70
Participants
Start Date
July 31, 2006
Primary Completion Date
October 31, 2010
Study Completion Date
October 31, 2010
custirsen (OGX-011)/mitoxantrone
"All subjects began treatment with oral prednisone (5 mg twice daily, 10 mg/day) continued through completion of the final treatment cycle. Three IV administrations of OGX-011 (640 mg) were given as 2 hr infusions during the loading dose period (Days-9 to-1). Subjects were premedicated with either ibuprofen (400 mg) or acetaminophen (650 mg) 30 to 60 minutes prior to and every 4-6 hours for 24 hours following each of the three doses of OGX-011 during the loading dose period only. After the loading dose period, OGX-011 was given weekly on Days 1, 8, and 15 of each 21-day cycle.~Mitoxantrone was administered IV on Day 1 of each cycle at a planned dose of 12 mg/m² infused over 30 minutes.~Patients could receive a maximum of 9 cycles of treatment."
custirsen (OGX-011)/docetaxel
"All subjects began treatment with oral prednisone (5 mg twice daily, 10 mg/day) continued through completion of the final treatment cycle. Three IV administrations of OGX-011 (640 mg) were given as 2 hr infusions during the loading dose period (Days-9 to -1). Subjects were premedicated with either ibuprofen (400 mg) or acetaminophen (650 mg) 30 to 60 minutes prior to and every 4-6 hours for 24 hours following each of the three doses of OGX-011 during the loading dose period only. After the loading dose period, OGX-011 was given weekly on Days 1, 8, and 15 of each 21 day cycle.~Docetaxel was administered IV on Day 1 of each cycle at a planned dose of 75 mg/m² infused over 60 minutes.~Patients could receive a maximum of 9 cycles of treatment."
Tom Baker Cancer Centre, Calgary
Cross Cancer Institute, Edmonton
BC Cancer Agency, Vancouver
CancerCare Manitoba, Winnipeg
QEII Health Sciences, Halifax
Juravinski Cancer Centre, Hamilton
London Regional Cancer Program, London
Toronto Sunnybrook, Toronto
Jewish General Hospital, Montreal
University of Montreal, Montreal
Lead Sponsor
Achieve Life Sciences
INDUSTRY