Safety and Pharmacokinetics Study of ODM-201 in Castrate Resistant Prostate Cancer
- Conditions
- Prostate Cancer
- Interventions
- Drug: ODM-201
- Registration Number
- NCT01317641
- Lead Sponsor
- Orion Corporation, Orion Pharma
- Brief Summary
The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of ODM-201 in patients with castrate resistant prostate cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 136
- Written informed consent
- Histologically confirmed adenocarcinoma of prostate
- Ongoing androgen deprivation therapy with a LHRH analogue or antagonist or bilateral orchiectomy
- Progressive metastatic disease
- Adequate bone marrow, hepatic, and renal function
- Known metastases in the brain
- History of other malignancy within the previous 5 years
- Known gastrointestinal disease or procedure that affects the absorption
- Not able to swallow the study drug
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ODM-201 Phase II Dose 3 ODM-201 - ODM-201 Phase I ODM-201 - ODM-201 Phase II Dose 1 ODM-201 - ODM-201 Phase II Dose 2 ODM-201 -
- Primary Outcome Measures
Name Time Method Phase 1: Number of Participants Who Experienced Dose Limiting Toxicity (DLT) Up to 28 days for each cohort 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.
Phase 1: Number of Dose Limiting Toxicities Used to Determine the Maximum Tolerated Dose Up to 28 days for each cohort The MTD is defined as dose level at which 2 or more out of 6 participants experience a dose limiting toxicity (DLT)
- Secondary Outcome Measures
Name Time Method Phase 1 and 2: Participants With Decline of at Least 50% in Prostate-specific Antigen (PSA) in Chemotherapy-naïve and CYP17i-naïve Group 3 months 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
Phase 1 and 2: Participants With Decline of at Least 50% in Prostate-specific Antigen (PSA) in Post-chemotherapy and CYP17i-naïve Group 3 months 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
Phase 1 and 2: Participants With Decline of at Least 50% in Prostate-specific Antigen (PSA) in Post-CYP17i Group 3 months 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
Phase 1 and 2: Participants With RECIST Response in Soft Tissue in Chemotherapy-naïve and CYP17i-naïve Group 3 months 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.
Phase 1 and 2: Participants With RECIST Responses in Soft Tissue in Post-CYP17i Group 3 months 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.
Phase 1: Area Under the Plasma-Concentration-time Curve (AUCt) of ODM-201 at Steady-state Day 8 predose 0 h and 0.5, 1, 1.5, 2, 4, 6 and 8 h postdose AUC(0-8h)
Phase 1: Maximum Plasma Concentration (Cmax) of ODM-201 at Steady-state 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 1 day Phase 1: Area Under the Plasma-Concentration-time Curve (AUCt) of Major Metabolite ORM-15341 at Steady-state Day 8 predose 0 h and 0.5, 1, 1.5, 2, 4, 6 and 8 h postdose AUC(0-8h)
Phase 1: Maximum Plasma Concentration (Cmax) of Major Metabolite ORM-15341 at Steady-state 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 1 day Phase 1 and 2: Participants With RECIST Response in Soft Tissue in Post-chemotherapy and CYP17i-naive Group 3 months 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.
Phase 1 and 2: Participants With Stable Bone Disease in Chemotherapy-naïve and CYP17i-naïve Group 3 months 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
Phase 1 and 2: Participants With Stable Bone Disease in Post-chemotherapy and CYP17i-naïve Group 3 months 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
Phase 1 and 2: Participants With Stable Bone Disease in Post-CYP17i Group 3 months 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
Trial Locations
- Locations (23)
Chesapeake Urology Research Associates
🇺🇸Baltimore, Maryland, United States
Oddeleni Radiacni a Klinicke Onkologie Nemocnice Znojmo
🇨🇿Znojmo, Czech Republic
Oulu University Hospital
🇫🇮Oulu, Finland
Turku University Hospital
🇫🇮Turku, Finland
Klinika onkologie a radioterapie LFUK a FN
🇨🇿Hradec Králové, Czech Republic
Tampere University Hospital
🇫🇮Tampere, Finland
Delaware Valley urology, LLC
🇺🇸Voorhees, New Jersey, United States
Helsinki University Central Hospital
🇫🇮Helsinki, Finland
East-Tallinn Central Hospital
🇪🇪Talinn, Estonia
Churchill Hospital
🇬🇧Oxford, United Kingdom
Queen Elizabeth Hospital
🇬🇧Birmingham, United Kingdom
The Urology Center of Colorado
🇺🇸Wheat Ridge, Colorado, United States
Brooklyn Urology Research Group
🇺🇸Brooklyn, New York, United States
Fakultni Nemonicnice Olomouc
🇨🇿Olomouc, Czech Republic
Kuopio University Hospital
🇫🇮Kuopio, Finland
Eastern CT Hematology and Oncology Associates
🇺🇸Norwich, Connecticut, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Carolina Urologic Research Center
🇺🇸Myrtle Beach, South Carolina, United States
Saint Louis Hospital
🇫🇷Paris, France
Institut Gustave Roussy
🇫🇷Villejuif, France
Christie Hospital
🇬🇧Manchester, United Kingdom
Velindre Cancer Centre
🇬🇧Cardiff, United Kingdom
Urology Health Team PLLC
🇺🇸Ocala, Florida, United States