A Phase 1 Study of Fisogatinib (BLU-554) in Patients With Hepatocellular Carcinoma
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ClinicalTrials.gov Identifier: NCT02508467 |
Recruitment Status :
Active, not recruiting
First Posted : July 27, 2015
Last Update Posted : August 15, 2022
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Sponsor:
Blueprint Medicines Corporation
Information provided by (Responsible Party):
Blueprint Medicines Corporation
Tracking Information | |||
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First Submitted Date ICMJE | July 9, 2015 | ||
First Posted Date ICMJE | July 27, 2015 | ||
Last Update Posted Date | August 15, 2022 | ||
Actual Study Start Date ICMJE | July 31, 2015 | ||
Actual Primary Completion Date | June 30, 2021 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||
Original Other Pre-specified Outcome Measures | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | A Phase 1 Study of Fisogatinib (BLU-554) in Patients With Hepatocellular Carcinoma | ||
Official Title ICMJE | A Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of BLU-554 in Patients With Hepatocellular Carcinoma | ||
Brief 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. | ||
Detailed Description | Not Provided | ||
Study Type ICMJE | Interventional | ||
Study Phase ICMJE | Phase 1 | ||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Hepatocellular Carcinoma (HCC) | ||
Intervention ICMJE | Drug: Fisogatinib (BLU-554)
Other Name: BLU-554
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Study Arms ICMJE | Experimental: Fisogatinib (BLU-554)
Fisogatinib (BLU-554) capsules for oral administration.
Intervention: Drug: Fisogatinib (BLU-554)
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Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Active, not recruiting | ||
Estimated Enrollment ICMJE |
150 | ||
Original Estimated Enrollment ICMJE |
60 | ||
Estimated Study Completion Date ICMJE | December 31, 2022 | ||
Actual Primary Completion Date | June 30, 2021 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Key Inclusion Criteria:
Key Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||
Accepts Healthy Volunteers ICMJE | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | China, France, Germany, Hong Kong, Italy, Korea, Republic of, Singapore, Spain, Switzerland, Taiwan, United Kingdom, United States | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT02508467 | ||
Other Study ID Numbers ICMJE | BLU-554-1101 2015-001662-26 ( EudraCT Number ) |
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Has Data Monitoring Committee | No | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement ICMJE | Not Provided | ||
Current Responsible Party | Blueprint Medicines Corporation | ||
Original Responsible Party | Same as current | ||
Current Study Sponsor ICMJE | Blueprint Medicines Corporation | ||
Original Study Sponsor ICMJE | Same as current | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Blueprint Medicines Corporation | ||
Verification Date | August 2022 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |