The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of ODM-201 in patients with castrate resistant prostate cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
136
ODM-201 administered orally daily
The Urology Center of Colorado
Wheat Ridge, Colorado, United States
Phase 1: Number of Participants Who Experienced Dose Limiting Toxicity (DLT)
A DLT was any Grade 3 or more toxicity (by National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE version 4.03\]) excluding less than Grade 4 neutropenia or thrombocytopenia, hematological toxicity lasting less than 7 days, and nausea, vomiting, diarrhea controlled with antiemetic and/or anti-diarrheal treatment.
Time frame: Up to 28 days for each cohort
Phase 1: Number of Dose Limiting Toxicities Used to Determine the Maximum Tolerated Dose
The MTD is defined as dose level at which 2 or more out of 6 participants experience a dose limiting toxicity (DLT)
Time frame: Up to 28 days for each cohort
Phase 1 and 2: Participants With Decline of at Least 50% in Prostate-specific Antigen (PSA) in Chemotherapy-naïve and CYP17i-naïve Group
Number of participants with greater than or equal to 50% decrease in serum PSA from baseline at 12 weeks in group of participants who were naïve to both chemotherapy and CYP17 inhibitor
Time frame: 3 months
Phase 1 and 2: Participants With Decline of at Least 50% in Prostate-specific Antigen (PSA) in Post-chemotherapy and CYP17i-naïve Group
Number of participants with greater than or equal to 50% decrease in serum PSA from baseline at 12 weeks in group of participants previously treated with chemotherapy but not CYP17 inhibitor
Time frame: 3 months
Phase 1 and 2: Participants With Decline of at Least 50% in Prostate-specific Antigen (PSA) in Post-CYP17i Group
Number of participants with greater than or equal to 50% decrease in serum PSA from baseline at 12 weeks in group of participants previously treated with CYP17 inhibitor
Time frame: 3 months
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Eastern CT Hematology and Oncology Associates
Norwich, Connecticut, United States
Urology Health Team PLLC
Ocala, Florida, United States
Chesapeake Urology Research Associates
Baltimore, Maryland, United States
Delaware Valley urology, LLC
Voorhees Township, New Jersey, United States
Brooklyn Urology Research Group
Brooklyn, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States
Klinika onkologie a radioterapie LFUK a FN
Hradec Králové, Czechia
Fakultni Nemonicnice Olomouc
Olomouc, Czechia
...and 13 more locations
Phase 1 and 2: Participants With RECIST Response in Soft Tissue in Chemotherapy-naïve and CYP17i-naïve Group
Number of participants with overall complete response (CR), partial response (PR) or stable (SD) soft tissue disease according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) in chest, abdomen, and pelvic CT or MRI scans.
Time frame: 3 months
Phase 1 and 2: Participants With RECIST Response in Soft Tissue in Post-chemotherapy and CYP17i-naive Group
Number of participants with overall complete response (CR), partial response (PR) or stable (SD) soft tissue disease according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) in chest, abdomen, and pelvic CT or MRI scans.
Time frame: 3 months
Phase 1 and 2: Participants With RECIST Responses in Soft Tissue in Post-CYP17i Group
Number of participants with overall complete response (CR), partial response (PR) or stable (SD) soft tissue disease according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) in chest, abdomen, and pelvic CT or MRI scans.
Time frame: 3 months
Phase 1 and 2: Participants With Stable Bone Disease in Chemotherapy-naïve and CYP17i-naïve Group
Number of participants with stable bone disease (no change). Radiographic bone progression was defined by the appearance of two or more new lesions on bone scan
Time frame: 3 months
Phase 1 and 2: Participants With Stable Bone Disease in Post-chemotherapy and CYP17i-naïve Group
Number of participants with stable bone disease (no change). Radiographic bone progression was defined by the appearance of two or more new lesions on bone scan
Time frame: 3 months
Phase 1 and 2: Participants With Stable Bone Disease in Post-CYP17i Group
Number of participants with stable bone disease (no change). Radiographic bone progression was defined by the appearance of two or more new lesions on bone scan
Time frame: 3 months
Phase 1: Area Under the Plasma-Concentration-time Curve (AUCt) of ODM-201 at Steady-state
AUC(0-8h)
Time frame: Day 8 predose 0 h and 0.5, 1, 1.5, 2, 4, 6 and 8 h postdose
Phase 1: Maximum Plasma Concentration (Cmax) of ODM-201 at Steady-state
Time frame: Day 8 predose 0 h and 0.5, 1, 1.5, 2, 4, 6 and 8 h postdose
Phase 1: Time to Reach the Maximum Observed Concentration (Tmax) of ODM-201 at Day 1
Time frame: 1 day
Phase 1: Area Under the Plasma-Concentration-time Curve (AUCt) of Major Metabolite ORM-15341 at Steady-state
AUC(0-8h)
Time frame: Day 8 predose 0 h and 0.5, 1, 1.5, 2, 4, 6 and 8 h postdose
Phase 1: Maximum Plasma Concentration (Cmax) of Major Metabolite ORM-15341 at Steady-state
Time frame: Day 8 predose 0 h and 0.5, 1, 1.5, 2, 4, 6 and 8 h postdose
Phase 1: Time to Reach the Maximum Observed Concentration (Tmax) of Major Metabolite ORM-15341 at Day 1
Time frame: 1 day