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

SARC012

SARC Sponsor and coordinating center

AstraZeneca Supporter

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

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.

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

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