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ASSG Endorsed Clinical Study

ASSG11-LDE 225

Title A stratified multi-arm Phase 2 study evaluating the
efficacy and safety of LDE225 in patients with
advanced/metastatic sarcomas
Objective The primary objective is to assess clinical benefit of LDE225 when administered as a single agent; as defined by:
• achievement of complete response (CR) or partial response (PR) during the first 12 weeks of treatment; or
• maintenance of stable disease (SD) until 12 weeks after commencement of treatment as a measure of disease control in adult patients with advanced metastatic sarcomas.
Type Exploratory, non-randomised, 3 cohort, open-label study
Population Men and women aged 18 years or older who have histologically
confirmed metastatic and/or unresectable sarcoma with no known
curative treatment options.
Treatment 800 mg daily LDE225
Phase Ph II
Drug / Intervention 800 mg daily LDE225
Sponsor ASSG
Funding Source ASSG, Novartis
Target accrual 75
Expected Completion 31/03/18
Participating Sites "National Cancer Centre Singapore, Peter MacCallum Cancer Centre, Royal Adelaide, Christchurch
Princess Alexandra, Lifehouse"
Recruitment Status Closed
Numbers Accrued 46
Publications and Presentations Collins M. "Determining drug activity in diseases with multiple subtypes: a comparison of the hierarchical Bayesian approach to Simon’s two-stage design"; Australian Statistical Conference, Adelaide, July 2012, pg 82.
 
Principal Investigator Dr Jayesh Desai
Contact for Further Information Linda Cowan - Trial Manager
Contact Phone Number Linda Cowan (03 9656 3637)
Last update 01-Aug-2017 02:55 PM 

 

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