This Phase 3 study has been designed to confirm that adding custirsen to standard first-line docetaxel/prednisone treatment can slow tumor progression and enhance survival outcomes compared to standard first-line docetaxel/prednisone treatment alone. This will be a randomized, open-label, multicenter, international trial. Treatment will consist of docetaxel/prednisone/custirsen vs. docetaxel/prednisone. A total of at least 1000 patients will be randomized. Patients will be randomly assigned with equal probability to the two arms.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,022
Dexamethasone 8 mg by mouth twice a day for 3 days beginning one day before docetaxel administration to reduce the incidence and severity of hypersensitivity reactions and fluid retention.
Kaplan-Meier Estimates for Time to Death (Overall Survival)
Time from the date of randomization to death from any cause. After stopping treatment, patients were followed every 4 weeks until disease progression and then followed every 12 weeks until death.
Time frame: Randomization (approximately Day -12) to longest survival follow-up (Day 971).
Percentage of Participants Who Were Alive Without Event At Day 140
Patients who were alive without event (AWE) are patients who had their Milestone Day 140 Disease Status performed per protocol (Day 125 - Day 155 window), were not determined to have disease progression by the investigator on that window and confirmed as not having progressive disease (NONPD) by the Central Imagine Lab independent review.
Time frame: Day 125-155
Percentage of Participants with Adverse Events
An adverse event (AE) is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the administration, at any dose, of a medicinal or therapeutic product whether or not considered related to that product. Severity was rated by the investigator on a scale of 1 (mild) to 5 (death). A severity of 3 = Severe or medically significant but not immediately life-threatening. A severity of 4 = Life-threatening. Serious AEs include death (death due to progressive disease were not reported as an SAE), a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.
Time frame: Docetaxel/prednisone/custirsen arm: Days -9 up to Day 743. Docetaxel/prednisone arm: Day 1 up to Day 400.
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Teva Investigational Site 100
Birmingham, Alabama, United States
Teva Investigational Site 086
Los Angeles, California, United States
Teva Investigational Site 263
Los Angeles, California, United States
Teva Investigational Site 093
Marina del Rey, California, United States
Teva Investigational Site 097
San Diego, California, United States
Teva Investigational Site 090
Fort Collins, Colorado, United States
Teva Investigational Site 106
Fort Myers, Florida, United States
Teva Investigational Site 094
Port Saint Lucie, Florida, United States
Teva Investigational Site 096
Atlanta, Georgia, United States
Teva Investigational Site 103
Baton Rough, Louisiana, United States
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