NCT01645215

Phase I Study of Fruquintinib(HMPL-013) in Patients With Advanced Solid Tumors

Phase I Study of Safety and Pharmacokinetics of Fruquintinib(HMPL-013) in Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Hutchison Medipharma Limited · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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 .

Detailed description

This will be an open-label, phase I study. This study will evaluate the safety and pharmacokinetics of HMPL-013 after a single administration followed by a 28-Day continuous course of therapy; evaluate the safety and preliminary efficacy in an open-label administration of at the MTD. All subjects of this study will be permitted to continue therapy with only safety monitoring and bimonthly assessments for progression, if the product is well tolerated and the subject has stable disease or better.

Conditions

• Tumor

Interventions

Type	Name	Description
DRUG	Fruquintinib	Fruquintinib is a capsule in the form of 0.25mg , 1mg and 5mg, oral, once a day.

Timeline

• Start date: 2011-01-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2012-07-20
• Last updated: 2020-02-17

Locations

1 site across 1 country: China