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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
March 7, 2011
February 9, 2017
March 2011
July 2013   (Final data collection date for primary outcome measure)
  • 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)
Safety and tolerability assessed by incidence of adverse events, vital signs, 12-lead ECG, laboratory assessments and physical examination [ Time Frame: 3 months ]
Complete list of historical versions of study NCT01317641 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Pharmacokinetics of ODM-201 and its major metabolite [ Time Frame: 28 days ]
  • Response in prostate specific antigen (PSA) and in soft and bone tissues [ Time Frame: 3 months ]
Not Provided
Not Provided
 
Safety and Pharmacokinetics Study of ODM-201 in Castrate Resistant Prostate Cancer
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
The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of ODM-201 in patients with castrate resistant prostate cancer.
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Prostate Cancer
Drug: ODM-201
ODM-201 administered orally daily
  • Experimental: ODM-201 Phase I
    Intervention: Drug: ODM-201
  • Experimental: ODM-201 Phase II Dose 1
    Intervention: Drug: ODM-201
  • Experimental: ODM-201 Phase II Dose 2
    Intervention: Drug: ODM-201
  • Experimental: ODM-201 Phase II Dose 3
    Intervention: Drug: ODM-201
Fizazi K, Massard C, Bono P, Jones R, Kataja V, James N, Garcia JA, Protheroe A, Tammela TL, Elliott T, Mattila L, Aspegren J, Vuorela A, Langmuir P, Mustonen M; ARADES study group. Activity and safety of ODM-201 in patients with progressive metastatic castration-resistant prostate cancer (ARADES): an open-label phase 1 dose-escalation and randomised phase 2 dose expansion trial. Lancet Oncol. 2014 Aug;15(9):975-85. doi: 10.1016/S1470-2045(14)70240-2. Epub 2014 Jun 25.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
136
July 2013
July 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic,   Estonia,   Finland,   France,   United Kingdom,   United States
 
 
NCT01317641
3104001
Yes
Not Provided
Not Provided
Orion Corporation, Orion Pharma
Orion Corporation, Orion Pharma
Endo Pharmaceuticals
Principal Investigator: Karim Fizazi Gustave Roussy, Cancer Campus, Grand Paris
Orion Corporation, Orion Pharma
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP