Spots Global Cancer Trial Database for Pertuzumab in Platinum-Resistant Low Human Epidermal Growth Factor Receptor 3 (HER3) Messenger Ribonucleic Acid (mRNA) Epithelial Ovarian Cancer (PENELOPE)
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Trial Identification
Brief Title: Pertuzumab in Platinum-Resistant Low Human Epidermal Growth Factor Receptor 3 (HER3) Messenger Ribonucleic Acid (mRNA) Epithelial Ovarian Cancer (PENELOPE)
Official Title: A Two-Part, Randomized Phase III, Double-Blind, Multicenter Trial Assessing The Efficacy And Safety of Pertuzumab In Combination With Standard Chemotherapy Vs. Placebo Plus Standard Chemotherapy In Women With Recurrent Platinum-Resistant Epithelial Ovarian Cancer And Low HER3 mRNA Expression
Study ID: NCT01684878
Conditions
Study Description
Brief Summary: This two-part, multicenter study will evaluate the safety, tolerability and efficacy of pertuzumab in combination with standard chemotherapy in women with recurrent platinum-resistant epithelial ovarian cancer. In the non-randomized Part 1 safety run-in, participants will receive pertuzumab plus either topotecan or paclitaxel. In the randomized, double-blind Part 2 of the study, participants will receive either pertuzumab or placebo in combination with chemotherapy (topotecan, paclitaxel, or gemcitabine).
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Tiroler Landeskrankenanstalten Ges.M.B.H.; Abt. Für Gynäkologie, Innsbruck, , Austria
Medizinische Universität Wien; Univ.Klinik für Frauenheilkunde - Klinik für Gynäkologie, Wien, , Austria
UZ Leuven Gasthuisberg, Leuven, , Belgium
Herlev Hospital; Onkologisk afdeling, Herlev, , Denmark
Rigshospitalet, Onkologisk Klinik, København Ø, , Denmark
Institut Bergonie; Oncologie, Bordeaux, , France
Centre Francois Baclesse; Oncologie, Caen, , France
Centre Georges Francois Leclerc; Oncologie 3, Dijon, , France
CRLCC Val dAurelle Paul Lam, Montpellier cedex 5, , France
Hopital Tenon; Oncologie Radiotherapie, Paris, , France
Ch Lyon Sud; Chir Onc Gyne Sct Jules Courmont, Pierre Benite, , France
Clinique Armoricaine Radiologie; Hopital de Jour, Plerin, , France
Ico Rene Gauducheau; Oncologie, Saint Herblain, , France
Centre Alexis Vautrin; Oncologie Medicale, Vandoeuvre Les Nancy, , France
Institut Gustave Roussy; Oncologie Medicale, Villejuif, , France
Universitätsklinikum "Carl Gustav Carus"; Frauenheilkunde und Geburtshilfe, Dresden, , Germany
Evangelischen Krankenhauses Düsseldorf; Frauenklinik, Düsseldorf, , Germany
Universitätsklinikum Essen; Zentrum Für Frauenheilkunde, Essen, , Germany
Kliniken Essen-Mitte Evang. Huyssens-Stiftung, Klinik für Gynäkologie und gynäkologische Onkologie, Essen, , Germany
Universitätsklinikum Freiburg; Frauenklinik, Freiburg, , Germany
Universitätsklinikum Greifswald; Klinik für Frauenheilkunde und Brustzentrum, Greifswald, , Germany
Universitätsklinikum Hamburg-Eppendorf (UKE); Klinik und Poliklinik für Gynäkologie, Hamburg, , Germany
Gynaekologisch-Onkologische Schwerpunktpraxis Prof. Dr. med. Lueck, Dr. Schrader und Dr. Noeding, Hannover, , Germany
Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg, Heidelberg, , Germany
UNI-Klinikum Campus Kiel Klinik f.Gynäkologie u.Geburtshilfe, Kiel, , Germany
St. Elisabeth Krankenhaus Köln GmbH; Gynäkologie und Geburtshilfe, Koeln, , Germany
