A Study of SB939 in Patients With Translocation-Associated Recurrent/Metastatic Sarcomas (IND200)
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of SB939 in Patients With Translocation-Associated Recurrent/Metastatic Sarcomas|
- 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. [ Time Frame: 24 months ] [ Designated as safety issue: No ]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.
- Response duration, stable disease rate and progression free survival in these patients. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Tolerability and toxicity of SB939, according to NCI CTCAE 4.0, in this population [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
- Potential molecular factors predictive of response in formalin fixed paraffin embedded specimens of patient sarcoma tissue [ Time Frame: 24 months ] [ Designated as safety issue: No ]
|Study Start Date:||March 2010|
|Estimated Study Completion Date:||November 2012|
|Estimated Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
- - To determine the efficacy of SB939 in translocation associated sarcoma patients.
- - To determine response duration, stable disease rate and progression free survival.
- - To evaluate toxicity of SB939.
- - 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.
|Tom Baker Cancer Centre|
|Calgary, Alberta, Canada, T2N 4N2|
|Cross Cancer Institute|
|Edmonton, Alberta, Canada, T6G 1Z2|
|Canada, British Columbia|
|BCCA - Vancouver Cancer Centre|
|Vancouver, British Columbia, Canada, V5Z 4E6|
|Juravinski Cancer Centre at Hamilton Health Sciences|
|Hamilton, Ontario, Canada, L8V 5C2|
|London Regional Cancer Program|
|London, Ontario, Canada, N6A 4L6|
|Ottawa Health Research Institute - General Division|
|Ottawa, Ontario, Canada, K1H 8L6|
|Univ. Health Network-Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|McGill University - Dept. Oncology|
|Montreal, Quebec, Canada, H2W 1S6|
|Study Chair:||Quincy Chu||Cross Cancer Institute|