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?• 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

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

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

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

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

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

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

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

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)

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)

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

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

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

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

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

SARC-011 Potential Investigators-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, MDMDAnderson Cancer Center

-Robert Maki, MD, PhD MSKCC

-Scott Schuetze, MD, PhDUniversity of Michigan

-Lee Helman, MD NCI-Pediatric Branch

-Gina D’Amato, MDMoffitt Cancer Center

-Nabil Saba, MDEmory

-George Demetri, MD Dana Farber

-David Harmon, MDMassachusetts General

-Scott Okuno, MDMayo Clinic

-Kevin Patterson, MDQueen Elizabethl- Australia

-Ross Pinkerton, MDMater Children’s-Australia

-Jayesh Desai, MDRoyal Melbourne-Australia

-David Thomas, MDPeter MacCallum-Australia

-Martin Tatersall, MDPrince Alfred, Australia

-Geoffrey McCowage, MDChildren’s at Westmead-Australia

-Martin Blackstein, MD Mt. Sinai –Canada

-Margaret Knowling, MDVancouver Cancer center-Canada

-Ole Steel Nielsen,MDAarhus- Denmark

-Heikki Joensuu,MDHelsinki-Finland

-Charles Forscher, MDCedar Sinai

-Warren Chow, MDCity of Hope

-Michael Livingston, MDCarolinas Hem Onc.

-Thomas Budd, MDCleveland Clinic

-Kirsten Leu, MDOnc.Hem.West

-Richard Gorlick, MDAlbert Eistein

-Paul Savage,MDWake Forest

-Kimo Stine, MDArkansas

-Brian Samuels, MDKootenai

-R.Lor Randall, MDHuntsman Cancer Institute

-David Loeb, MDJohns Hopkins

SARC011 Potential Investigators

-Peter Hohenberger, MDHeidelberg-Germany

-Herbert Jurgens, MDWilhelms University-Germany

-Wolfgang Berdel, MDWilhelms University-Germany

-Stephan Bielak, MDOlgahospital-Germany

-Jorg Hartmann, MDTubingen-Germany

-Piero Picci, MD Isituti Ortopedici Rizzoli-Italy

-Stafano Ferrari, MD Isituti Ortopedici Rizzoli-Italy

-Paolo Casali, MDIstituto Nazionale Tumori- Italy

-Jaap Verwejj, MDErasmus- Netherlands

-Pancras Hogendoorn, MDLeiden-Netherlands

-Binh Bui, MDInstitut Bergonie-France

-Nicholas Penel, MDCentre Oscar Lambert-France

-Jean-Yves Blay, MDCentre Leon Berard-France

-Florence Duffaud, MDHopital La Timone-France

-Sophie Piperno-Neumann, MDInstitut Curie-France

-Axel Le Cesne, MDInstitut Gustave Roussy-France

-Gilles Vassal, MD* Institut Gustave Roussy-France

-Peter Reichardt, MDBad Saarow-GermanyBerlin-Germany-Germany

-Thomas Klingelbiel, MDGoethe University-Germany

-Christian Manegold, MDHeidelberg-Germany

SARC011 Potential Investigators

-David Peake, MDUniversity Hospital Birmingham-UK

-Bruce Moorland, MDBirmingham Children’s-UK

-Mike Leahy, MDChristie Hospital -UK

-Beartrice Seddon, MDMiddlesex Hospital-UK

-Ian Judson, MDRoyal Marsden-UK

-Sigbjorn Smeland, MDNorwegian Radium- Norway

-Jose Antonio Lopez Martin, MDMadrid-Spain

-Jaume Mora, MDSant Joan de Deu-Spain

-Xavier Garcia Del Muro, MDInstitue Catala d’Oncologia- Spain

-Antonio Lopez Pousa,MDBarcelona-Spain

-Javier Martin, MDHospital Son Dureta-Spain

-Thor Alvegard, MD Lund University-Sweden

-Ake Jakobson, MDKarolinska Institute-Sweden

SARC011 Potential Investigators