cancer trials ireland -...

www.cancertrials.ie www.cancertrials.ie

Cancer Trials Ireland (formerly: ICORG, Irish Clinical Oncology Research Group)

60 Fitzwilliam Square Dublin 2, Ireland

Presenter : Dr Linda Coate, Consultant Medical Oncologist,

Chair of Lung Disease Specific Sub-Group

TACT meeting: 3 June 2016

http://www.cancertrials.ie/



Cancer Trials Ireland - Brief History

• Founded 1996 – As ICORG

• Investigator owned and run not-for-profit oncology clinical trials organisation – Charity Status

• As of early 2016 Cancer Trials Ireland has over 500 members, including more than 95% of the Island’s cancer treating consultants:

Medical Oncologists – Majority with US Training

Surgeons

Radiation Oncologists

Urologists

Membership continues to grow

Confidential – Cancer Trials Ireland use only




Cancer Trials Ireland - Brief History

• Highly experienced in both Clinical & Translational studies

• Over 15,000 Pts accrued to over 350 Trials – to end 2015

• 2015 Patient Breakdown

2,151 Pts accrued

4,576 Pts still on follow-up

Total of 6,727 Pts active





On May 19th 2016 ICORG Became

Cancer Trials Ireland




Cancer Trials Ireland Mission Statement

‘To foster the growth of clinical trials

activity and scientific research in cancer on the island of Ireland, and in

the long-term to improve survival among Irish cancer patients’




Cancer Trials Ireland Organogram

Cancer Trials Ireland Board

Chief Executive Officer

(CEO)

Clinical Program

Mangement

Clinical Program Leaders

CPMs

SCRAs

CRA I/IIs

tCRAs

CTAs

Quality & Training

Q & T Manager

Q & T Associate

Ethics & Regulatory

Coordinator

Pharmaco-Vigilance

PhV Manager

PhV Associate

tPhV Associate

Data Management

DM Team Leader

Database Analyst

Data Manager

Data Entry Associate

Statistics

Statistician

Human Resources

HR Consultant

Finance

Finance Controller

Trainee Accountant

Admin

Office Administrator

Red = Functional Areas Blue = Current /New Positions

Currently 48 staff





Cancer Trials Ireland Study Flow/Operations

7

Study Concept

Source of Study: In-House

Source of Study: Collaborative Group Industry

Study Protocol

• Study Feasibility • Budget Development • Funding Application/Contract Negotiations

Lung DSSG Approval

Yes External Peer

Review (In-House Studies)

No/Stop/Revise

SMG Approval

Study Approved for Development/Participation

DSSG=Disease Site Specific Group SMG=Scientific Management Group





How is Cancer Trials Ireland funded in 2016?

.





Cancer Trials Ireland accrual 2015 – by disease area

Source: Cancer Trials Ireland Activity Report 2015.





Trial Activity & Accrual in Lung Portfolio 2015-16

2015 = 70 patients 2016 Lung Group portfolio summary:

• 26 potential/ongoing studies discussed in 2016

7 studies currently open

14 potential studies / studies in development / start up

5 discussed studies not to be opened/ not going ahead





Data Management & Statistical support

• Cancer Trials Ireland has its own Data Management team (Medidata RAVE technology) and Group Statistician for industry supported Investigator Initiated Trials

• Cancer Trials Ireland collaborates with the CRFG Data Management & Statistics Group in Ireland on Investigator initiated trials which are supported by the Health Research Board





Key studies in thoracic cancer completed and/or ongoing




Referral Model

Phase III study of crizotinib versus pemetrexed or docetaxel chemotherapy in patients

with advanced ALK-positive non-small cell lung cancer (NSCLC)

2862, ESMO 2012, Late-Breaking Abstract

A.T. Shaw1, D.W. Kim2, K. Nakagawa3, T. Seto4, L. Crinò5, M.-J. Ahn2, T. De Pas6, B. Besse7, B.

Solomon8, F.H. Blackhall9, Y.-L. Wu10, M. Thomas11, K.J. O'Byrne12, D. Moro-Sibilot13, R.

