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SARC Global Collaboration

SARC Global Collaboration. Activating SARC011/Roche NO21157. SARC011/Roche NO21157. Protocol Steering Committee Approved protocol July 2007 Meeting with FDA Review of proposed study Revision of study endpoints Finalization of protocol September 18, 2007. What is the current status?.

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SARC Global Collaboration

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  1. SARC Global Collaboration Activating SARC011/Roche NO21157

  2. SARC011/Roche NO21157 • Protocol Steering Committee • Approved protocol July 2007 • Meeting with FDA • Review of proposed study • Revision of study endpoints • Finalization of protocol • September 18, 2007

  3. What is the current status? • 75 sites/investigators • 31 US and 44 outside US • Total of 13 countries • Sites per country • US (31), Australia (6), Canada (2), Denmark (1), Finland (1), France (7), Germany (9), Italy (3), Netherlands (2), Norway (1), Spain (5), Sweden (2) and the UK (5) • CDA (confidentiality agreements) signed by 65 sites/investigators • Sites with signed CDA have received: • Protocol • Investigator brochure • Consent form template

  4. Who will be working with sites through regulatory process? • US sites • SARC will assist with PRC/SRC queries • SARC to review consent prior to IRB submission • Outside US • Roche filing of CTA* in EU (mid November 2007) • SARC to assist with Ethic Committee queries • Covance to review consents • Covance to assist with consent/protocol translation • Covance to assist with Canadian and Australian regulatory process *CTA-Clinical Trial Application

  5. What is SARC’s relationship with Covance? • SARC will direct Covance re: site specific activities • Pre-study visits • Secure regulatory documents • Site initiation • Data monitoring • Covance/ClinPhone to develop the database • SARC and Roche direction • Concerns/difficulties communicated to SARC

  6. Who are our contacts at SARC and Covance? • SARC • Research Project Manager • Jessica Reed, PhD • jreed@sarctrials.org • 734-930-7600 • Covance • Project Director • Michelle LaBruyere • michelle.labruyere@covance.com • 615-313-6859

  7. When can our site expect a visit/contact from Covance? • Covance to arrange time to meet • In-person or phone contact • Goal is to complete visits by late November to early December

  8. When will we receive the contract and budget? • Contract and budget complete for US sites • To be sent to US sites week of 11/5/07 • Contract and budget for exUS sites • Country specific • Templates obtained/legal review • Contracts/budgets are being prepared • Modified based on country specifics • Contracts/payments through SARC and sites

  9. Who will be doing contract negotiations? • SARC attorney will negotiate all contracts • Jospeh Nuyen • Nuyen, Tomtishen and Aoun, PC • For outside US • Collaborate with Covance and Roche legal

  10. What will be the reimbursement? • US sites • Per Patient reimbursement • $2000 per patient (enrollment/not screen failures) • Additional $3000 per patient (week 6 tumor assessment) • Additional $3000 per patient (>24 weeks) • Annual reimbursement for each additional year the patient remains on study $1200 per year

  11. Reimbursement (cont’d) • Additional funds to be provided for: • IRB/Investigational drug service (site rate) • Non-standard of care items • PET-site rate • MD visits 4 visits during 1st 6 weeks at $200/visit • PK/PD • Kits/shipping costs • Reimbursement per draw/complete set ($200 per draw for complete set and $400-3 samples/extra visit) • Costs for preparing and shipping tissue samples • Block/slides ($6/slide-40 slides or $300 block) • Preparation and shipping of images for central review • $100 per imaging study sent • ECG central review processing • Provide equipment ($75 per series of 3 x 5)

  12. What will be the reimbursement outside of US? • Based on country regulations and specific requirements • Reimbursement to be aligned across the study for all sites (outside US and US)

  13. How will we get the drug? • US • Roche to send directly to sites • Outside US • Drug to be shipped via a 3rd party distribution center

  14. What steps are needed to activate the study at my site? • Receipt of all regulatory documents • Signed contract • Pre-study visit ensuring all needed processes are in place • ECG • Electronic data capture • Imaging • Study initiation meeting completed

  15. Who will be overseeing the conduct of the trial? • Medical Monitors • Roche • Stan Frankel, MD • Queries related to AE/dosing • SARC • Shreyas Patel, MD • Queries related to patient eligibility, response evaluations, and patient related concerns during course of study • Collaborate/agree on all determinations

  16. When will the study be activated? • Protocol amendment • Human anti-human antibody (HAHA) sampling needs to be added • Require consent update • Submission to IRB prior to activation • Amendment to sites by week of 11/5/07 • Goal for first patient entered • Mid November 2007