Klinikum Konstanz, Frauenklinik, Konstanz, , Germany
Klinikum rechts der Isar der TU München; Frauenklinik & Poliklinik, München, , Germany
Sana Klinikum Offenbach GmbH; Klinik für Gynäkologie & Geburtshilfe, Offenbach, , Germany
Hämatologisch/Onkologische Praxis Dr. Herbrick - Zipp/Prof. Dr. Decker, Studienzentrum, Ravensburg, , Germany
Universitätsfrauen- und Poliklinik am Klinikum Suedstadt, Rostock, , Germany
Universitätsklinik Tübingen; Frauenklinik, Tübingen, , Germany
Universitätsklinikum Ulm Am Michelsberg; Frauenklinik, Ulm, , Germany
HELIOS Dr. Horst Schmidt Kliniken Wiesbaden; Klinik für Gynäkologie und gynäkologische Onkologie, Wiesbaden, , Germany
Istituto Tumori Napoli;Unità Operativa Oncologia Medica Uro-Ginecologica, Napoli, Campania, Italy
Istituto Regina Elena; Oncologia Medica A, Roma, Lazio, Italy
Ente Ospedaliero Ospedali Galliera; S.C. Oncologia Medica, Genova, Liguria, Italy
A.O.Spedali Civili; Ostetricia e Ginecologia, Brescia, Lombardia, Italy
Istituto Nazionale dei Tumori; Divisione Oncologia Chirurgica e Ginecologica, Milano, Lombardia, Italy
Istituto Europeo Di Oncologia, Milano, Lombardia, Italy
A.O.U Pisana; Dipartimento di Ginecologia Oncologica, Pisa, Toscana, Italy
Antoni van Leeuwenhoek Ziekenhuis, Amsterdam, , Netherlands
Academ Ziekenhuis Groningen; Medical Oncology, Groningen, , Netherlands
Academisch Ziekenhuis Leiden; Clinical Oncology, Leiden, , Netherlands
UMC St Radboud, Nijmegen, , Netherlands
The Norvegian Radium Hospital Montebello; Dept of Oncology, Oslo, , Norway
Corporacio Sanitaria Parc Tauli; Servicio de Oncologia, Sabadell, Barcelona, Spain
Hospital Son Llatzer; Servicio de Oncologia, Palma de Mallorca, Islas Baleares, Spain
Hospital Univ Vall d'Hebron; Servicio de Oncologia, Barcelona, , Spain
Hospital Clínic i Provincial; Servicio de Hematología y Oncología, Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia, Barcelona, , Spain
Hospital Duran i Reynals; Oncologia, Barcelona, , Spain
Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia, Barcelona, , Spain
Hospital Universitario Reina Sofia; Servicio de Oncologia, Cordoba, , Spain
Hospital Universitari de Girona Dr. Josep Trueta; Servicio de Oncologia, Girona, , Spain
Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Oncologia, Lerida, , Spain
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia, Madrid, , Spain
Centro Oncologico MD Anderson Internacional; Servicio de Oncologia, Madrid, , Spain
Hospital Universitario 12 de Octubre; Servicio de Oncologia, Madrid, , Spain
Hospital Universitario La Paz; Servicio de Oncologia, Madrid, , Spain
Centro Integral Oncologico Clara Campal (CIOCC); Dirección Médica, Madrid, , Spain
Hospital Regional Universitario Carlos Haya; Servicio de Oncologia, Malaga, , Spain
Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia, Murcia, , Spain
Instituto Valenciano Oncologia; Oncologia Medica, Valencia, , Spain
Hospital Universitario la Fe; Servicio de Oncologia, Valencia, , Spain
Hospital Universitario Miguel Servet; Servicio Oncologia, Zaragoza, , Spain
Universitetssjukhuset; Onkologkliniken, Linkoeping, , Sweden
Skånes University Hospital, Skånes Department of Onclology, Lund, , Sweden
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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