Study of a c-Met Inhibitor PLB1001 in Patients With PTPRZ1-MET Fusion Gene Positive Recurrent High-grade Gliomas
NCT02978261 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2020-03-04
Summary
This phase I, open-label, dose-escalation study was conducted to determine the maximum tolerated dose (MTD), recommended phase II dose (RP2D), dose-limiting toxicities (DLTs), pharmacokinetics (PK) profile, and preliminary antitumor activity of single and multiple doses of PLB1001 in Patients with PTPRZ1-MET fusion gene positive recurrent high-grade Gliomas.
Conditions
Interventions
- DRUG
-
PLB1001
PLB1001 is a capsule in the form of 25 mg and 100mg, twice daily.
Sponsors & Collaborators
-
Beijing Pearl Biotechnology Limited Liability Company
lead INDUSTRY
Principal Investigators
-
Wenbin Li, MD · Beijing Shijitan Hospital, CMU
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-09-30
- Primary Completion
- 2018-04-30
- Completion
- 2018-12-31
Countries
- China
Study Locations
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