Phase 1 Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of H3B-6527 in Participants With Advanced Hepatocellular Carcinoma
NCT ID: NCT02834780
Last Updated: 2023-11-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
128 participants
INTERVENTIONAL
2016-12-28
2022-02-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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H3B-6527 (escalation and expansion)
Hepatocellular Carcinoma
H3B-6527
H3B-6527 by mouth once or twice daily at specified doses.
Interventions
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H3B-6527
H3B-6527 by mouth once or twice daily at specified doses.
Eligibility Criteria
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Inclusion Criteria
2. Must have had at least one prior standard-of-care therapy, unless contraindicated.
3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
4. Must be willing to undergo a biopsy up to 8 weeks before administration of H3B-6527 on Cycle 1 Day 1 for part 2 (dose expansion).
5. Adequate bone marrow and organ function.
Exclusion Criteria
2. Known human immunodeficiency virus infection.
3. Presence of gastric or esophageal varices requiring active treatment.
4. Previous treatment with a selective FGF19-FGFR4 targeted therapy.
5. Females of childbearing potential, or males who have not had a successful vasectomy, who are unable or unwilling to follow adequate contraceptive measures.
6. Hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption.
18 Years
ALL
No
Sponsors
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Eisai Inc.
INDUSTRY
H3 Biomedicine Inc.
INDUSTRY
Responsible Party
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Locations
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USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States
UC Irvine Medical Center
Orange, California, United States
UCLA Medical Center
Santa Monica, California, United States
Georgetown Unversity Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, United States
Northwestern Unversity
Chicago, Illinois, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
John theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States
Duke University Cancer Center
Durham, North Carolina, United States
University of Cincinnati Cancer Institute
Cincinnati, Ohio, United States
University of Pennsylsvania - Perelman Cancer Center for Advanced Medicine
Philadelphia, Pennsylvania, United States
Simmons Comprehensive Cancer Center
Dallas, Texas, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
McGuire VA Medical Center
Richmond, Virginia, United States
UCL Cliniques universitaires Saint-Luc
Woluwe-Saint-Lambert, Brussels Capital, Belgium
Universitair Ziekenhuis Gent
Ghent, , Belgium
Cross Cancer Institute
Edmonton, Alberta, Canada
Jurvanski Cancer Center
Hamilton, Ontario, Canada
Institut Bergonié
Bordeaux, , France
Centre Oscar Lambret
Lille, , France
Hôpital Haut-Lévêque - CHU de Bordeaux
Pessac, , France
Centre Eugène Marquis
Rennes, , France
IRCCS Istituto Scientifico Romagnolo per lo studio e la cura dei tumori - U.O. di Oncologia Medica
Meldola, , Italy
IRCCS Ospedale San Raffaele S.r.l. - PPDS
Milan, , Italy
Azienda Ospedaliero Universitaria - Policlinico di Modena
Modena, , Italy
Altay Regional Oncology Center
Barnaul, Altay, Re, Russia
Russian Oncology Research Center n a N N Blokhin
Moscow, , Russia
Omsk Regional Oncology Center
Omsk, , Russia
Railway Clinical Hospital JSC RZhD
Saint Petersburg, , Russia
City Clinical Oncology Dispensary
Saint Petersburg, , Russia
National University Cancer Insitute
Singapore, , Singapore
Asan Medical Center
Seoul, , South Korea
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, Spain
Clínica Universidad de Navarra
Pamplona, Navarre, Spain
Hospital Universitario de Badajoz
Badajoz, , Spain
Hospital Universitario Vall d'Hebron
Barcelona, , Spain
General Universitario Gregorio Maranon
Madrid, , Spain
START Madrid FJD, Hospital Universitario Fundacion Jimenez Diaz
Madrid, , Spain
Hospital Universitario HM Sanchinarro
Madrid, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Taichung Veterans General Hospital
Taichung, , Taiwan
National Cheng Kung University Hospital
Tainan City, , Taiwan
Sarah Cannon Research Institute UK - SCRI - PPDS
London, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2016-001915-19
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
H3B-6527-G000-101
Identifier Type: -
Identifier Source: org_study_id
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