Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
30 participants
INTERVENTIONAL
2007-10-31
2012-11-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Sunitinib (SU011248)
SU011248 (study medication) will be given at 50 mg/day as a single agent for 4 consecutive weeks followed by a 2 week rest period to form a complete cycle of 6 weeks. Study medication will be orally self administered once daily without regard to meals beginning on Day 1 of the study. Cycles will be repeated in the absence of unacceptable toxicity or disease progression
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
MALE
No
Sponsors
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Pfizer
INDUSTRY
Alberta Health services
OTHER
Responsible Party
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Rachel Syme
Dr. Bernie Eigl
Principal Investigators
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Bernhard Eigl, M.D.
Role: STUDY_CHAIR
Tom Baker Cancer Board
Locations
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Tom Baker Cancer Centre
Calgary, Alberta, Canada
Cross Cancer Institute
Edmonton, Alberta, Canada
Vancouver Cancer Centre
Vancouver, British Columbia, Canada
London Health Sciences Centre
London, Ontario, Canada
Countries
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Other Identifiers
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SMART
Identifier Type: -
Identifier Source: secondary_id
TBCC-0707001
Identifier Type: -
Identifier Source: org_study_id