The GANNET53 consortium consists of 22 partners from 5 European countries (Austria, Belgium, France, Germany and Italy). We are a group of passionate collaborates and an interdisciplineary team that has one common goal: improve the life of patients suffering from ovarian cancer.

The GANNET53 consortium consists of

• 14 patient-recruiting clinical centres
• 4 so-called national trial groups
• 1 coordinating centre for clinical trials
• 3 research organisations involved in translational research
• 1 software and database company with focus on medical IT solutions

Detailed description of all GANNET53 Project Partners

The project coordinator is the intermediary for the communication between European Commission and the participants. The project management team (PMT) includes the project coordinator, a medical clinical trial manager, the clinical trial administrator (AAGO trial centre: legal sponsor) and an administrative manager. The PMT takes the responsibility of day-to-day management of the project. There are 22 participants in the GANNET53 consortium; each contributes to various tasks defined in eight work packages (WP). Each work package is led by a work package leader (WP leader). The two core work packages, WP3 (Phase I) and WP4 (Phase II), respectively, are organised with an additional management layer between participant and WP leader, namely the national trial groups. The WP leaders, the national trial group leaders and the PMT make up the Managerial Board (MB). A Steering Committee (SC) includes all participants in the consortium (except for the national trial groups; see below) and is the decision-making organ of the project. In addition, an External Advisory Board (EAB) is established including five eminent experts from different areas relevant to the project. For clinical trial safety monitoring a Data and Safety Monitoring Committee (DSMC) is established.

The Coordinator (Nicole Concin) is the intermediary for the communication between the European Commission and the contractors. In this function the coordinator may be considered the “head of the project” and is responsible for the overall scientific, financial, gender and ethical coordination of the project and for being carried out in a timely manner.

Profile Nicole Concin

Nicole Concin (P1)

Nicole Concin, MD, PhD, is gynaecological oncologist and professor for experimental gynaecology at the Medical University of Innsbruck. She is president elect of the ESGO (European Society of Gynaecological Oncology) and Co-Chair of ENGOT (European Network of Gynaecological Oncological Trial Groups) Early Drug Development Network.

The Project Management Team, the Work Package (WP) Leaders, and the National Trial Group Leaders make up the MB. The MB is responsible for monitoring the project progress towards the objectives (deliverables, milestones), ensuring collaboration within and between the WP, coordinating future activities and decision-making/problem-solving in case of unforeseen difficulties. The MB will in particular monitor the strategy for use and dissemination of the project results. The MB will generally decide by majority vote. The MB will get advice from the External Advisory Board (EAB).

As suitable for the complexity and scale of the project, the project management will be performed by a team. The project management team (PMT) is responsible for the day-to-day scientific, ethical, gender, financial, administrative, and contractual management of the project. The PMT consists of the Coordinator, the Project Manager, the Medical Clinical Trial Manager and the Clinical Trial Administrator (Austrian-AGO trial centre at Innsbruck Medical University: legal sponsor of the GANNET53 trial; BOGO at KU Leuven, Belgium: legal sponsor of the EUDARIO trial).

The Project Manager (Gabriele Klaming) is responsible for the overall administrative management of the project. She is responsible for all organisational task regarding EU requirements.

Profile Gabriele Klaming

Gabriele Klaming (P12)

Gabriele Klaming, MA, COO of OncoLab, is an experienced manager for multinational projects; she has worked as a legal translator and knowledge manager and has extensive experience in administration and organization;

The Medical Clinical Trial Manager (Alain Zeimet) is responsible for the executive medical management of the clinical trials.

Profile Alain Zeimet

Alain Zeimet (P1)

Alain G. Zeimet, MD, PhD, is the past president of the Austrian-AGO and leads the gynaecologic oncology group at the Department of Obstetrics and Gynaecology at Innsbruck Medical University.

The Clinical Trial Administrator (Regina Berger) is responsible for the overall administrative clinical trial coordination.

Clinical Trial Administrator in the GANNET53 trial:

Profile Regina Berger

Regina Berger

Regina Berger, PhD, Head of A-AGO trial centre: PhD in molecular biology; Post-Doc/Scientist in several preclinical studies.

