Phase I Study of Fruquintinib(HMPL-013) in Patients With Advanced Solid Tumors
NCT01645215 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2020-02-17
Summary
Fruquintinib (HMPL-013) is a novel oral small molecule that selectively inhibits vascular endothelial growth factor receptors (VEGFR) 1, 2, and 3 and has demonstrated potent inhibitory effects on multiple human tumor xenografts. This first-in-human study is conducted to assess the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT), to evaluate the pharmacokinetics , safety and preliminary anti-tumor activity of HMPL-013 at single doses and multiple doses .
Conditions
- Tumor
Interventions
- DRUG
-
Fruquintinib is a capsule in the form of 0.25mg , 1mg and 5mg, oral, once a day.
Sponsors & Collaborators
-
Fudan University
collaborator OTHER -
Hutchison Medipharma Limited
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-01-31
- Primary Completion
- 2012-10-31
- Completion
- 2012-10-31
Countries
- China
Study Locations
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