Phase 1 Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of H3B-6527 in Participants With Advanced Hepatocellular Carcinoma



Status:Recruiting
Conditions:Liver Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/4/2019
Start Date:July 2016
End Date:June 2020
Contact:Eisai Medical Information
Email:esi_oncmedinfo@eisai.com
Phone:1-888-274-2378

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An Open-Label Multicenter Phase 1 Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of H3B-6527 in Subjects With Advanced Hepatocellular Carcinoma or Intrahepatic Cholangiocarcinoma

The purpose of this study is to determine the maximum tolerated dose (MTD) and recommended
Phase 2 dose (RP2D) of H3B-6527, and to assess the safety, tolerability and pharmacokinetics
of H3B-6527.


Inclusion criteria:

1. Participants with hepatocellular carcinoma (HCC) or intrahepatic cholangiocarcinoma
(ICC).

2. Must have received at least one prior standard-of-care therapy or declined such
therapy.

3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.

4. Must be willing to undergo a biopsy prior to treatment and on Cycle 2 Day 1 (Part 2
only).

5. Adequate bone marrow and organ function.

Exclusion criteria:

1. Uncontrolled significant active infections, except Hepatitis B (HBV) or Hepatitis C
(HCV).

2. Known human immunodeficiency virus (HIV) infection.

3. Presence of gastric or esophageal varices requiring active treatment.

4. Previous treatment with 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.
We found this trial at
16
sites
92 2nd St
Hackensack, New Jersey 07601
(201) 996-5900
John Theurer Cancer Center at the Hackensack University Medical Center The mission of the John...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Boston, MA
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4100 John R
Detroit, Michigan 48201
800-527-6266
Barbara Ann Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Chicago, Illinois 60611
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Cincinnati, OH
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1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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Durham, North Carolina 27710
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Edmonton, Alberta
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Gainesville, Florida 32610
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Orange, California 92868
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Philadelphia, PA
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Richmond, Virginia 23249
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Santa Monica, California 90404
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3800 Reservoir Road Northwest
Washington, District of Columbia 20007
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