Spots Global Cancer Trial Database for A Study of AT13387 in Patients With Non-Small Cell Lung Cancer (NSCLC) Alone and in Combination With Crizotinib
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Trial Identification
Brief Title: A Study of AT13387 in Patients With Non-Small Cell Lung Cancer (NSCLC) Alone and in Combination With Crizotinib
Official Title: A Study of HSP90 Inhibitor AT13387 Alone and in Combination With Crizotinib in the Treatment of Non-small Cell Lung Cancer (NSCLC)
Study ID: NCT01712217
Conditions
Study Description
Brief Summary: The purpose of the study is to evaluate safety and efficacy of AT13387 Alone and in Combination with Crizotinib in the Treatment of Non-small Cell Lung Cancer.
Detailed Description: This is a 3-part phase 1-2 study in patients with anaplastic lymphoma kinase (ALK) + or other potentially crizotinib-sensitive NSCLC who have been receiving crizotinib. Part A is a single-arm, Phase 1, open-label, dose escalation design in patients with NSCLC who have already been receiving crizotinib for at least 8 weeks and continue to tolerate therapy. Part B is a Phase 2, open-label, randomized continuation design comparing crizotinib alone versus the combination of crizotinib + AT13387 at the maximum tolerated dose established in Part A. Part C is an open-label, randomized, Phase 2, Simon's 2 stage design evaluating single agent AT13387 or combination AT13387 + crizotinib at the MTD established in Part A in patients who progressed on crizotinib at any time.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Mayo Clinic-Scottsdale, Scottsdale, Arizona, United States
University of California, San Diego Medical Center, La Jolla, California, United States
USC Norris Comprehensive Cancer Center, Los Angeles, California, United States
UCLA Medical Center, Los Angeles, California, United States
Sharp Clinical Oncology Research-Sharp Memorial Hospital, San Diego, California, United States
Innovative Clinical Research Institute, Whittier, California, United States
University of Colorado Denver, Aurora, Colorado, United States
Yale University School of Medicine-Yale Cancer Center, New Haven, Connecticut, United States
Christiana Hospital, Newark, Delaware, United States
Florida Hospital Cancer Institute, Orlando, Florida, United States
H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida, United States
Northwestern University The Feinberg School of Medicine, Chicago, Illinois, United States
University of Chicago, Chicago, Illinois, United States
Indiana University Melvin and and Bren Simon Cancer Center, Indianapolis, Indiana, United States
University of Michigan Medical Center, Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States
Mayo Clinic-Rochester, Rochester, Minnesota, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
University of Nebraska Medical Center Eppley Cancer Center, Omaha, Nebraska, United States
Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire, United States
Montefiore Medical Center, Bronx, New York, United States
Columbia University Medical Center, New York, New York, United States
Duke University Medical Center, Durham, North Carolina, United States
Cone Health Cancer Center, Greensboro, North Carolina, United States
Oncology Hematology in Cincinnati, Cincinnati, Ohio, United States
University of Cincinnati Cancer Institute, Cincinnati, Ohio, United States
Cleveland Clinic, Cleveland, Ohio, United States
Ohio State University Medical Center, Columbus, Ohio, United States
Providence Portland Medical Center, Portland, Oregon, United States
The Pennsylvania State University-Penn State, Hershey, Pennsylvania, United States
Thomas Jefferson University, Philadelphia, Pennsylvania, United States
The West Clinic, Germantown, Tennessee, United States
Sarah Cannon Research Institute, Nashville, Tennessee, United States
University of Texas Southwestern Medical Center, Dallas, Texas, United States
Virginia Cancer Specialists, Fairfax, Virginia, United States
Swedish Cancer Institute, Seattle, Washington, United States
University of Washington Medical Center, Seattle, Washington, United States
University of Wisconsin-Carbone Cancer Center, Madison, Wisconsin, United States
Atlantic Clinical Cancer Research Unit, Halifax, Nova Scotia, Canada
McGill University Health Center, Montreal, Quebec, , Canada
Institut Universitaire de Cardiologie et de Pneumologie De Quebec, Sainte-Foy, Quebec, , Canada
Princess Margaret Hospital, Toronto, Ontario, , Canada
Cancer Care Manitoba, Winnipeg, , Canada
Centre Hospitalier Regional Universitaire Besancon, Besancon Cedex, , France
CHU de Caen-Hopital Cote de Nacre, Caen, , France
Hopital Saint Antoine, Creteil Cedex, , France
Centre Hospitalier de Grenoble, Grenoble, , France
CHRU de Lille, Lille cedex, , France
Institut Paoli-Calmettes, Marseille, , France
Hopital Tenon, Paris, , France
Centre Hospitalier Lyon Sud, Pierre-Benite Cedex, , France
CHU Toulouse-Hopital Larrey, Toulouse, , France
Institut Gustave Roussy, Villejuif, , France
Chungbuk National University Hospital, Cheongju-si, , Korea, Republic of
The Catholic University of Korea, St. Vincent's Hospital, Gyeonggi-do, , Korea, Republic of
Chonnam National University Hwasun Hospital, Hwasun-gun Jeonnam, , Korea, Republic of
National Cancer Center, Korea, , Korea, Republic of
Seoul National University Bundang Hospital, Seongnam, , Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Hospital Germans Trias i Pujol, Badalona, , Spain
Hospital Universitari Quiron Dexeus Barcelona, Barcelona, , Spain
Centro Integral Oncologico Clara Campal, Madrid, , Spain
Hospital Regional Universitario de Malaga, Malaga, , Spain
Contact Details
Name: Jean-Charles Soria, MD
Affiliation: Gustave Roussy, Cancer Campus, Grand Paris
Role: PRINCIPAL_INVESTIGATOR
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