drugset / Trial / NCT02031731

The Pharmacokinetics and Safety of Onartuzumab (MetMAb) in Chinese Patients With Locally Advanced or Metastatic Solid Tumors

NCT02031731

Phase 1 Completed 30 enrolled Hoffmann-La Roche
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This phase I study will examine the pharmacokinetics and safety of Onartuzumab (MetMAb) in chinese patients with locally advanced or metastatic solid tumors. Patients will be divided into 3 cohorts, which will each be given a different dose of MetMAb. The cohorts will be treated sequentially, starting with the lowest dose. MetMAb will be administered intravenously every 3 weeks. Patients may be treated for up to 16 cycles (21 days each) or 1 year, whichever occurs first, in the absence of disease progression.

Timeline

Start
2014-01-13
Primary completion
2014-04-14
Completion
2014-04-14

Drugs

EvaluationDrugModalityDoseRoute
Subject Onartuzumab Monoclonal antibody 4 mg/kg Intravenous
Subject Onartuzumab Monoclonal antibody 15 mg/kg Intravenous
Subject Onartuzumab Monoclonal antibody 30 mg/kg Intravenous

Indications