drugset / Trial / NCT02671513
A Tolerability and Pharmacokinetics Study of SHR6390 in Advanced Melanoma Patients
Phase 1
Unknown
30 enrolled
Jiangsu HengRui Medicine Co., Ltd.
Peking University Cancer Hospital & Institute · collab
NaSingle-groupOpen-labelTreatment
Summary
SHR6390 is a small molecular,oral potent, selective CDK4/6 inhibitor. The purpose of this study is to investigate the safety/tolerability and the pharmacokinetic profile of SHR6390 in Chinese advanced melanoma patients by using a "3+3" dose escalation.Preliminary efficacy will be also investigated in this study.
Timeline
- Start
- 2016-01
- Primary completion
- 2016-11
- Completion
- 2017-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dalpiciclib | Small molecule | 50 mg | Oral |
| Subject | Dalpiciclib | Small molecule | 75 mg | Oral |
| Subject | Dalpiciclib | Small molecule | 100 mg | Oral |
| Subject | Dalpiciclib | Small molecule | 125 mg | Oral |
| Subject | Dalpiciclib | Small molecule | 150 mg | Oral |
| Subject | Dalpiciclib | Small molecule | 175 mg | Oral |