A Phase II Study of SU011248 for Maintenance Therapy in Hormone Refractory Prostate Cancer After First Line Chemotherapy
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Alberta Health services
- Enrollment
- 30
- Locations
- 4
- Primary Endpoint
- Progression Free Survival
Study Overview
Brief Summary
The major goal is to determine whether the experimental agent has clinically promising activity that would merit progression to a formal phase III trial.
Patients with hormone refractory prostate cancer after docetaxel chemotherapy have limited treatment options and no systemic treatment has been proven to be effective. Because of its action, safety and simple administration SU011248 has potential for effectiveness in this disease setting. Promising activity in this study would provide the necessary proof-of-principle for a larger confirmatory study in this population, and potentially in earlier stages of this common disease.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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 SU
- •Other serious intercurrent illness or medical condition that might be aggravated by protocol treatment.
Outcomes
Primary Outcomes
Progression Free Survival
Time Frame: 180 days without evidence of disease progression would be considered clinically worthy of further investigation
Secondary Outcomes
- -PSA Response -Toxicity(The secondary endpoint of PSA response will also be documented. PSA response is defined as a ≥50% fall in PSA (minimum of 5 µg/L) from baseline maintained for > 3 weeks and without evidence of disease progression otherwise.)
Investigators
Rachel Syme
Dr. Bernie Eigl
Alberta Health services