The purpose of this study is to find out what effects a new drug SB939 has on you and your sarcoma. This research is being done because there is a need for better treatment options for advanced or recurring sarcoma. SB939 has been shown to shrink tumours in animals and some people and seems promising but it is not clear if it has any positive effects in sarcoma.
Objectives: 1. \- To determine the efficacy of SB939 in translocation associated sarcoma patients. 2. \- To determine response duration, stable disease rate and progression free survival. 3. \- To evaluate toxicity of SB939. 4. \- To investigate potential molecular factors predictive of response. 60mg SB939 will be given every other day 3 times a week for 3 weeks followed by a week off. Patients may receive a maximum of 12 cycles if they have a response to treatment in the absence of disease progression or unacceptable toxicity. Patients with stable disease may continue therapy for a maximum of 6 cycles.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Given orally 3 times per week
Tom Baker Cancer Centre
Calgary, Alberta, Canada
Cross Cancer Institute
Edmonton, Alberta, Canada
BCCA - Vancouver Cancer Centre
Vancouver, British Columbia, Canada
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, Canada
To determine the efficacy (as measured by objective response) of SB939 when given orally every other day 3 times a week, in patients with translocation-associated sarcomas.
The primary endpoint of this study is objective tumour response using RECIST 1.1 \[Eisenhauer 2009\]. Response is defined as 30% decrease in the sum of the diameters of the target lesions (partial response) maintained for at least 4 weeks, or complete disappearance of disease and cancer related symptoms (complete response), also maintained for at least 4 weeks. The median and range of the duration of response will be assessed. A 95% confidence interval for the true objective response rate will be given.
Time frame: 24 months
Response duration, stable disease rate and progression free survival in these patients.
Time frame: 24 months
Tolerability and toxicity of SB939, according to NCI CTCAE 4.0, in this population
Time frame: 24 months
Potential molecular factors predictive of response in formalin fixed paraffin embedded specimens of patient sarcoma tissue
Time frame: 24 months
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London Regional Cancer Program
London, Ontario, Canada
Ottawa Health Research Institute - General Division
Ottawa, Ontario, Canada
Univ. Health Network-Princess Margaret Hospital
Toronto, Ontario, Canada
McGill University - Dept. Oncology
Montreal, Quebec, Canada