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Safety and Pharmacokinetics Study of ODM-201 in Castrate Resistant Prostate Cancer

This study has been completed.
Sponsor:
Collaborator:
Endo Pharmaceuticals
Information provided by (Responsible Party):
Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier:
NCT01317641
First received: March 7, 2011
Last updated: February 9, 2017
Last verified: February 2017
  Purpose
The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of ODM-201 in patients with castrate resistant prostate cancer.

Condition Intervention Phase
Prostate Cancer Drug: ODM-201 Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Pharmacokinetics of ODM-201 in Patients With Castrate Resistant Prostate Cancer: Open, Non-randomised, Uncontrolled, Multicentre, Multiple Dose Escalation Study With a Randomised Phase II Expansion Component

Resource links provided by NLM:


Further study details as provided by Orion Corporation, Orion Pharma:

Primary Outcome Measures:
  • Phase 1: Number of Participants Who Experienced Dose Limiting Toxicity (DLT) [ Time Frame: 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 [ Time Frame: 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:
  • Phase 1 and 2: Participants With Decline of at Least 50% in Prostate-specific Antigen (PSA) in Chemotherapy-naïve and CYP17i-naïve Group [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 Response in Soft Tissue in Post-chemotherapy and CYP17i-naive Group [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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: Area Under the Plasma-Concentration-time Curve (AUCt) 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 ]
    AUC(0-8h)

  • 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 [ Time Frame: 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 [ 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 ]

Enrollment: 136
Study Start Date: March 2011
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ODM-201 Phase I Drug: ODM-201
ODM-201 administered orally daily
Experimental: ODM-201 Phase II Dose 1 Drug: ODM-201
ODM-201 administered orally daily
Experimental: ODM-201 Phase II Dose 2 Drug: ODM-201
ODM-201 administered orally daily
Experimental: ODM-201 Phase II Dose 3 Drug: ODM-201
ODM-201 administered orally daily

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01317641

Locations
United States, Colorado
The Urology Center of Colorado
Wheat Ridge, Colorado, United States, 80211
United States, Connecticut
Eastern CT Hematology and Oncology Associates
Norwich, Connecticut, United States, 06360
United States, Florida
Urology Health Team PLLC
Ocala, Florida, United States, 34474
United States, Maryland
Chesapeake Urology Research Associates
Baltimore, Maryland, United States, 21327
United States, New Jersey
Delaware Valley urology, LLC
Voorhees, New Jersey, United States, 08043
United States, New York
Brooklyn Urology Research Group
Brooklyn, New York, United States, 11215
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, South Carolina
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States, 29572
Czech Republic
Klinika onkologie a radioterapie LFUK a FN
Hradec Králové, Czech Republic
Fakultni Nemonicnice Olomouc
Olomouc, Czech Republic
Oddeleni Radiacni a Klinicke Onkologie Nemocnice Znojmo
Znojmo, Czech Republic
Estonia
East-Tallinn Central Hospital
Talinn, Estonia
Finland
Helsinki University Central Hospital
Helsinki, Finland
Kuopio University Hospital
Kuopio, Finland
Oulu University Hospital
Oulu, Finland
Tampere University Hospital
Tampere, Finland
Turku University Hospital
Turku, Finland
France
Saint Louis Hospital
Paris, France
Institut Gustave Roussy
Villejuif, France
United Kingdom
Queen Elizabeth Hospital
Birmingham, United Kingdom
Velindre Cancer Centre
Cardiff, United Kingdom
Christie Hospital
Manchester, United Kingdom
Churchill Hospital
Oxford, United Kingdom
Sponsors and Collaborators
Orion Corporation, Orion Pharma
Endo Pharmaceuticals
Investigators
Principal Investigator: Karim Fizazi Gustave Roussy, Cancer Campus, Grand Paris
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier: NCT01317641     History of Changes
Other Study ID Numbers: 3104001
Study First Received: March 7, 2011
Results First Received: March 23, 2016
Last Updated: February 9, 2017

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on August 18, 2017