a randomized, double-blinded, placebo- controlled, multi-institutional, cross-over phase ii.5 study...
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A Randomized, Double-Blinded, Placebo-Controlled, Multi-Institutional, Cross-Over
Phase II.5 Study of Saracatinib, a Selective Src Kinase Inhibitor, in Patients with Recurrent
Osteosarcoma Localized to the Lung
Principal Investigator:
Melinda Merchant, MD, PhDPediatric Oncology Branch
National Cancer Institute, National Institutes of Health
SARC012
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SARC012
SARC Sponsor and coordinating center
AstraZeneca Supporter
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SARC012
Background Phase II.5 study of saracatinib in recurrent
osteosarcoma localized to the lung 2012 protocol amended to allow cross-over if
progression on placebo June 2013 IDMC recommended study remain
open to interim analysis
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SARC012
Resection of all remaining nodules, verification of recurrent osteosarcoma
Randomized to receive saracatinib or placebo continuous (364 days/13 cycles)
Thoracic CT Wk 3-4, 6-8; then every 3 months
Complete 13 cycles
Study Follow up
Recur in lung while on study
Unblinding Patients on placebo mayundergo another resection, and if fully
resected, will be given option to receive saracatinib for 13 cycles.
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SARC012 Study Sites
Sites Open for Enrollment National Cancer Institute Stanford University of Alabama University of Michigan UCLA Sarcoma Oncology Ctr U of Wash –Seattle CC St. Jude’s Johns Hopkins
University of Iowa Cincinnati Children’s Hospital Dana Farber Dana Farber Partners CC University of Miami University of Florida Children’s Hospital LA USC
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Study Status
Enrollment n= 43
Randomized pts n= 36
On study treatment n= 5
Off study n= 22
In follow-up n= 7
Cross over n= 2
Goal for Interim Analysis n= 40 Randomized patients