Trials / Completed
CompletedNCT01833923
A Phase I Study of Anlotinib on Tolerance and Pharmacokinetics
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 35 (actual)
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
Anlotibib (ALTN) is a kind of innovative medicines approved by State Food and Drug Administration（SFDA） which was researched by Jiangsu Chia-tai Tianqing Pharmaceutical Co., Ltd. ALTN is a kinase inhibitor of receptor tyrosine with multi-targets, especially for VEGFR2 and VEGFR3. It has the obvious resistance to new angiogenesis.
Detailed description
The primary objective of this trial is to explore the maximum tolerated dose(MTD), dose-limiting toxicity(DLT) of ALTN and rational dosage regimen for phase II study, to investigate the pharmacokinetics with single and multiple doses of ALTN from 5mg/d,10mg/d,16mg/d,12mg.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | anlotinib | oral medicine. |
Timeline
- Start date
- 2011-05-01
- Primary completion
- 2015-10-01
- Completion
- 2015-10-01
- First posted
- 2013-04-17
- Last updated
- 2015-10-28
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT01833923. Inclusion in this directory is not an endorsement.