Trials / Unknown
UnknownNCT02671513
A Tolerability and Pharmacokinetics Study of SHR6390 in Advanced Melanoma Patients
A Tolerability and Pharmacokinetics Phase 1 Study of SHR6390 in Advanced Melanoma Patients
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SHR6390 | SHR6390 either 50mg,75mg,100mg,125mg,150mg,175mg given orally, QD |
Timeline
- Start date
- 2016-01-01
- Primary completion
- 2016-11-01
- Completion
- 2017-04-01
- First posted
- 2016-02-02
- Last updated
- 2016-04-12
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT02671513. Inclusion in this directory is not an endorsement.