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SARC011 Biology Protocol

This update details the progress of the SARC011 clinical trial as of November 1, 2008. A total of 189 patients have been enrolled, with ongoing consent for the Central BioBank (CBP) at 16 of 28 clinical sites. The protocol involves the collection of unstained FFPE tumor tissue slides and serum samples for genetic and biomarker analysis. Key assays such as IHC and RT-PCR are in development, focusing on IGF-related markers. The trial aims to improve selection strategies for patients likely to respond, pivotal for future therapeutic interventions.

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SARC011 Biology Protocol

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  1. SARC011 Biology Protocol Lee J. Helman, M.D. SARC Biannual Meeting London, Nov 13, 2008

  2. Status Update Reminder-How to select patients most likely to respond! As of Nov 1, 2008 • 189 Pts entered on SARC011 • 44 have consented to CBP • 16 of 28 sites have opened CBP-others in process

  3. SARC011 Sample Flow: Tissue Blocks / Sections for Confirmation of Diagnosis 30 unstained FFPE tumor tissue slides Trial Centers USA MSKCC M Ladanyi C. Antonescu Roche Nutley CSO Trial Centers USA Trial Centers USA Histogenix: IHC assays as per protocol Slides to NCI for Genetic Analysis Barcoded slides Trial Centers EU Trial Centers EU Leiden P. Hogendoorn Roche Basle CSO Trial Centers EU 30 unstained FFPE tumor tissue slides Anticipate receiving ~20 unstained tissue slides for each patient from path labs Confirm histopathology; assess translocations

  4. SARC011 Sample Flow: Serum 3 x 1mL aliquots frozen serum Trial Centers USA Trial Centers USA Nutley CSO Trial Centers USA Ligands, shed receptor Barcoded serum samples Clinical database Results Trial Centers EU Trial Centers EU Basel CSO 3 x 1mL aliquots frozen serum Trial Centers EU All clinical sites to ship serum samples to Roche Central Sample Office (shipping materials provided by Roche) Bioanalytics and serum PD assays to be conducted at CSOs and data submited to central clinical database

  5. Status of Assays • IHC assays for IGFI-R, pAkt, pErk, pmTOR, PTEN released • RT-PCR assays being standardized • ELISA assay for serum IGF-I levels running • Decision made to not perform: • Shed IGF1-R • pIGF1-R IHC (assay not performing) • 12 tissue samples received at NCI for full length IGF1-R seq (limited set), LOI IGF2, p53 and RAS hotspot sequencing, p15/16 deletion

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