Safety and Tolerability of ODM-201 in Patients With Castrate Resistant Prostate Cancer: Open, Non-randomised, Uncontrolled, Multicentre, Extension Study to Study 3104001
Phase 2
18 Years
N/A
18 Years
N/A
Open (Enrolling by invite only)
Male
Prostate Cancer
Male
Prostate Cancer
Trial Information
Safety and Tolerability of ODM-201 in Patients With Castrate Resistant Prostate Cancer: Open, Non-randomised, Uncontrolled, Multicentre, Extension Study to Study 3104001
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Safety and tolerability assessed by incidence of adverse events, vital signs, 12-lead ECG, laboratory assessments and physical examination
Outcome Time Frame:
until disease progression, an expected average of 6 months
Safety Issue:
Yes
Principal Investigator
Karim Fizazi
Investigator Role:
Principal Investigator
Investigator Affiliation:
Gustave Roussy, Cancer Campus, Grand Paris
Authority:
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study ID:
3104002
NCT ID:
NCT01429064
Start Date:
June 2011
Completion Date:
Related Keywords:
- Prostate Cancer
- Prostatic Neoplasms
Name | Location |
|---|---|
| Cleveland Clinic | Cleveland, Ohio 44195 |
| Carolina Urologic Research Center | Myrtle Beach, South Carolina 29572 |
| Brooklyn Urology Research Group | Brooklyn, New York 11215 |
| The Urology Center of Colorado | Denver, Colorado 80211 |
| Delaware Valley Urology, LLC | Mt. Laurel, New Jersey 08054 |
| Urology of Virginia, PLLC | Virginia Beach, Virginia 23462 |
| Eastern CT Hematology and Oncology Associates | Norwich, Connecticut 06360 |
