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

NCT01773018 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2016-06-01

No results posted yet for this study

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.

Conditions

  • Tumor

Interventions

DRUG

Volitinib

Volitinib(HMPL-504) is a tablet in the form of 25 mg ,100mgand 200 mg,oral,once daily.

Sponsors & Collaborators

  • Sir Charles Gairdner Hospital

    collaborator OTHER

  • Austin Hospital, Melbourne Australia

    collaborator OTHER

  • Monash University

    collaborator OTHER

  • Hutchison Medipharma Limited

    lead INDUSTRY

Principal Investigators

  • Michael Millward, MD,Ph.D · Sir Charles Gairdner Hospital & University of WA

  • Hui Gan, MD,Ph.D · Austin Hospital, Melbourne Australia

  • Jason Lickliter, MD,Ph.D · Southern Health and Monash Institute of Medical Research

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2015-12-31
Completion
2016-05-31

Countries

  • Australia

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01773018 on ClinicalTrials.gov