The purpose of this study is to determine whether TOK-001 is safe and shows biological effect in the treatment of castration resistant prostate cancer (CRPC).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
49
UCLA
Los Angeles, California, United States
San Bernardino Urological Associates
San Bernardino, California, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Dana Farber Cancer Institute
Phase 1: Incidence of adverse events
Safety will be assessed by incidence of AEs and change from baseline in the following additional safety parameters: clinical laboratory assessments, physical examination, vital signs, and 12 lead electrocardiograms (ECGs)
Time frame: 3 months
Efficacy Measures
Efficacy will be assessed by evaluation of change in PSA level, changes from baseline in CT/MRI and bone scans, response rate RECIST criteria and additional special laboratories
Time frame: 3 months
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3 capsules (325 mg each), once per day
3 capsules (325 mg each), once per day with supplement
6 capsules (325 mg each), split dose (3 capsules with breakfast, 3 capsules with dinner)
8 capsules (325 mg each), once per day
8 capsules (325 mg each), split dose (4 capsules with breakfast, 4 capsules with dinner)
Boston, Massachusetts, United States
Comprehensive Cancer Centers of Nevada & US Oncology Research
Las Vegas, Nevada, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Greenville Hospital System University Medical Center
Greenville, South Carolina, United States
University of Washington/Seattle Cancer Care Alliance
Seattle, Washington, United States