Know Cancer

or
forgot password

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
Open (Enrolling by invite only)
Male
Prostate Cancer

Thank you

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 ClinicCleveland, Ohio  44195
Carolina Urologic Research CenterMyrtle Beach, South Carolina  29572
Brooklyn Urology Research GroupBrooklyn, New York  11215
The Urology Center of ColoradoDenver, Colorado  80211
Delaware Valley Urology, LLCMt. Laurel, New Jersey  08054
Urology of Virginia, PLLCVirginia Beach, Virginia  23462
Eastern CT Hematology and Oncology AssociatesNorwich, Connecticut  06360