Canadian Cancer Trials Group - Tumour Bank
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I200 Details
Status: Closed 
Activation Date: 2010MAR18
Closing Date: 2012JAN25
Phase: II 

Description: A Phase II Study of SB939 in Patients with Translocation-Associated Recurrent/Metastatic Sarcomas.  

Eligibility: Patients with histologically diagnosed translocation-associated sarcoma. Patients must have measurable disease. A tissue block from primary or metastatic tumour must be available for confirmation of diagnosis, translocation subtype and correlative studies. Up to 1 prior chemotherapy regimen in the metastatic setting is permitted. Prior radiation permitted. No pathologic cardiac arrhythmia within previous 12 months or myocardial infarction within 6 months. Acceptable end-organ function. ECOG 0, 1 or 2. 

Objective: 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. To determine response duration, stable disease rate and progression free survival in these patients. To determine the tolerability and toxicity of SB939 in this population. To explore potential molecular factors predictive of response in formalin fixed paraffin embedded specimens of patient sarcoma tissue. 

Participation: Limited to invited centres 

Lay Description: The main purpose of this study is to find out how effective the study drug SB939 is in treating specific types of sarcoma cancer. Treatment will be SB939 given by mouth every other day for 3 times a week for 3 consecutive weeks followed by one week off. Patients will be those who meet all of the eligibility criteria. Treatment will be repeated every 4 weeks (1 cycle = 4 weeks) and will continue for up to 6 cycles as long as the cancer does not progress and the side effects are not too severe and the patient wishes to. If patients achieve a response to treatment, they may be on the study until the cancer worsens or for up to 12 cycles. 

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Hide Tissue Samples
Disease Site Trial Code Patients Accrued Patients - Blocks Patients - Slides Patients - Blocks and/or Slides
IND I200 24 2 1 2
Hide TMA Samples
(Core size is 0.6 mm)
Disease Site Trial Code Patients Accrued TMA Blocks Patients on TMA Blocks
IND I200 24 1 1
Hide Fluid Samples
Disease Site Trial Code Patients Accrued Patients - Whole Blood Patients - Cellular Component of Blood Patients - DNA extracted from Blood Patients - RNA extracted from Blood Patients - Plasma Patients - Serum Patients - Urine Patients - Buccal
IND I200 24 0 0 0 0 0 0 0 0