Trials / Unknown
UnknownNCT01772732
Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of Simotinib Hydrochloride in Patients With Advanced NSCLC
Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of Simotinib Hydrochloride in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective is to assess the safety and tolerability of multiple doses of Simotinib Hydrochloride in NSCLC patients. The secondary objective is to determine the pharmacokinetic (PK) profile and explore the preliminary anti-tumor activity.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Simotinib Hydrochloride |
Timeline
- Start date
- 2012-12-01
- Primary completion
- 2015-12-01
- Completion
- 2015-12-01
- First posted
- 2013-01-21
- Last updated
- 2015-04-09
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT01772732. Inclusion in this directory is not an endorsement.