Clinical Trial Administrator in the EUDARIO trial:

Profile Joke De Roover

Joke De Roover

Joke De Roover, PhD, Head of Clinical Trial Unit Gynaecologic Oncology at UZ Leuven, BGOG

The two core work packages, i.e. WP3 and WP4 (Phase I and II clinical trials), are organised with an additional management layer between participants, i.e. patient-recruiting centre, and WP leader, namely the national trial groups. National trial groups are responsible for the administrative coordination of the clinical trial on the level of their assigned national centres.

National Trial Group Leaders:

Profile Christian Marth

Christian Marth (P1)

Christian Marth, MD, PhD, President of Austrian-AGO: Principal Investigator of >40 clinical Phase II and III trials; Council member of the European Society of Gynaecological Oncology (ESGO) and member of the board of directors of the Gynaecological Cancer Intergroup (GCIG); Since 6 years Chair of the ovarian cancer committee of the GCIG; Reviewer of several scientific journals; Lead Investigator/Austrian-AGO lead-trial group for multinational, multicentre Trinova 2 study.

Profile Eric Pujade-Lauraine

Eric Pujade-Lauraine (P 6)

Eric Pujade-Lauraine, MD, PhDis the founder of GINECO and current Chair of GCIG (Gynaecological Cancer Intergroup), which is the umbrella under which all cooperative groups focusing on gynaecological cancer world-wide are organised. He is also member of the board of the ENGOT (European Network of Gynaecology Oncology Trial), member of the American NCI Gynaecological Cancer Steering Committee, and the Chair of the AP-HP National Rare Gynaecological Tumour Reference Centre of AP-HP. He has authored more than 130 original full papers in peer-reviewed journals.

Profile Ignace Vergote

Ignace Vergote (P2)

Ignace Vergote, MD, PhD, is the Chair of the Protocol Committee of the European Organisation for Research and Treatment of Cancer - Gynaecological Cancer Group (EORTC-GCG), the Past-Chairman of the European Network of Gynaecological Oncological Trial groups (ENGOT), the Chairman of the Leuven Cancer Institute, and is Past-President of the European Society of Gynaecological Oncology (ESGO) and the International Gynaecologic Cancer Society (IGCS). He has authored more than 590 original full papers in peer-reviewed journals, 50 book chapters, and edited several books on Gynaecological Oncology. He is also the Editor of the European Journal of Cancer – Gynaecological Cancer and member of the Editorial Board of numerous medical journals such as the Journal of Clinical Oncology, Gynaecologic Oncology and the Int. J. Gynaecologic Cancer.

Profile Jalid Sehouli

Jalid Sehouli (P 9)

Jalid Sehouli, MD, PhD, has extensive clinical expertise in gynaecological oncology, especially in ovarian cancer, and is the initiator and leader of many clinical trials. He published more than 230 peer-reviewed articles. Professor Sehouli is a member in NOGGO and in other national and international study groups. His contributions to the field of ovarian cancer have been exceptional. He will lead NOGGO in the GANNET53 project.

Profile Sven Mahner

Sven Mahner (P8)

Sven Mahner, MD, has long-standing expertise in clinical phase I/II and III trials in ovarian cancer and in translational research. He is a member of the steering committee and executive board of the AGO-OVAR study group and represents this group in the Gynaecologic Cancer Intergroup (GCIG). He has authored more than 60 original full papers in peer-reviewed journals and several book chapters on Gynaecologic Oncology and received numerous awards for his research.

Profile Domenica Lorusso

Domenica Lorusso (P21)

Domenica Lorusso, MD, PhD, is responsible of Gynaecological Medical Treatment Unit at National Cancer Institute of Milan. She has been involved in Gynaecologic Oncology research and in designing and conducting clinical trials for more than 15 years and, as sub-investigator at the beginning and principal investigator later, she participated to more than 80 clinical trials in gynaecological cancers. Dr Lorusso is responsible of the Clinical Trials Committee of the MITO Group (Multicentre Italian Trials in Ovarian Cancer and Gynaecological Malignancies) grouping more than 150 Italian centres committed in gynaecology oncology research. She is also member of the board of Directors of the Gynaecological Cancer Intergroup (GCIG), formed by 23 international research groups all over the world, which aims to promote and conduct high quality clinical trials to improve outcome for women with gynaecological cancers. Dr Lorusso is also active member of ENGOT (European Network of Gynaecological Oncological Trial groups) an international organization supported by and part of the European Society of Gynaecological Oncology (ESGO) which coordinates and promotes clinical trials within Europe on patients with gynaecological cancer. She is also member of ESMO (European Society of Medical oncology). She is considered opinion leader in the field of gynaecological cancer in Italy and abroad.

