Spots Global Cancer Trial Database for GANNET53: Ganetespib in Metastatic, p53-mutant, Platinum-resistant Ovarian Cancer
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Trial Identification
Brief Title: GANNET53: Ganetespib in Metastatic, p53-mutant, Platinum-resistant Ovarian Cancer
Official Title: A Two-part, Multicentre, International Phase I and II Trial Assessing the Safety and Efficacy of the Hsp90 Inhibitor Ganetespib in Combination With Paclitaxel Weekly in Women With High-grade Serous, High-grade Endometrioid, or Undifferentiated, Platinum-resistant Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer
Study ID: NCT02012192
Study Description
Brief Summary: Epithelial ovarian cancer (EOC) is the most lethal gynaecological malignancy causing 41900 deaths annually in Europe. The predominance of aggressive Type II tumours, which are characterised by a high frequency of p53 mutations, and primary or acquired resistance to platinum-based chemotherapy profoundly contribute to the high mortality rate. With current standard therapy the median overall survival of metastatic platinum-resistant (Pt-R) ovarian cancer patients is only 14 month. There is a pressing need for more effective, innovative treatment strategies to particularly improve survival in this subgroup of EOC patients. This is a drug strategy targeting a central driver of tumour aggressiveness and metastatic ability, namely mutant p53, via an innovative new Hsp90 (heat shock protein 90) inhibition mechanism. The most advanced, second-generation Hsp90 inhibitor will be used, Ganetespib. The first part (Phase I) of the GANNET53 trial will test the safety of Ganetespib in a new combination with standard chemotherapy (Paclitaxel weekly) in Pt-R EOC patients. The second part (randomised Phase II) will examine the efficacy of Ganetespib in combination with standard chemotherapy versus standard chemotherapy alone in EOC patients with Pt-R tumours.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Medical University Innsbruck, Department for Gynaecology and Obstetrics, Innsbruck, , Austria
Katholieke Universiteit Leuven, Dept. of Gynaecologic Oncology, Leuven, , Belgium
Centre de lutte contre le cancer Francois Baclesse, Caen, , France
Centre Anticancereux Léon Bérard, Lyon, , France
Assistance Publique - Hôpitaux de Paris Medical Oncology Department, Paris, , France
Universitätsmedizin Berlin Charité, Dept. for Gynecology, Berlin, , Germany
University Hospital Carl Gustav Carus Dresden, Department of Gynaecology and Obstetrics, Dresden, , Germany
Kliniken Essen Mitte, Evang. Huyssens-Stiftung / Knappschaft GmbH Department of Gynaecologic Oncology, Essen, , Germany
Universitätsklinikum Hamburg-Eppendorf Dept. of Gynecology and Gynecologic Oncology, Hamburg, , Germany
Otto-von-Guericke-Universität Magdeburg, Magdeburg, , Germany
Contact Details
Name: Nicole Concin, MD
Affiliation: Medical University Innsbruck
Role: PRINCIPAL_INVESTIGATOR
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