Title: A Pilot Study Evaluating the Safety and Feasibility of Custirsen (OGX-011) in Combination With Second Line Chemotherapy in Patients With Hormone Refractory Prostate Cancer
This study was initiated as a multicenter, open-label, randomized study, with a planned
enrollment of 40 subjects. Although two treatment arms were included in this study, no
comparison between the arms was intended.
Subjects with metastatic HRPC who failed first-line docetaxel therapy and required
second-line therapy were randomly assigned to treatment with OGX-011 in combination with
docetaxel/prednisone (OGX-011/docetaxel/prednisone) or OGX-011 in combination with
mitoxantrone/prednisone (OGX-011/mitoxantrone/ prednisone). The study was randomized to
assure that subjects were enrolled in each of the two treatment arms in an unbiased manner.
Based on preliminary safety data from the first 44 subjects who were randomized to receive
either docetaxel or mitoxantrone, the protocol was amended to enroll approximately 20
additional subjects who would be assigned to the docetaxel/prednisone treatment arm to
further investigate safety of the combination.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety and Tolerability of Custirsen (OGX-011) in Combination With Either Docetaxel/Prednisone or Mitoxantrone/Prednisone as Second-line Chemotherapy.
Safety and tolerability were based on Adverse Events (AE) and Serious Adverse Events (SAE) graded using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE). The CTCAE has 5 grades with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1=Mild AE; Grade 2=Moderate AE; Grade 3=Severe AE; Grade 4=Life-threatening or disabling AE; and Grade 5=Death related to AE.
Subjects were followed for safety from enrollment for up to 8 months (9 three-week cycles plus 30 days after end of treatment)
Fred Saad, MD, FRCS
Université de Montréal
United States: Food and Drug Administration