drugset / Trial / NCT02467569
Study Evaluating Hemay020 In Subjects With Advanced Solid Cancer
Phase 1
Terminated
10 enrolled
Tianjin Hemay Pharmaceutical Co., Ltd
Hainan General Sanyang Pharmaceutical Co., Ltd · collab
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to assess the pharmacokinetics,safety and tolerability of Hemay020 and to determine the recommended dose for future Phase II study as well as to obtain preliminary information on the efficacy of Hemay020 in subjects with solid tumors. The study will be conducted in two parts. Part one, testing will be done on up to 16-31 subjects to determine the safety and tolerability of Hemay 020 in patients with advanced solid tumors. Part two, another 16-24 subjects with advanced or metastatic NSCLC, will be added to the trial to better define the tolerability and preliminary efficacy of Hemay020.
Timeline
- Start
- 2015-07-03
- Primary completion
- 2017-12-31
- Completion
- 2017-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Hemay020 | Unknown | 25 mg | Oral |
| Subject | Hemay020 | Unknown | 50 mg | Oral |
| Subject | Hemay020 | Unknown | 100 mg | Oral |
| Subject | Hemay020 | Unknown | 200 mg | Oral |
| Subject | Hemay020 | Unknown | 300 mg | Oral |