The Steering Committee (SC) is the decision-making organ of the GANNET53 consortium and will decide all issues not covered by the consortium agreement. To ensure a fair cooperation of all participants, this board follows the matrix organisation structure: members responsible for specific tasks only report and advice, the group leaders of the consortium have voting power (including the coordinator), but have decision power only as a whole body. The SC will meet at least once a year to monitor the progress and will get advice form the External Advisory Board (EAB).

The Trial Statistican (Hanno Ulmer) is responsible for all statistical issues of the clinical trial.

Profile Hanno Ulmer

Hanno Ulmer (P1)

Hanno Ulmer, PhD is the director of the Department of Medical Statistics, Informatics and Health Economics of P1 and is responsible for all statistical issues of the GANNETp53 trial. He was fundamentally involved in the trial design of this project and performed as well the sample size calculation for Phase II. He is currently the president of the Austro-Swiss Region of the International Biometrical Society and has 20 years of experience in clinical research with more than 350 published articles. He has been the responsible statistician in more than 200 clinical studies, many of which in the field of oncology.

In order to strengthen the power of the consortium, to update the plans according to 1) developments and changes in clinical, scientific and technologically relevant areas, and to 2) significant changes or problems arising within the consortium, we will establish an EAB with four members, whose world renowned expertise cover very important areas relevant to the GANNET53 trial. EAB will advise the MB and the SC. At least the EAB chair will be invited to all meetings of the SC.

Members

Sir David Lane	Sir David Lane, PhD, co-discovered p53 in 1979 and can be considered the father of p53. Due to his discovery he was the most quoted scientist in life sciences (> 19,0000 citations per year) in the 1990s and was given KNITGHT status “Sir” by the English Queen in 2000. He was appointed by Singapore government to take on as Director General of the new Singapore's Biomedical Initiative and as well holds a concurrent appointment as the Chief Scientist with Cancer Research, UK.
Reinhard Merkel	Reinhard Merkel, PhD, is professor of legal philosophy and criminal law at the University of Hamburg, Germany, and member of the German Ethics Board (Deutscher Ethikrat; http://www.ethikrat.org/).
Alison O'Neill	Alison O’Neill, M.D.,, is Vice President of Clinical Research at Synta Pharmaceuticals, the company developing the lead Hsp90 inhibitor Ganetespib. She is a neuro-oncologist and has extensive experience in oncology drug development, leading clinical research programs within academia and more recently within the pharmaceutical industry.
Nicoletta Cerana	Nicoletta Cerana , is President of Acto Onlus(Alleanza Contro il Tumore Ovarico) (www.actoonlus.it), an Italian charity-based ovarian cancer advocacy group in Milan. It was founded in 2010 by a group of patients and clinicians with the aim to a) raise awareness and promote education about ovarian cancer, b) improve the survival rate and quality of life of women with ovarian cancer, c) provide support to women affected by the disease.

The Independent Data Monitoring Committee (IDMC) will be responsible for independently evaluating the safety of the patients participating in the trial. All captured adverse events and safety reports will be reported to the DSMC for assessment. The IDMC will meet (e.g. via teleconference) on a regular basis over the course of the study and may also meet on an unscheduled basis if any unexpected safety concerns arise.

Members

Stan Kaye

Stan Kaye, MD, PhD, of Royal Marsden Hospital, London, UK, was until recently the Head of the Division of Clinical Studies at the Institute of Cancer Research London, and Head of the Drug Development Unit at Royal Marsden Hospital, one of the largest Phase I trials units in the world. He has long experience in leading on clinical trials in cancer and has most recently been involved in the development of PARP inhibitors. The author of over 400 peer reviewed papers, he sits on the editorial board of 12 cancer journals, and over the past 20 years has chaired national and international committees within EORTC (European Organisation for Research and Treatment of Cancer) MRC (Medical Research Council, UK) and CRUK (Cancer Research UK).

Mark F. Brady

Mark F. Brady, PhD, is a statistician of the Gynaecologic Oncology Group (GOG) of the United States heading the GOG Statistical and Data Centre in Buffalo, New York, USA. He is the leading expert in statistical analysis of gynaecologic oncological trials.

