18
Participants
Start Date
September 30, 2010
Primary Completion Date
February 28, 2011
Study Completion Date
February 28, 2011
OMP-21M18
The first 6 participants will receive OMP21M18 2.5 mg/kg once every other week, the next 6 participants will receive 5 mg/kg once every other week, and the final 6 participants will receive 10 mg/kg once every other week. A Data Safety Monitoring Board (DSMB) will review the data for the 6 participants in each dose level after the last participant in that group has been treated for 56 days and decide whether it is safe to move up to the next highest dose level. After confirming the optimum dose, 14 additional participants will be treated at the highest dose level that the DSMB considers safe.
Sydney Cancer Centre, Camperdown
Waikato Hospital, Hamilton
Royal Brisbane & Women's Hospital, Herston
Ashford Cancer Centre Research, Kurralta Park
Sir Charles Gairdner Hospital, Nedlands
Lead Sponsor
Novotech (Australia) Pty Limited
INDUSTRY
OncoMed Pharmaceuticals, Inc.
INDUSTRY