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 |
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.
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
Philadelphia, Pennsylvania 19104
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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
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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University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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92 2nd St
Hackensack, New Jersey 07601
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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3800 Reservoir Road Northwest
Washington, District of Columbia 20007
Washington, District of Columbia 20007
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