57
Participants
Start Date
August 31, 2010
Primary Completion Date
December 31, 2016
Study Completion Date
December 31, 2016
Demcizumab
Up to 50 subjects will be enrolled at up to 8 centers in Australia, New Zealand, and Spain. Up to 28 days (4 weeks) prior to treatment you will undergo testing to determine your eligibility to take part in this study, and then if you are enrolled in the study you will receive intravenous (in the vein) infusions of the demcizumab administered once every 2 weeks, and gemcitabine and Abraxane® administered weekly for 3 weeks, out of every 4 weeks. After 9 weeks, you will undergo assessments to determine the status of your disease. If there is no evidence of progression of your disease or if your tumor is smaller, you will continue to receive one additional infusion of demcizumab, and you will continue to receive infusions of gemcitabine and Abraxane® once weekly for 3 consecutive weeks out of every 4 weeks until it has been shown that your cancer has progressed. You will undergo assessments every 8 weeks thereafter to determine the status of your disease.
Abraxane®
Abraxane® which will be administered by IV infusion at a dose of 125 mg/m2 over 30 minutes once a week for 3 weeks in a row, followed by a week of rest.
Gemcitabine
Gemcitabine will be administered intravenously over 30 minutes initially at a dose of 1000 mg/m2 once a week for 3 weeks in a row, followed by a week of rest. If you develop side effects during this time period, your physician may decide to hold or reduce the dose of gemcitabine.
Royal Prince Alfred Hospital, Camperdown
Box Hill Hospital, Box Hill
The Austin Hospital, Heidelberg
Christchurch Hospital, Christchurch
Waikato Hospital, Hamilton
START Madrid, Madrid
Lead Sponsor
Novotech (Australia) Pty Limited
INDUSTRY
OncoMed Pharmaceuticals, Inc.
INDUSTRY