  17. SARC Global Collaboration • First opportunity for global collaboration • Seek to successfully navigate logistics • Build network for sarcoma experts globally to collaborate on clinical trial research • Establish processes to be utilized in the future Patience is a Virtue

  18. -Sant Chawla, MD Century City Hospital -Arthur Staddon, MD Pennsylvania Oncology -Amir Shahlaee, MD University of Florida -William Tapp, MD UCLA -Dennis Priebat, MD Washington Cancer Institute -Chris Ryan, MD Oregon Health Science -Margaret Von Mehren, MD Fox Chase -James Whitlock, MD Vanderbilt -Doug Hawkins, MD University of Washington -Kristen Ganjoo, MD Stanford -Albert Pappo, MD* Texas Children’s -Shreyaskumar Patel, MD MDAnderson Cancer Center -Robert Maki, MD, PhD MSKCC -Scott Schuetze, MD, PhD University of Michigan -Lee Helman, MD NCI-Pediatric Branch -Gina D’Amato, MD Moffitt Cancer Center -Nabil Saba, MD Emory -George Demetri, MD Dana Farber -David Harmon, MD Massachusetts General -Scott Okuno, MD Mayo Clinic SARC-011 Potential Investigators

  19. -Kevin Patterson, MD Queen Elizabethl- Australia -Ross Pinkerton, MD Mater Children’s-Australia -Jayesh Desai, MD Royal Melbourne-Australia -David Thomas, MD Peter MacCallum-Australia -Martin Tatersall, MD Prince Alfred, Australia -Geoffrey McCowage, MD Children’s at Westmead-Australia -Martin Blackstein, MD Mt. Sinai –Canada -Margaret Knowling, MD Vancouver Cancer center-Canada -Ole Steel Nielsen,MD Aarhus- Denmark -Heikki Joensuu,MD Helsinki-Finland -Charles Forscher, MD Cedar Sinai -Warren Chow, MD City of Hope -Michael Livingston, MD Carolinas Hem Onc. -Thomas Budd, MD Cleveland Clinic -Kirsten Leu, MD Onc.Hem.West -Richard Gorlick, MD Albert Eistein -Paul Savage,MD Wake Forest -Kimo Stine, MD Arkansas -Brian Samuels, MD Kootenai -R.Lor Randall, MD Huntsman Cancer Institute -David Loeb, MD Johns Hopkins SARC011 Potential Investigators

  20. -Peter Hohenberger, MD Heidelberg-Germany -Herbert Jurgens, MD Wilhelms University-Germany -Wolfgang Berdel, MD Wilhelms University-Germany -Stephan Bielak, MD Olgahospital-Germany -Jorg Hartmann, MD Tubingen-Germany -Piero Picci, MD Isituti Ortopedici Rizzoli-Italy -Stafano Ferrari, MD Isituti Ortopedici Rizzoli-Italy -Paolo Casali, MD Istituto Nazionale Tumori- Italy -Jaap Verwejj, MD Erasmus- Netherlands -Pancras Hogendoorn, MD Leiden-Netherlands -Binh Bui, MD Institut Bergonie-France -Nicholas Penel, MD Centre Oscar Lambert-France -Jean-Yves Blay, MD Centre Leon Berard-France -Florence Duffaud, MD Hopital La Timone-France -Sophie Piperno-Neumann, MD Institut Curie-France -Axel Le Cesne, MD Institut Gustave Roussy-France -Gilles Vassal, MD* Institut Gustave Roussy-France -Peter Reichardt, MD Bad Saarow-Germany Berlin-Germany-Germany -Thomas Klingelbiel, MD Goethe University-Germany -Christian Manegold, MD Heidelberg-Germany SARC011 Potential Investigators

  21. -David Peake, MD University Hospital Birmingham-UK -Bruce Moorland, MD Birmingham Children’s-UK -Mike Leahy, MD Christie Hospital -UK -Beartrice Seddon, MD Middlesex Hospital-UK -Ian Judson, MD Royal Marsden-UK -Sigbjorn Smeland, MD Norwegian Radium- Norway -Jose Antonio Lopez Martin, MD Madrid-Spain -Jaume Mora, MD Sant Joan de Deu-Spain -Xavier Garcia Del Muro, MD Institue Catala d’Oncologia- Spain -Antonio Lopez Pousa,MD Barcelona-Spain -Javier Martin, MD Hospital Son Dureta-Spain -Thor Alvegard, MD Lund University-Sweden -Ake Jakobson, MD Karolinska Institute-Sweden SARC011 Potential Investigators

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