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European Paediatric Oncology Off-Patent Medicines Consortium

Objective

Cancer chemotherapy has a key role in the successful treatment of a number of childhood cancers. Nevertheless, at least 20% of patients are not cured by current therapies and a significant number experience debilitating toxicities. Given the high cure rates and potential life-span of survivors of childhood cancer, it is particularly important to minimize the impact of potential chronic toxicities. For several of the most widely-used drugs, little is known about their pharmacokinetics and metabolism in children, particularly very young children (<3 years). There are many examples where such knowledge has been used to optimize the use of chemotherapeutic drugs, both to avoid toxicity and to maximize the therapeutic effect. The need for further research to investigate these drugs in children is acknowledged in the Priority List for Studies into Paediatric Medicinal Products, issued by the EMEA. Doxorubicin is on this list and is one of the most important drugs used in the treatment of childhood cancers. Several national groups have been successful in studying the pharmacology of drugs used in paediatric oncology. However, in order to recruit sufficient patient numbers for meaningful studies it is necessary to establish a wider group, bringing together the successful elements of established national organizations. The EPOC group combines leading pharmacologists, paediatric oncologists, regulatory organizations and a management structure which will successfully deliver data of appropriate quality on which to base future clinical use of this drug and to meet the demands of the EMEA priority list. Such data will form the basis of future applications for Paediatric Usage Marketing Authorization for doxorubicin. The overall aim of the consortium is to provide data that will guide the optimal use of this drug in the clinic, and also meet the regulatory requirements of the EMA.

Call for proposal

FP7-HEALTH-2007-B
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Coordinator

UNIVERSITY OF NEWCASTLE UPON TYNE
Address
Kings Gate
NE1 7RU Newcastle Upon Tyne
United Kingdom

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Nicola Place (Ms.)
EU contribution
€ 379 683,86

Participants (10)

THE INSTITUTE OF CANCER RESEARCH: ROYAL CANCER HOSPITAL

Participation ended

United Kingdom
Address
Old Brompton Road 123
SW7 3RP London

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Yodry Vasquez (Mr.)
UNIVERSITY OF LEICESTER

Participation ended

United Kingdom
Address
University Road
LE1 7RH Leicester

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Marie Singer (Ms.)
CANCER RESEARCH UK LBG
United Kingdom
EU contribution
€ 75 750
Address
St John Street 407 Angel Building
EC1V 4AD London

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Activity type
Research Organisations
Administrative Contact
Robina Ibanda (Ms.)
POWERTRIAL LIMITED
United Kingdom
EU contribution
€ 84 200
Address
Marquis Court Unit A2 Team
NE11 0RU Newcastle

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Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Rachael Hogg (Ms.)
Westfälische Wilhelms-Universität Münster
Germany
EU contribution
€ 900 467
Address
Schlossplatz 2
48149 Muenster

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Carola Brieger (Dr.)
ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI
Italy
EU contribution
€ 194 541,14
Address
Via Mario Negri 2
20156 Milano

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Activity type
Research Organisations
Administrative Contact
Maurizio D'incalci (Dr.)
AZIENDA OSPEDALE UNIVERSITA PADOVA
Italy
EU contribution
€ 71 649
Address
Via Nicolo Giustiniani 1
35128 Padova

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Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Administrative Contact
Antonio Giona (Dr.)
CONFEDERACION INTERNACIONAL DE ORGANIZACIONES DE PADRES DE NINOS CON CANCER ASOCIACION
Spain
EU contribution
€ 50 000
Address
Plaza Pablo Picasso 9 3 D
46015 Valencia

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Activity type
Other
Administrative Contact
Marianne Naafs-Wilstra (Dr.)
UCL Elizabeth Garrett Anderson Institute for Women’s Health
United Kingdom
EU contribution
€ 52 999
Address
Gower Street
WC1E 6BT London

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Greta Borg-Carbott (Ms.)
UNIVERSITE D'AIX MARSEILLE
France
EU contribution
€ 188 572
Address
Boulevard Charles Livon 58 Le Pharo
13284 Marseille

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Celine Damon (Ms.)