Spots Global Cancer Trial Database for A Study of Sapanisertib, Combination of Sapanisertib With MLN1117, Paclitaxel and Combination of Sapanisertib With Paclitaxel in Women With Endometrial Cancer
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Trial Identification
Brief Title: A Study of Sapanisertib, Combination of Sapanisertib With MLN1117, Paclitaxel and Combination of Sapanisertib With Paclitaxel in Women With Endometrial Cancer
Official Title: A Phase 2, Randomized Study of MLN0128 (a Dual TORC1/2 Inhibitor), MLN0128+MLN1117 (a PI3Kα Inhibitor), Weekly Paclitaxel, or the Combination of Weekly Paclitaxel and MLN0128 in Women With Advanced, Recurrent, or Persistent Endometrial Cancer
Study ID: NCT02725268
Conditions
Study Description
Brief Summary: The primary purpose of this study is to determine if sapanisertib in combination with weekly paclitaxel improves progression-free survival (PFS) compared to weekly paclitaxel alone.
Detailed Description: The drugs being evaluated in this study are sapanisertib and MLN1117. Sapanisertib is being evaluated as a single agent and in combination with paclitaxel or MLN1117 to treat women with advanced, recurrent, or persistent endometrial cancer. This study will evaluate the efficacy and safety of each drug or drug combination. The study will enroll approximately 241 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of 4 treatment groups: * Paclitaxel 80 mg/m\^2 * Paclitaxel 80 mg/m\^2 + Sapanisertib 4 mg * Sapanisertib 30 mg * Sapanisertib 4 mg + MLN1117 200 mg Participants will receive either paclitaxel intravenous (IV) weekly, Paclitaxel IV along with sapanisertib orally, sapanisertib orally, or sapanisertib and MLN1117 orally. This is a multicenter, multinational trial. Participants will make multiple visits to the clinic, with an end of treatment visit (EOT) which will occur 30 to 40 days after receiving their last dose of study drug or before the start of any subsequent anticancer therapy. After EOT, participants will be followed for PFS and overall survival (OS).
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
University of Alabama Comprehensive Cancer Center, Birmingham, Alabama, United States
University of Arizona Cancer Center, Phoenix, Arizona, United States
Marin Cancer Care, Greenbrae, California, United States
University of California San Diego Medical Center, La Jolla, California, United States
University of California at San Francisco (PARENT), San Francisco, California, United States
Stanford School of Medicine, Stanford, California, United States
H. Lee Moffitt Cancer Center and Research Institute, Inc, Tampa, Florida, United States
Florida Cancer Specialists, West Palm Beach, Florida, United States
Augusta University, Augusta, Georgia, United States
Franciscan St. Francis Health, Indianapolis, Indiana, United States
University of Kansas Medical Center Research Institute, Inc., Westwood, Kansas, United States
Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States
Washington University, Saint Louis, Missouri, United States
NYU Langone Medical Center Clinic, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Levine Cancer Institute, Charlotte, North Carolina, United States
Oklahoma University Health Sciences Center, Oklahoma City, Oklahoma, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center Cancer Center at Magee-Womens Hospital, Pittsburgh, Pennsylvania, United States
Sarah Cannon Research Institute, Nashville, Tennessee, United States
University of Texas Southwestern Medical Center, Dallas, Texas, United States
St George Hospital, Kogarah, New South Wales, Australia
Westmead Hospital, Westmead, New South Wales, Australia
Royal Brisbane and Women's Hospital, Herston, Queensland, Australia
Monash Medical Centre Clayton, Clayton, Victoria, Australia
Sunshine Hospital, Footscray, Victoria, Australia
Cabrini Hospital Malvern, Malvern, Victoria, Australia
Peter MacCallum Cancer Centre-East Melbourne, Melbourne, Victoria, Australia
UZ Antwerpen, Edegem, Antwerpen, Belgium
Cliniques Universitaires Saint-Luc, Bruxelles, , Belgium
UZ Leuven, Leuven, , Belgium
Centre Hospitalier Universitaire de Liege Site Sart Tilman, Liege, , Belgium
GasthuisZusters Antwerpen Sint-Augustinus, Wilrijk, , Belgium
Tom Baker Cancer Centre, Calgary, Alberta, Canada
Juravinski Cancer Clinic, Hamilton, Ontario, Canada
LHSC - Victoria Hospital, London, Ontario, Canada
Ottawa Hospital Cancer Centre, Ottawa, Ontario, Canada
University Health Network - Princess Margaret Cancer Centre, Toronto, Ontario, Canada
CHUM Hopital Notre-Dame, Montreal, Quebec, Canada
Universitaetsmedizin Greifswald, Greifswald, Mecklenburg Vorpommern, Germany
Medizinische Hochschule Hannover, Hannover, Niedersachsen, Germany
Universitaetsklinikum Carl Gustav Carus TU Dresden, Dresden, Sachsen, Germany
Universitaetsklinikum Schleswig-Holstein - Campus Luebeck, Luebeck, Schleswig Holstein, Germany
Charite - Universitaetsmedizin Berlin - Campus Virchow-Klinikum, Berlin, , Germany
Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori, Meldola, Forli - Cesena, Italy
Spedali Civili di Brescia, Brescia, , Italy
Ente Ospedaliero Ospedali Galliera, Genova, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, , Italy
IEO Istituto Europeo di Oncologia, Milano, , Italy
Istituto Tumori Napoli Fondazione G. Pascale, Napoli, , Italy
Azienda Unita Sanitaria Locale di Ravenna, Ravenna, , Italy
Istituto Nationale Tumori Regina Elena, Roma, , Italy
Universita degli Studi di Roma "La Sapienza" - Umberto I Policlinico di Roma, Roma, , Italy
Fondazione Policlinico Universitario Agostino Gemelli, Roma, , Italy
Maastricht Universitair Medisch Centrum, Maastricht, Limburg, Netherlands
Academisch Medisch Centrum, Amsterdam, Noord-holland, Netherlands
Erasmus Medisch Centrum Daniel den Hoed, Rotterdam, Zuid-holland, Netherlands
Universitair Medisch Centrum Groningen, Groningen, , Netherlands
Universitair Medisch Centrum Utrecht, Utrecht, , Netherlands
Haukeland universitetssykehus, Kvinneklinikken, Bergen, , Norway
Radiumhospitalet, Oslo, , Norway
Stavanger University Hospital, Stavanger, , Norway
Hospital Universitari Vall d'Hebron, Barcelona, , Spain
MD Anderson Cancer Centre, Madrid, , Spain
Hospital Universitario Ramon y Cajal, Madrid, , Spain
Hospital Universitario Clinico San Carlos, Madrid, , Spain
Hospital Universitario La Paz, Madrid, , Spain
Centro Integral Oncologico Clara Campal, Madrid, , Spain
Instituto Valenciano de Oncologia IVO, Valencia, , Spain
Bristol Haematology and Oncology Centre, Bristol, Avon, United Kingdom
Royal Devon and Exeter Hospital (Wonford), Exeter, Devon, United Kingdom
University College London Hospitals, London, Greater London, United Kingdom
Royal Marsden Hospital, London, Greater London, United Kingdom
Hammersmith Hospital, London, Greater London, United Kingdom
The Christie, Manchester, Greater Manchester, United Kingdom
Royal Marsden Hospital, Sutton, Surrey, United Kingdom
University Hospital Coventry, Coventry, , United Kingdom
Beatson West of Scotland Cancer Centre, Glasgow, , United Kingdom
Contact Details
Name: Medical Director Clinical Science
Affiliation: Millennium Pharmaceuticals, Inc.
Role: STUDY_DIRECTOR
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