A Phase II Study of SB939 in Patients With Translocation-Associated Recurrent/Metastatic Sarcomas
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.
50mg 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.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
Cross Cancer Institute
Canada: Health Canada