Eisai Clinical Trials

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

H3B-6527-G000-101

Study Overview

H3B-6527
H3B-6527
NCT02834780, 2016-001915-19
Dec 2016 - Feb 2022
Hepatocellular Carcinoma (HCC)

1. Part 1, Dose Escalation Phase: Number of Participants With Dose-limiting Toxicities (DLTs) Based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 [Time Frame: Cycle 1 (Cycle length = 21 days)]

2. Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [Time Frame: From the first dose of study drug up to approximately 36.7 months]

  • Males and females 18 Years and older (Adult, Older Adult)

  • Completed

  • Phase 1

  • Belgium, Canada, France, Italy, Korea, Republic of, Russian Federation, Singapore, Spain, Taiwan, United Kingdom, United States See more

Results

CSR Synopsis

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Lay Summary

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Data Sharing

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CSDR Sharing is not available for this study.

CSDR Availability
Clinical Trial Data

Redacted documents may be available upon request for this study.

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Protocol
SAP
Sample CRF
Full CSR