This is a randomized, double-blind, placebo-controlled, multinational Phase 2 study to evaluate and compare oral AT-101 in combination with docetaxel and prednisone versus docetaxel and prednisone plus placebo in the treatment of chemotherapy-naïve metastatic hormone-refractory prostate cancer, who have received hormonal therapy but not chemotherapy.
Further Study Details provided by Ascenta.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
220
docetaxel (75mg/m2 intravenously over 1 hour on day 1, every 21 days \[one cycle\]), oral prednisone (5mg BID on days 1-21), and oral AT-101 on cycle days 1-3
docetaxel (75mg/m2 intravenously over 1 hour every 21 days \[one cycle\]), oral prednisone (5mg BID on days 1-21), and oral placebo on cycle days 1-3
Unnamed facility
Colorado Springs, Colorado, United States
To evaluate and compare the two treatment arms with respect to overall survival (OS)
Time frame: 33 months
To evaluate and compare progression-free survival (PFS) in men with chemotherapy-naïve metastatic HRPC treated with AT-101 in combination with docetaxel and prednisone versus docetaxel and prednisone plus placebo.
Time frame: 33 months
To determine the toxicities associated with oral AT-101 administered in combination with docetaxel and prednisone.
Time frame: 28 months
To evaluate PSA and objective tumor response rate.
Time frame: 28 months
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Unnamed facility
New Port Richey, Florida, United States
Unnamed facility
Ocoee, Florida, United States
Unnamed facility
Fishers, Indiana, United States
Unnamed facility
Burnsville, Minnesota, United States
Unnamed facility
Las Vegas, Nevada, United States
Unnamed facility
Albuquerque, New Mexico, United States
Unnamed facility
Las Cruces, New Mexico, United States
Unnamed facility
Raleigh, North Carolina, United States
Unnamed facility
Kettering, Ohio, United States
...and 25 more locations