Trial Information
A Phase II Study of SU011248 for Maintenance Therapy in Hormone Refractory Prostate Cancer After First Line Chemotherapy
Inclusion Criteria:
- Histological or cytological diagnosis of adenocarcinoma of the prostate
- Metastatic or locally recurrent disease not curable with standard therapy
- ECOG performance status 0, 1 or 2
- Prior single agent docetaxel or docetaxel combination chemotherapy with a documented
PSA or imaging response, and no objective evidence of disease progression at study
enrolment
Exclusion Criteria:
- Patients with a history of other invasive cancer, except adequately treated non
- melanoma skin cancer.
- Patients with known brain metastases.
- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to SU011248.
- Other serious intercurrent illness or medical condition that might be aggravated by
protocol treatment.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression Free Survival
Outcome Time Frame:
180 days without evidence of disease progression would be considered clinically worthy of further investigation
Principal Investigator
Bernhard Eigl, M.D.
Investigator Role:
Study Chair
Investigator Affiliation:
Tom Baker Cancer Board
Authority:
Canada: Health Canada
Study ID:
TBCC-0707001
NCT ID:
NCT00550810
Start Date:
October 2007
Completion Date:
November 2012
Related Keywords:
- Prostate Cancer
- Hormone Refractory
- Sutent
- Prostatic Neoplasms