Sandro Pignata

Sandro Pignata, MD, PhD of the Instituto Nazionale Tumouri, Napoli, Italy, is a gynaecologic oncologists and leading experts in ovarian cancer. He is involved in the Gynaecological Cancer Intergroup (GCIG) and represent the national gynaecologic-oncology groups with an outstanding experience in performing and designing clinical trials in ovarian cancer.

Ana Oaknin

Ana Oaknin, MD, PhD, (Hospital Vall d’Hebron, Barcelona, Spain) is a gynaecologic oncologists and a leading experts in ovarian cancer. She is involved in the Gynaecological Cancer Intergroup (GCIG) and represent the national gynaecologic-oncology groups with an outstanding experience in performing and designing clinical trials in ovarian cancer.

Christina Sessa

Cristiana Sessa, MD has been working at the Oncology Institute of Southern Switzerland, Ospedale San Giovanni, Bellinzona since 1981 as Head of Phase I-II Unit and Pharmacology and is currently Vice Head of Medical Oncology and Head of Clinical Research. She has been Administrative Director of the Clinical Trial Unit of the Ente Ospedaliero Cantonale (CTU-EOC) since 2012. Since 2014, she has been a member of the Scientific Board of the Swiss Group for Clinical Cancer Research (SAKK). Cristiana Sessa is a member of the European Society for Medical Oncology (ESMO), where she is Co-chair of the ESMO Guidelines Committee and a member of the Translational Research Working Group.Cristiana Sessa was appointed to the Executive Board of the European Society of Gynecologic Oncology (ESGO) in 2013.

Selbsthilfegruppe für Frauen mit Unterleibskrebs, Linz

Contact

Esther Sandrieser

Mag. Esther Sandrieser, Phone: +43 (0)664 9915077, Email: info@unterleibskrebs.at

Selbsthilfegruppe Eierstock- und Gebärmutterkrebs; Berlin

Contact

Rosemarie Mittermair

Rosemarie Mittermair, Phone: +49 (0)30-85 99 51 30, Web: www.eierstockkrebs-selbsthilfegruppe.de

Selbsthilfegruppe Ovarialkazinom OVARCOME, Wien

Contact

Marianne Kohn	Marianne Kohn, Web: http://www.ovarcome.at/, Email: kontakt@ovarcome.at
Margit Wild	Mag. Margit Wild, Web: http://www.ovarcome.at/, Email: kontakt@ovarcome.at

Deutsche Stiftung Eierstockkrebs, Berlin

Contact

Dr. Ioana Braicu

Ioana Braicu, Web: http://www.stiftungeierstockkrebs.de/, Email: stiftung.eierstockkrebs@gmail.com

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

WP1 comprises all management activities in connection with the EU FP7 project.

WP2 organisse all legal, ethical, and administrative prerequisites necessary for Phase I and Phase II clinical trials, i.e the GANNET53 and the EUDARIO trials.

WP3 and WP4 are the centrepieces of the GANNET53 project, i.e. Phase I and Phase II clinical trials based on the use of the HSP90 inhibitor Ganetespib, respectively. WP3 is the Phase I GANNET53 dose escalation/de-escalation study aiming to define the safety of the experimental drug Ganetespib given in a new combination with Paclitaxel in Pt-R ovarian cancer patients with Type II tumours. WP3 will provide the Ganetespib combination dose to be used in the Phase II GANNET53 trial (takes 10 months: M9-18).

WP4 comprises two randomised, open label, Ganetespib-based Phase II trials (begins 1.5 years after project start), in which the efficacy of Ganetespib combinations versus standard chemotherapy will be determined in 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 in all Phase II patients. 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 four dedicated data handling systems, i.e. three web-based systems for the documentation of clinical data (eCRFs) in Phase I and Phase II GANNET53 trial and in the EUDARIO trial, respectively, and a fourth system providing a virtual biobank and enabling tracking of biosamples.

The core task in WP6 is the exact determination of p53 mutational status in all Phase II GANNET53 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 in the GANNET53 and EUDARIO trials, e.g. a functional molecular test to predict responsiveness to Ganetespib will be developed and evaluated.

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.

To ensure clear responsibilities and smooth decision making, the next layer in the management structure has the classical line-and-staff structure: Each WP has a WP leader who is responsible for the timely implementation of the work plan, for continuously monitoring and reporting progress, for identifying the needs for Intellectual Property (IP) management at the WP level.

