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: October 20, 2014
Last verified: October 2014

March 7, 2011
October 20, 2014
March 2011
July 2013   (final data collection date for primary outcome measure)
Safety and tolerability assessed by incidence of adverse events, vital signs, 12-lead ECG, laboratory assessments and physical examination [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01317641 on ClinicalTrials.gov Archive Site
  • Pharmacokinetics of ODM-201 and its major metabolite [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Response in prostate specific antigen (PSA) and in soft and bone tissues [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   United Kingdom,   Estonia,   Czech Republic,   Finland,   France
 
NCT01317641
3104001
Yes
Orion Corporation, Orion Pharma
Orion Corporation, Orion Pharma
Endo Pharmaceuticals
Principal Investigator: Karim Fizazi Gustave Roussy, Cancer Campus, Grand Paris
Orion Corporation, Orion Pharma
October 2014

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