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Brief Title: Multicenter Study of Rociletinib Administered to Patients With Previously Treated Mutant EGFR Non-small Cell Lung Cancer
Official Title: TIGER-2: A Phase 2, Open-label, Multicenter, Safety and Efficacy Study of Oral CO-1686 as 2nd Line EGFR-directed TKI in Patients With Mutant EGFR Non-small Cell Lung Cancer (NSCLC)
Study ID: NCT02147990
Brief Summary: The purpose of this study is to evaluate the safety and anti-tumor effect of rociletinib. The trial is open-ended, which means patients will continue to take rociletinib until the study doctor determines it is no longer beneficial for them.
Detailed Description: This is a Phase 2, single arm, open-label, dual cohort, multicenter study evaluating the safety and efficacy of rociletinib administered orally to patients with previously treated mutant EGFR NSCLC. Patients will be enrolled into 2 cohorts. Cohort A will enroll approximately 125 eligible patients who are centrally confirmed T790M-positive. Cohort B will be a continuation of the study and will enroll up to approximately 100 eligible patients who will be either centrally confirmed T790M-positive or T790M-negative. All patients (for Cohort A and B) should have experienced disease progression while on treatment with the first single-agent EGFR-directed TKI (EGFR-TKI) for advanced/metastatic NSCLC. One line of chemotherapy prior to the EGFR-TKI treatment is permissible. The study (Cohorts A and B) will consist of a screening phase to establish study eligibility and document baseline measurements, an open-label treatment phase, in which the patient will receive rociletinib to ascertain safety and efficacy until disease progression as defined by RECIST Version 1.1, clinical tumor progression, or unacceptable toxicity as assessed by the investigator. For patients with clinical progression, radiographic assessment should be performed to document evidence of radiographic progression.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
UCLA Medical Center, Alhambra, California, United States
Comprehensive Blood and Cancer Center, Bakersfield, California, United States
Saint Jude Heritage Healthcare, Fullerton, California, United States
University of California San Diego Moores Cancer Center, La Jolla, California, United States
Northridge Hospital Medical Center, Northridge, California, United States
Cancer Care Associates, Redondo Beach, California, United States
University of California Davis Medical Center, Sacramento, California, United States
University of California San Francisco, San Francisco, California, United States
Coastal Integrative Cancer Care, San Luis Obispo, California, United States
Saint Mary's Regional Cancer Center, Grand Junction, Colorado, United States
Rocky Mountain Cancer Centers, LLP, Lone Tree, Colorado, United States
Yale University School of Medicine, New Haven, Connecticut, United States
Advanced Medical Specialties, Miami, Florida, United States
Cleveland Clinic Florida, Weston, Florida, United States
Northwestern University Feinberg School of Medicine, Chicago, Illinois, United States
University of Illinois Chicago, Chicago, Illinois, United States
Illinois Cancer Specialists, Niles, Illinois, United States
Beth Israel Comprehensive Cancer Center, Boston, Massachusetts, United States
Lahey Hospital and Medical Center, Burlington, Massachusetts, United States
Minnesota Oncology Hematology, P.A, Minneapolis, Minnesota, United States
Mayo Clinic - Rochester, Rochester, Minnesota, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Montefiore Medical Center, Bronx, New York, United States
New York Oncology Hematology, PC, Latham, New York, United States
University of Rochester, Rochester, New York, United States
University Hospitals of Cleveland, Cleveland, Ohio, United States
Cleveland Clinic, Cleveland, Ohio, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
