A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study Evaluating the Pain Palliation Benefit of Adding Custirsen to a Taxane for Second-Line Chemotherapy in Men With Castrate Resistance Prostate Cancer
This is a randomized, double-blind, placebo-controlled, multicenter, international trial
enrolling patients with metastatic CRPC who had a response to first-line docetaxel therapy
and have prostate cancer-related pain with progression of disease. The intended intervention
is second-line treatment with docetaxel retreatment or cabazitaxel plus study agent, where
custirsen is to be administered in the investigational arm and placebo is to be administered
in the control arm.
Selection of the chemotherapy (docetaxel re-treatment or cabazitaxel) is to be determined by
the treating physician, based on the patient's first-line response.
The study will primarily assess pain and analgesic use for evaluation of durable pain
palliation in response to study treatment. Pain and analgesic use will be obtained via a
3rd party contact center (direct contact with patient).
Study treatment starts with a Loading Dose Period during which three infusions of study
agent (custirsen vs. placebo) will be administered. Following the Loading Dose Period, study
treatment will consist of docetaxel or cabazitaxel on a 21-day cycle with weekly study agent
(custirsen vs. placebo) infusions on Day 1, 8 and 15 of each 21-day cycle and oral
Patients will continue study treatment until pain progression, unacceptable toxicity,
completion of 10 cycles or other specific criteria for withdrawal identified in the
protocol. If study treatment is completed or discontinued prior to pain progression, 6-day
assessments will continue every 3 weeks until pain progression is documented. Follow-up
after study treatment will occur for safety parameters for 3 weeks after the last study
agent infusion in all patients. Survival status updates are to be reported every 12 weeks
following documentation of pain progression. The amount of time that patients remain on the
study will vary; but the average survival of these patients who receive second line taxane
treatment is expected to be 14 to 15 months.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
To ascertain whether the investigational arm has a greater proportion of patients with durable pain palliation as compared to the control arm.
3 to 6 months
Tomasz M Beer, M.D.
Oregon Health and Science University
United States: Food and Drug Administration
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