A Study of SHR6390 in Advanced Solid Tumor Patients
NCT02684266 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2022-07-11
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 solid tumor patients by using a "3+3" dose escalation.Preliminary efficacy will be also investigated in this study.
Conditions
Interventions
- DRUG
-
SHR6390
SHR6390 either 25, 50mg, 75mg, 100mg, 125mg, 150mg, 175mg given orally, QD
Sponsors & Collaborators
-
Jiangsu HengRui Medicine Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Binhe Xu, M.D · Cancer Hosptial, Chinese Academy of Medical Sciences
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-03-03
- Primary Completion
- 2019-06-28
- Completion
- 2019-06-28
Countries
- China
Study Locations
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