Camidge14, V. Hirsh15, T.S.K. Mok16, V. Tassell17, A. Polli6, P. Jänne1; 1Boston, MA/US, 2Seoul/KR, 3Osaka/JP, 4Fukuoka/JP, 5Perugia/IT, 6Milano/IT, 7Villejuif/FR, 8Melbourne/AU, 9Manchester/UK, 10Guangzhou/CN, 11Heidelberg/DE, 12Dublin/IE, 13Grenoble/FR, 14Aurora,

CO/US, 15Montreal, QC/CA, 16Hong Kong/HK, 17La Jolla, CA/US

• Patients from all Cancer Trials Ireland sites were referred to the one study centre (Prof K.O’Byrne) for ALK mutation testing.

• The Group accrued 8 patients in Ireland, exceeding the target of 5.

• 2nd highest recruiter in Europe

• 7th highest recruiter in World





Referral Model

A Phase III, Multicenter, Randomized, open-label Study in Adult

Patients With ALK rearranged (ALK positive) advanced Non-small

Cell Lung Cancer who have been treated previously with

chemotherapy (platinum doublet) and crizotinib

• Opened at 2 hospital sites in Ireland – patients referred from other Irish

sites

• The Group recruited 6 patients in Ireland (exceeding target of 5)





ETOP BELIEF trial

European Journal of Cancer Volume 51, Supplement 3, September 2015, Pages S711–S712

A phase II trial of erlotinib (E) and bevacizumab (B) in patients with advanced non-small-cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations with and without T790M mutation. The Spanish Lung Cancer Group (SLCG) and the European Thoracic Oncology Platform (ETOP) BELIEF trial R.A. Stahel, U. Dafni, O. Gautschi, E. Felip, A. Curioni-Fontecedro, S. Peters, B. Massutí, F. Cardenal, S.P. Aix, M. Früh, M. Pless, S. Popat, A. Kotsakis, S. Cuffe, P. Bidoli, A. Favaretto, E. Carcereny, M. Sanchez Ronco, M.A. Molina, R. Rosell

________________________________________________________ • 6 patients were randomised to this study in Ireland • Group Chief Investigator Authorship




http://www.sciencedirect.com/science/journal/09598049

http://www.sciencedirect.com/science/journal/09598049

http://www.sciencedirect.com/science/journal/09598049/51/supp/S3

http://www.sciencedirect.com/science/article/pii/S095980491530068X







































ETOP EMPHASIS trial

Journal of Clinical Oncology, 2015 ASCO Annual Meeting (May 29 - June 2, 2015). Vol 33, No 15_suppl (May 20 Supplement), 2015: 8049 © 2015 American Society of Clinical Oncology

Randomized phase III trial of erlotinib vs. docetaxel in patients with advanced squamous cell non-small cell lung cancer (SqNSCLC) failing first line platinum based doublet chemotherapy stratified by VeriStrat Good vs VeriStrat Poor: The European Thoracic Oncology Platform (ETOP) EMPHASIS trial.

Solange Peters, Egbert F. Smit, Urania Dafni, Santiago Ponce Aix, Bartomeu Massuti, Oliver Gautschi, Linda Coate, Ana López Martín, Robbert van Heemst, Thierry Berghmans, Peter Meldgaard, Manuel Cobo Dols, Javier Garde Noguera, Irene Claudia Floriani, Marie Kassapian, Yojena Chittazhathu Kurian Kuruvilla, Adriana Gasca-Ruchti, Christoph Zielinski, Vanesa Gregorc, Rolf A. Stahel and EMPHASIS Collaborative GroupUniversity Hospital of Lausanne (CHUV), Lausanne, Switzerland; Cancer Center Amsterdam, Department of Pulmonary Diseases, VU University Medical Center, Amsterdam, Netherlands; Frontier Science Foundation-Hellas & University of Athens, Athens, Greece; Hospital 12 de Octubre, Madrid, Spain; Alicante University Hospital, Alicante, Spain; Cantonal Hospital Lucerne and Swiss Group for Clinical Cancer Research SAKK, Luzern, Switzerland; Mid-Western Regional Hospital, Limerick, Ireland; Hospital Universitario Severo Ochoa, Madrid, Spain; Deventer Ziekenhuis, Deventer, Netherlands; Institut Jules Bordet, Brussels, Belgium; Aarhus University Hospital, Aarhus, Denmark; Hospital Universitario Regional y Virgen de la Victoria Málaga, Málaga, Spain; Hospital Arnau Vilanova Valencia, Valencia, Spain; Istituto di Ricerche Farmacologiche Mario Negri, Milano, Italy; Frontier Science Foundation-Hellas, Athens, Greece; European Thoracic Oncology Platform (ETOP) Coordinating Office, Bern, Switzerland; Medical University Vienna - General Hospital, Vienna, Austria; Department of Oncology, San Raffaele Scientific Institute, Milan, Italy; University Hospital Zurich, Zurich, Switzerland ______________________________________________________________________________________________________

