Last updated on September 2018

A Phase 1 Study to Evaluate H3B-8800 in Participants With Myelodysplastic Syndromes Acute Myeloid Leukemia and Chronic Myelomonocytic Leukemia


Brief description of study

This is a Phase 1, open-label, first-in-human (FIH) study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary activity of H3B-8800 in participants with Myelodysplastic Syndromes (MDS), Acute Myeloid Leukemia (AML), or Chronic Myelomonocytic Leukemia (CMML). The study consists of two parts, a dose escalation part (Part 1) and an expansion part (Part 2) exploring a multiple once daily (QD) schedules at the recommended phase 2 dose (RP2D).

Clinical Study Identifier: NCT02841540

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Stanford Cancer Center
Stanford, CA United States
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Massachusetts General Hospital
Boston, MA United States
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Beth Israel Deaconess Medical Center
Boston, MA United States
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Dana Farber Cancer Institute
Boston, MA United States
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Karmanos Cancer Institute
Detroit, MI United States
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Fred Hutchinson Cancer Research Center
Seattle, WA United States
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Mayo Clinic
Rochester, MN United States
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University of Miami
Miami, FL United States
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University of Chicago
Chicago, IL United States
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University of North Carolina Chapel Hill
Chapel Hill, NC United States
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Institut Gustave Roussy
Villejuif, France
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H pital Saint Louis
Paris, France
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Eisai Trial Site 1
Hannover, Germany
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Eisai Trial Site 2
Dresden, Germany
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Clinica Universidad Navarra
Pamplona, Spain
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Hospital General Universitario Gregorio Mara on
Madrid, Spain
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Hospital Universitario Fundacion Jimenez Diaz
Madrid, Spain
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Hospital Universitario HM Sanchinarro - CIOCC
Madrid, Spain
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SCRI - Colorado Blood Cancer Institute
Denver, CO United States
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Mayo Clinic Jacksonville
Jacksonville, FL United States
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H Lee Moffitt Cancer Center and Research Institute
Tampa, FL United States
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Rosewell Park Cancer Center
Buffalo, NY United States
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Memorial Sloan Kettering Cancer Center
New York, NY United States
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Cleveland Clinic
Cleveland, OH United States
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SCRI - Tennessee Oncology
Nashville, TN United States
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MD Anderson Cancer Center
Houston, TX United States
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Recruitment Status: Open


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