This is a multicenter phase 2 open-label single-arm study that will evaluate the safety and efficacy of TAK-700 in patients with castration-resistant prostate cancer (CRPC) without radiographic evidence of metastases who have a rising prostate-specific antigen (PSA).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
38
TAK-700 will be administered orally (PO) twice daily (BID) on a continuous schedule
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Oregon Health and Sciences University
Portland, Oregon, United States
University of Wisconsin Hospitals and Clinics
Madison, Wisconsin, United States
To determine the percentage of patients who achieve a PSA less than or equal to 0.2 ng/mL following 3 months of TAK-700 treatment
Time frame: 3 months
To determine PSA response rate (PSA decline of at least 90%, 50% and 30% from baseline)at 3 and 6 months
Time frame: 3 and 6 months
To determine the percentage of patients who achieve a PSA less than or equal to 0.2 ng/mL following 6 months of TAK-700 treatment
Time frame: 6 months
To determine time to PSA progression, time to metastases, and duration of progression-free survival
Time frame: Evidence of PSA or disease progression
To monitor changes in endocrine markers
Time frame: Evidence of PSA or disease progression
To evaluate the safety of TAK-700
Time frame: Evidence of PSA or disease progression
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