A Phase I Study of Henatinib in Patients With Advanced Solid Malignancies

Advanced Solid Cancer Clinical Trial

Official title: A Phase I Study of Henatinib in Patients With Advanced Solid Malignancies

Status Terminated

Clinical Trial Summary

Henatinib is a novel oral multitargeted tyrosine kinase inhibitor with antitumor and antiangiogenic activities. This study is designed to evaluate the safety and tolerability of Henatinib in patients with Advanced Solid Malignancies

Clinical Trial Description

1. To evaluate the safety and tolerability of Henatinib, and the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT).

2. To determine the pharmacokinetic profile of Henatinib and its metabolites .

3. To assess preliminary antitumor activity .

4. To determine preliminary regimen for phase II study . ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Solid Cancer

• NCT number: NCT01416623
• Study type: Interventional
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Status: Terminated
• Phase: Phase 1
• Start date: September 2010
• Completion date: December 2012