drugset
drugset / Trial / NCT01773018

Phase I Study of the Volitinib (HMPL-504) in Patients With Advanced Solid Tumors

NCT01773018 ↗

Phase 1 Completed 47 enrolled Hutchison Medipharma Limited Austin Hospital, Melbourne Australia · collabMonash University · collabSir Charles Gairdner Hospital · collab
NaSingle-groupOpen-labelTreatment

Summary

Volitinib (HMPL-504) is a novel, highly potent and selective small molecule inhibitor of c-Met kinase. In preclinical studies, it demonstrated strong in vitro and in vivo activity against c-Met kinase and its downstream signaling targets and inhibited tumor cell growth. 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-504 at single doses and multiple doses.

Timeline

Start
2012-02
Primary completion
2015-12
Completion
2016-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Savolitinib Small molecule 100 mg Oral
Subject Savolitinib Small molecule 200 mg Oral
Subject Savolitinib Small molecule 400 mg Oral
Subject Savolitinib Small molecule 600 mg Oral
Subject Savolitinib Small molecule 800 mg Oral
Subject Savolitinib Small molecule 1000 mg Oral

Indications

neoplasm