Evaluation of Safety and Feasibility of OGX-011 in Combination With 2nd-line Chemotherapy in Patients With HRPC

PHASE2CompletedINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

July 31, 2006

Primary Completion Date

October 31, 2010

Study Completion Date

October 31, 2010

Conditions
Prostate Cancer
Interventions
DRUG

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."

DRUG

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."

Trial Locations (10)

Unknown

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

Sponsors
All Listed Sponsors
lead

Achieve Life Sciences

INDUSTRY