Safety and Tolerability of ODM-201 in Castrate Resistant Prostate Cancer; Extension Study to Study 3104001
This study is enrolling participants by invitation only.
Sponsor:
Orion Corporation, Orion Pharma
Collaborator:
Endo Pharmaceuticals
Information provided by (Responsible Party):
Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier:
NCT01429064
First received: September 1, 2011
Last updated: March 14, 2013
Last verified: March 2013
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Purpose
The purpose of this study is to evaluate safety and tolerability of ODM-201 in patients with castrate resistant prostate cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Drug: ODM-201 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Safety and Tolerability of ODM-201 in Patients With Castrate Resistant Prostate Cancer: Open, Non-randomised, Uncontrolled, Multicentre, Extension Study to Study 3104001 |
Resource links provided by NLM:
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: until disease progression, an expected average of 6 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Response in prostate specific antigen (PSA) and in soft and bone tissues [ Time Frame: until disease progression, an expected average of 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 130 |
| Study Start Date: | June 2011 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: ODM-201 |
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
- Successful completion of study protocol 3104001
- Response or stable disease in study 3104001 at week 12
Exclusion Criteria:
- New serious concurrent medical condition
- Not able to swallow the study drug
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01429064
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 | |
| Tallinn, 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: | NCT01429064 History of Changes |
| Other Study ID Numbers: | 3104002 |
| Study First Received: | September 1, 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 |
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 May 16, 2013