Spots Global Cancer Trial Database for p53 Suppressor Activation in Recurrent High Grade Serous Ovarian Cancer, a Phase Ib/II Study of Systemic Carboplatin Combination Chemotherapy With or Without APR-246
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Trial Identification
Brief Title: p53 Suppressor Activation in Recurrent High Grade Serous Ovarian Cancer, a Phase Ib/II Study of Systemic Carboplatin Combination Chemotherapy With or Without APR-246
Official Title: PiSARRO: p53 Suppressor Activation in Recurrent High Grade Serous Ovarian Cancer, a Phase Ib/II Study of Systemic Carboplatin Combination Chemotherapy With or Without APR-246
Study ID: NCT02098343
Study Description
Brief Summary: The purpose of this study is to make a preliminary assessment of the efficacy of a combined APR-246 and carboplatin/PLD chemotherapy regimen, compared with carboplatin/PLD chemotherapy regimen alone, in patients with platinum sensitive recurrent high grade serous ovarian cancer (HGSOC) with mutated p53. In addition, the study aims to assess the safety profile of the combined APR-246 and carboplatin/PLD chemotherapy regimen compared with carboplatin/PLD chemotherapy regimen alone, to evaluate potential biomarkers, and to assess the biological activity in tumor and surrogate tissues. The trial will enroll up to a maximum of 400 patients.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
UCLA, Los Angeles, California, United States
University of Chicago, Chicago, Illinois, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States
Oregon Health & Science University, Portland, Oregon, United States
The University of Pennsylvania, Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
UPMC Hillman Cancer Center, Magee-Womens Hospital, Pittsburgh, Pennsylvania, United States
Vanderbilt University Medical Center, Nashville, Tennessee, United States
Parkland, UT Southwestern Medical Center, Dallas, Texas, United States
University of Texas Southwestern Medical Center, Dallas, Texas, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Massey Cancer Center, Virginia Commonwealth University, Richmond, Virginia, United States
Swedish Cancer Institute, Seattle, Washington, United States
Antwerp University Hospital, Antwerpen, , Belgium
Institut Jules Bordet, Brussels, , Belgium
Cliniques Universitaires Saint Luc, Brussels, , Belgium
Medische oncologie, Universitair Ziekenhuis Gent, Gent, , Belgium
Leuven University Hospitals, Leuven, , Belgium
Centre Léon Bérard, Lyon, , France
Centre Hospitalier Lyon Sud, Lyon, , France
Centre Catherine de Sienne, Nantes, , France
Institut Curie, Paris, , France
Hôpital des Diaconesses (Site Reuilly), Paris, , France
Centre Paul Strass, Strasbourg, , France
Institut Gustave Roussy, Villejuif, , France
Praxisklinik, Krebsheilkunde für Frauen, Berlin, , Germany
Charité Campus Virchow-Klinikum, Berlin, , Germany
Universitätsklinikum Carl Gustav Carus, Dresden, , Germany
Universitätsklinikum Hamburg-Eppendorf, Hamburg, , Germany
Universitätsfrauenklinik Ulm, Ulm, , Germany
Academisch Medisch Centrum, Amsterdam, , Netherlands
Universitair Medisch Centrum Groningen, Groningen, , Netherlands
Leids Universitair Medisch Centrum, Leiden, , Netherlands
Academisch Ziekenhuis Maastricht, Maastricht, , Netherlands
Institut Català d'Oncologia, Hospital Germans Trias i Pujol, Badalona, , Spain
Hospital Vall d'Hebron, Barcelona, , Spain
Hospital Universitario Reina Sofia, Córdoba, , Spain
Centro Oncologico MD Anderson, Madrid, , Spain
Hospital Universitario Ramón y Cajal, Madrid, , Spain
Hospital Universitario Fundación Jiménez Díaz, Madrid, , Spain
Hospital Universitario HM Sanchinarro, Madrid, , Spain
Hospital Universitario Virgen de la Victoria, Málaga, , Spain
Hospital Clinico Universitario de Valencia, Valencia, , Spain
Hospital Universitario Araba, Vitoria-Gasteiz, , Spain
Hospital Clínico Universitario Lozano Blesa, Zaragosa, , Spain
Karolinska University Hospital, Stockholm, , Sweden
Bristol Haematology & Oncology Centre, University Hospitals Bristol, Bristol, , United Kingdom
Cambridge Cancer Trials Centre, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge, , United Kingdom
Edinburgh Cancer Research Centre, The University of Edinburgh, Edinburgh, , United Kingdom
The Clatterbridge Cancer Center NHS Foundation Trust, Liverpool, , United Kingdom
The Royal Marsden NHS Foundation Trust, London, , United Kingdom
Imperial College London, Hammersmith Hospital Campus, London, , United Kingdom
The Christie NHS Foundation Trust, Manchester, , United Kingdom
Contact Details
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