NCT01112384

A Study of SB939 in Patients With Translocation-Associated Recurrent/Metastatic Sarcomas

A Phase II Study of SB939 in Patients With Translocation-Associated Recurrent/Metastatic Sarcomas

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: NCIC Clinical Trials Group · Network
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Metastatic Sarcoma

Interventions

Type	Name	Description
DRUG	SB939	Given orally 3 times per week

Timeline

• Start date: 2010-10-21
• Primary completion: 2013-01-21
• Completion: 2014-01-16
• First posted: 2010-04-28
• Last updated: 2023-08-04

Locations

8 sites across 1 country: Canada