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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Endo Pharmaceuticals
Information provided by (Responsible Party):
Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier:
NCT01317641
First received: March 7, 2011
Last updated: March 14, 2013
Last verified: March 2013
History of Changes
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 130
Study Start Date: March 2011
Estimated Primary Completion Date: June 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
Genders 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
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, 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
United States, Virginia
Urology of Virginia, PLLC
Virginia Beach, Virginia, United States, 23462
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 Institut Gustave Roussy
  More Information

No publications provided

Responsible Party: Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier: NCT01317641     History of Changes
Other Study ID Numbers: 3104001
Study First Received: March 7, 2011
Last Updated: March 14, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Institutional Ethical Committee
Finland: Finnish Medicines Agency
Finland: Ethics Committee
Czech Republic: State Institute for Drug Control
Czech Republic: Ethics Committee
United States: Institutional Review Board
United States: Food and Drug Administration
Estonia: Research Ethics Committee
Estonia: The State Agency of Medicine

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 June 17, 2013