• 8 patients were randomised to this study in Ireland • Group Chief Investigator authorship




http://jco.ascopubs.org/site/misc/Terms_and_Cond.xhtml


Ongoing lung studies

ETOP SPLENDOUR:

A randomized phase III trial evaluating the addition of denosumab to

standard first-line anticancer treatment in advanced NSCLC

• Open and ongoing at 10 sites in Ireland

• Current accrual: 19 patients

EORTC 1416 PEARLS:

Immunotherapy with anti-PD-1 monoclonal antibody (pembrolizumab) versus placebo for patients with early NSCLC After Resection and completion of standard adjuvant therapy: A randomized double blind phase III trial in Lung cancer (The PEARLS trial)

• Irish sites are currently being activated by CRO

• 1 Irish site open: 1 patient accrued to date





Cancer Trials Ireland - Collaborators




http://gcig.igcs.org/index.html

http://unclineberger.org/

http://www.breastinternationalgroup.org/

http://www.google.ie/url?sa=i&rct=j&q=&esrc=s&source=images&cd=&cad=rja&uact=8&ved=0CAcQjRxqFQoTCP6XltaT9scCFUss2wodgfMETw&url=http://www.cmocro.com/company/PrECOG+LLC/index.html&bvm=bv.102537793,d.ZGU&psig=AFQjCNEMW9wby3t9o7h4vR6mG7X7O7fRmg&ust=1442307319742043

https://www.google.ie/url?sa=i&rct=j&q=&esrc=s&source=images&cd=&cad=rja&uact=8&ved=0CAcQjRxqFQoTCOGa5Z6W9scCFYOz2wod_9MGIA&url=https://www.anzup.org.au/&psig=AFQjCNEJbx45K4SOiOgZ2Km8kOnFhudljg&ust=1442308025634620

http://www.google.ie/url?sa=i&rct=j&q=&esrc=s&source=images&cd=&cad=rja&uact=8&ved=0CAcQjRxqFQoTCM2FjqWq_scCFQI4FAodIHoKVQ&url=http://www.oncosat.com/liens/liens.asp&psig=AFQjCNGVa-z2nmaSjK3d4ndLqI4bs6yOTQ&ust=1442588283862955


Cancer Trials Ireland - Industry Partners





Intergroup Collaborations – Issues/ Challenges

Insurance / Indemnity:

Study Insurance policy from study Sponsor:

• limit of indemnity must be 6.5m Euro for Ireland

• jurisdiction must cover Ireland

Clinical Trial indemnity form to be signed by study Sponsor

Study finance:

• Group local management & monitoring responsibilities

• Group pharmacovigilance responsibilities

• Regulatory / EC (pass through costs)

• Site investigator fee payments

20 Confidential – Cancer Trials Ireland use only




Cancer Trials Ireland 60 Fitzwilliam Square, Dublin 2, Ireland Tel: +353 1 6677211 Fax: +353 1 6697869 Kathleen Scott, Clinical Program Leader Email: [email protected] Eibhlin Mulroe, CEO Email: [email protected]

Thank you

Cancer Trials Ireland Central Office - contact details:



mailto:[email protected]

mailto:[email protected]

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