Phase I Study of Fruquintinib(HMPL-013) in Patients With Advanced Solid Tumors
Completed
Fudan University
Phase 1
2011-01-01
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 .
Phase I Study of Fruquintinib(HMPL-013) in Patients With Advanced Solid Tumors
Completed
Hutchison Medipharma Limited
Phase 1
2011-01-01
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 .
Fruquintinib is a novel oral small molecule compound discovered and developed by Hutchison
MediPharma that selectively inhibits vascular endothelial growth factor receptors (VEGFR) 1,
2, and 3 and has demonstrated potent inhibitory effects on multiple human tumor
xenografts.Based on first-in-human study, both 4mg QD and 5mg 3wks on/1wk off are safety and
efficacy, this phase Ib study is to evaluable the safety, tolerability and efficacy of these
2 regimens with mCRC failed 2nd therapy or more and to determine the recommended dose and
regimen in phase II/III study.
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