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
3800 Reservoir Road Northwest
Washington, District of Columbia 20007
Washington, District of Columbia 20007
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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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Philadelphia, Pennsylvania 19104
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