Project Partners No. 1-18


Medizinische Universität Innsbruck – Austria (P1 and Coordinator)

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Katholieke Universiteit Leuven – Belgium (P2)

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Charité - Universitätsmedizin Berlin – Germany (P3)

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Universitätsklinikum Hamburg-Eppendorf – Germany (P4)

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Medizinische Universität Wien – Austria (P5)

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Assistance Publique - Hôpitaux de Paris – France (P6)

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Centre Anticancereux Léon Bérard, Lyon – France (P7)

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AGO Research GmbH – Germany (P8)

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Nord-Ostdeutsche Gesellschaft für Gynäkologische Onkologie - Germany (P9)

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Association de Recherche dans le Cancers dont Gynécologique – Groupe des Investigateurs Nationaux dans l’Etude des Cancers Ovariens (ARCAGY-GINECO), Paris, France (P10)

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Universitätsmedizin Goettingen – Germany (P11)

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OncoLab Diagnostics GmbH – Austria (P12)

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xailabs GmbH – Germany (P13)

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Klinik Essen-Mitte, Evang. Huyssens-Stiftung/ Knappschaft gemeinnützige GmbH – Germany (P14)

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Technische Universität Dresden University Hospital Carl Gustav Carus Dresden - Germany (P15)

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Centre de lutte contre le cancer, Francois Baclesse, Caen CFB France (P16)

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Ernst-Moritz-Arndt-Universität Greifswald – Germany (P17)

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Otto-von-Guericke-Universität Magdeburg – Germany (P18)

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Work Packages (WP)

In order to achieve the objectives of this project, the GANNET53 trial is structured into eight work packages (WP):

WP1 is responsible for all management activities.

WP2 will organise all legal, ethical, and administrative prerequisites necessary for Phase I and Phase II clinical trials.

WP3 and WP4 execute the centrepieces of the GANNET53 project, i.e. Phase I and Phase II clinical trial, respectively. WP3 is a Phase I dose escalation/de-escalation study aiming to define the safety of the experimental drug Ganetespib given in a new combination with Paclitaxel in high-grade serous, high-grade endometrioid or undifferenciated, platinum-resistant ovarian cancer patients. WP3 will provide the Ganetespib combination dose to be used in the Phase II trial.

WP4 is a randomised two-arm open label Phase II trial in which the efficacy of Ganetespib in combination with Paclitaxel versus Paclitaxel alone will be determined in 222 high-grade serous, high-grade endometrioid or undifferenciated, platinum-resistant ovarian cancer patients. It will also include the collection of biomaterials.

WP5 will organise the retrospective (archival) and prospective collection, handling, processing and barcoded storage of biomaterials by developing SOPs. Moreover, WP5 provides central histopathological review (CHR) of archival ovarian cancer tissues at primary diagnosis in all Phase II patients. Only patients with tumours of eligible histological subtypes will be included into the Phase II trial. CHR will also provide the quality control of all biosamples to be used in experimental work. Another core task of WP5 is the development of three dedicated data handling systems, ie two web-based systems for the documentation of clinical data in Phase I and Phase II (eCRFs), respectively, and a third system providing a virtual biobank and enabling tracking of biosamples.

WP6's core task is the exact determination of p53 mutational status in all Phase II patients in archival and prospectively collected biosamples. WP6 includes the processing of collected biomaterials by patient-recruiting centres. WP6 will perform molecular efficacy testing of Ganetespib in collected biomaterials and correlate findings with clinical outcome.

WP7 will lift the underlying scientific concept of the clinical trials to the highest level of preclinical evidence by genetic and pharmacologic proof-of-principle experiments in vivo in engineered mice and human xenografts. Furthermore, this WP will perform a stringent causality proof for Ganetespib-mediated drug action leading to preferential killing of mutp53 cancer cells in human ovarian cancer models using cell cultures and Xenografts.

WP8 is dedicated to dissemination.