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A Phase II Study of SU011248 for Maintenance Therapy in Hormone Refractory Prostate Cancer After First Line Chemotherapy


Phase 2
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer, Hormone Refractory

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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

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