Tennessee Oncology, PLLC, Nashville, Tennessee, United States
Texas Oncology P.A., Amarillo, Texas, United States
USO - Texas Oncology P.A., Arlington, Texas, United States
Texas Oncology-Austin Central, Austin, Texas, United States
Texas Oncology-Beaumont, Beaumont, Texas, United States
Texas Oncology P.A., Bedford, Texas, United States
Texas Oncology P.A., Dallas, Texas, United States
Texas Oncology P.A., Flower Mound, Texas, United States
The Methodist Hospital, Houston, Texas, United States
Texas Oncology - Plano East, Plano, Texas, United States
Virginia Cancer Specialists, Fairfax, Virginia, United States
Northwest Cancer Specialists, P.C., Vancouver, Washington, United States
Yakima Valley Memorial Hospital, North Star Lodge, Yakima, Washington, United States
Icon Cancer Centre, South Brisbane, New South Wales, Australia
Royal North Shore Hospital, Sydney, New South Wales, Australia
Westmead Hospital, Westmead, New South Wales, Australia
Flinders Medical Centre, Bedford Park, South Australia, Australia
Princess Margaret Hospital, Toronto, Ontario, Canada
Centre Hospitalier Regional Universitaire (CHRU) de Besancon - L'Hopital Jean Minjoz, Besançon, Franche-comte, France
Hôpital Tenon, Paris, Ile-de-france, France
Institut Gustave Roussy, Villejuif, Ile-de-France, France
Institut de Cancérologie de l'Ouest - René Gauducheau, Saint Herblain cedex, PAYS DE LA Loire, France
Centre Hospitalier Lyon Sud, Pierre Bénité cedex, Rhone-alpes, France
Centre Hospitalier Universitaire Côte de Nacre, Caen, , France
Centre Hospitalier Universitaire Hôpital Nord, Marseille Cedex 20, , France
Asklepios Fachkliniken München-Gauting, Gauting, Bayern, Germany
Klinikum Innenstadt LMU, München, Bayern, Germany
Goethe-Universität Frankfurt am Main, Frankfurt am Main, Hessen, Germany
Pius Hospital Oldenburg, Oldenburg, Niedersachsen, Germany
Universitaetsklinikum Bonn - Zentrum fuer Innere Medizin - Medizinische Klinik und Poliklink III, Bonn, Nordrhein-westfalen, Germany
Universitätsklinikum Essen, Essen, Nordrhein-westfalen, Germany
Universitätsklinikum Köln, Köln, Nordrhein-westfalen, Germany
LungenClinic Großhansdorf GmbH, Großhansdorf, Schleswig-holstein, Germany
Evangelische Lungenklinik Berlin, Berlin, , Germany
Queen Mary Hospital, Hong Kong, , Hong Kong
Chungbuk National University Hospital, Chungju, Chungcheongbuk-do, Korea, Republic of
National Cancer Center, Goyang-si, Gyeonggi-do, Korea, Republic of
Gachon University Gil Medical Center, Incheon, Gyeonggi-do, Korea, Republic of
Dong-A University Hospital, Busan, , Korea, Republic of
Inha University Hospital, Incheon, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Seoul Saint Mary's Hospital, Seoul, , Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Antoni van Leeuwenhoek Hospital, Amsterdam, Noord-holland, Netherlands
Vrije Universiteit Medisch Centrum, Amsterdam, , Netherlands
Hospital Universitario Virgen del Rocio, Seville, Sevilla, Spain
Hospital Universitari Germans Trias i Pujol, Badalona, , Spain
Hospital Vall d´Hebrón, Barcelona, , Spain
Hospital Universitario Quirón Dexeus, Barcelona, , Spain
Hospital Universitario La Paz, Madrid, , Spain
Centre Hospitalier Universitaire Vaudoise, Lausanne, Vaud, Switzerland
Taipei Veterans General Hospital, Taipei, Taipei CITY, Taiwan
Chang Gung Memorial Hospital Linkou, Taoyuan, Tao-Yuan, Taiwan
China Medical University Hospital, Taichung, , Taiwan
Taichung Veterans General Hospital, Taichung, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Cambridge University Hospitals NHS Foundation Trust, Cambridge, England, United Kingdom
Guy's and Saint Thomas NHS Foundation Trust, London, Greater London, United Kingdom
Royal Marsden Hospital, London, Greater London, United Kingdom
Royal Marsden NHS Trust, Sutton, Surrey, United Kingdom
University College Hospital, London, , United Kingdom