Work Package Leaders:

Profile Nicole Concin (WP 1 & 8)

Nicole Concin (P1)

Nicole Concin, MD, is a gynaecologist with a clinical focus on Gynaecological Oncology and Professor of Experimental Gynaecology. She is a renowned physician-scientist in p53 translational research in ovarian cancer. Her research group focuses on the clinical relevance of p53 family members (p53/p73 and isoforms) in ovarian cancer and continuously publishes on this topic in high-ranked peer-reviewed jounals since 10 years. She is a member of the scientific board of Austrian-AGO and Tumorbank Ovarian Cancer Network (TOC). the Leader of WP 1 (Management) and WP 8 (Dissemination)

Profile Regina Berger (WP 2)

Regina Berger (P1)

Regina Berger, PhD, Head of Austrian-AGO trial centre: PhD in molecular biology; Post-Doc/Scientist in several preclinical studies.WP2: preparations for clinical trials

Profile Isabelle Ray-Coquard (WP 3)

Isabelle Ray-Coquard (P7)

Isabelle Ray-Coquard, MD, PhD, is the Past Chair of the GINECO, the current Chairman of the rare-tumour working group of GCIG, the Chairman of the multidisciplinary staff dedicated to gynaecologic cancer (CLB) and the national co-coordinator of the rare ovarian cancer network supported by the InCA (French NCI). She has authored more than 200 original full papers in peerreviewed journals, 10 book chapters, and edited several books on Gynaecological Oncology.WP3: clinical trial Phase I

Profile Ignace Vergote (WP 4)

Ignace Vergote (P2)

Ignace Vergote, MD, PhD, is the Chair of the Protocol Committee of the European Organisation for Research and Treatment of Cancer - Gynaecological Cancer Group (EORTC-GCG), the Past-Chairman of the European Network of Gynaecological Oncological Trial groups (ENGOT), the Chairman of the Leuven Cancer Institute, and is Past-President of the European Society of Gynaecological Oncology (ESGO) and the International Gynaecologic Cancer Society (IGCS). He has authored more than 590 original full papers in peer-reviewed journals, 50 book chapters, and edited several books on Gynaecological Oncology. He is also the Editor of the European Journal of Cancer – Gynaecological Cancer and member of the Editorial Board of numerous medical journals such as the Journal of Clinical Oncology, Gynaecologic Oncology and the Int. J. Gynaecologic Cancer.WP4: clinical trial phase II

Profile Ioana Braicu (WP 5)

Ioana Braicu (P3)

Elena Ioana Braicu, MD, is a physician working in the field of ovarian cancer. She is leading the Tumorbank Ovarian Cancer Network (TOC) Laboratory and the translational research within the group. She is also involved in two other European Union research projects (OVCAD and OCTIPS).WP5: central histopathological review, biobanking and data repository

Profile Robert Zeillinger (WP 6)

Robert Zeillinger (P12)

Robert Zeillinger, PhD, founder and CEO of OncoLab, is leader of the Molecular Oncology Group at Medical University of Vienna; he has 25 years of experience in the field of molecular oncology, experimental oncology, gynaecologic oncology, and was initiator and coordinator of the EU FP6 project OVCAD. He is author and co-author of more than 180 scientific publications and holds several patents.WP6: companion diagnostics

Profile Ute Moll (WP 7)

Ute Moll (P11)

Ute Moll, MD, PhD is a world-renowned p53 researcher at Göttingen University. Her research focus is on function and regulation of the p53/p63/p73 family of tumour suppressors. She is also a board-certified anatomic and clinical pathologist, and her work has a strong translational direction. Since 20 years she is the Principal Investigator of a continuously productive, well-funded research laboratory. Her research includes multiple successfully completed projects with uninterrupted grant support from the US National Cancer Institute, New York State Health Research Board, Deutsche Forschungsgemeinschaft and Krebshilfe, among others. She lectured and trained > 40 students and postdocs (eg Nicole Concin trained as postdoctoral fellow with Ute Moll) and authored over 138 peer-reviewed high impact papers in cancer including ovarian cancer (cited 7,520 times with an hindex of 43 and a combined Total Impact Factor of 769). She regularly gives invited lectures at international meetings and often serves as co-organizer of international meetings. WP7: mouse models and human Xenografts