drugset / Trial / NCT01455571
Phase I Study to Determine the Maximum Tolerated Dose and to Assess the Safety and Pharmacokinetic Profile of HM781-36B in Patients With Advanced Solid Tumors
Phase 1
Completed
55 enrolled
Hanmi Pharmaceutical Company Limited
Seoul National University · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The main objective of this study is to determine the maximum tolerated dose (MTD) of HM781-36B.
Timeline
- Start
- 2009-11
- Primary completion
- 2013-01
- Completion
- 2013-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Poziotinib | Small molecule | 0.5 mg | Oral |
| Subject | Poziotinib | Small molecule | 1 mg | Oral |
| Subject | Poziotinib | Small molecule | 2 mg | Oral |
| Subject | Poziotinib | Small molecule | 4 mg | Oral |
| Subject | Poziotinib | Small molecule | 8 mg | Oral |
| Subject | Poziotinib | Small molecule | 12 mg | Oral |
| Subject | Poziotinib | Small molecule | 16 mg | Oral |
| Subject | Poziotinib | Small molecule | 20 mg | Oral |