Trials / Terminated
TerminatedNCT01416623
A Phase I Study of Henatinib in Patients With Advanced Solid Malignancies
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 44 (actual)
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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
Detailed 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 .
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | henatinib | Henatinib Maleate Tablets |
Timeline
- Start date
- 2010-09-01
- Primary completion
- 2012-12-01
- Completion
- 2012-12-01
- First posted
- 2011-08-15
- Last updated
- 2012-12-21
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT01416623. Inclusion in this directory is not an endorsement.