50
Participants
Start Date
September 30, 2010
Primary Completion Date
September 30, 2016
Study Completion Date
September 30, 2016
Demcizumab
The 6 subjects in the first cohort will receive demcizumab 5 mg/kg once every 3 weeks; the 6 subjects in the subsequent cohort will be treated with 10 mg/kg once every 3 weeks; and the 6 subjects in the final cohort will be treated with 15 mg/kg once every 3 weeks. A Data Safety Monitoring Board (DSMB) will review the data for the 6 subjects in each dose cohort after the last subject in that cohort has been on study for 56 days and then decide whether it is safe to escalate to the next highest dose cohort. Once the dose-escalation portion of the study has been completed, 14 additional subjects will be treated at the highest dose level that the DSMB deems as safe.
Monash Medical Centre, Clayton
Royal Brisbane & Women's Hospital, Herston
Ashford Cancer Centre Research, Kurralta Park
Sir Charles Gairdner Hospital, Nedlands
Auckland Hospital, Grafton
Waikato Hospital, Hamilton
START Madrid, Madrid
Lead Sponsor
Novotech (Australia) Pty Limited
INDUSTRY
OncoMed Pharmaceuticals, Inc.
INDUSTRY