singapore, South Korea, Spain, Switzerland, Taiwan, and the United Kingdom, and it is now completed.

Is fisogatinib the same as BLU-554?

Yes, fisogatinib is also known as BLU-554. Both names refer to the same investigational small molecule developed by Blueprint Medicines Corporation for hepatocellular carcinoma. The Phase 1 trial NCT02508467 lists the drug under the name fisogatinib (BLU-554).