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Brief Title: Safety and Efficacy of BKM120 in Patients With Metastatic Non-small Cell Lung Cancer
Official Title: An Open Label Two-stage Study of Orally Administered BKM120 in Patients With Metastatic Non-small Cell Lung Cancer With Activated PI3K Pathway
Study ID: NCT01297491
Brief Summary: The purpose of this two-stage phase II study is to assess the efficacy of BKM120, as measured by determining the progression free survival (PFS), in patients with pretreated metastatic Non-small Cell Lung Cancer (NSCLC) that exhibits PI3K pathway activation. BKM120 will be investigated in two groups of NSCLC patients according to the histology of the cancer: squamous and non-squamous.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Ironwood Cancer and Research Centers SC, Chandler, Arizona, United States
Arizona Oncology Associates Tucson (Rudasill & La Cholla), Phoenix, Arizona, United States
Mayo Clinic - Arizona Mayo Scottsdale AZ, Scottsdale, Arizona, United States
Highlands Oncology Group Dept of Highlands Oncology Grp, Fayetteville, Arkansas, United States
Cedars Sinai Medical Center Dept.of Cedars-Sinai Med. Ctr., Los Angeles, California, United States
University of California at San Diego, Moores Cancer Ctr SC, San Diego, California, United States
University of Colorado Univ CO, Aurora, Colorado, United States
Rocky Mountain Cancer Centers Dept. of Rocky Mountain Cancer, Greenwood Village, Colorado, United States
H. Lee Moffitt Cancer Center & Research Institute H Lee Moffitt, Tampa, Florida, United States
Emory University School of Medicine/Winship Cancer Institute Emory 2, Atlanta, Georgia, United States
Rush University Medical Center SC, Chicago, Illinois, United States
University of Chicago Medical Center Unvi Chi, Chicago, Illinois, United States
University of Kansas Cancer Center Univ of KS, Kansas City, Kansas, United States
Massachusetts General Hospital Mass General, Boston, Massachusetts, United States
Fallon Clinic at Worcester Medical Center Fallon Clinic Worcester Med, Worcester, Massachusetts, United States
Karmanos Cancer Institute Wayne St Karmanos, Detroit, Michigan, United States
Washington University School of Medicine Washington University (16), St. Louis, Missouri, United States
Hematology Oncology Associates of Northern New Jersey PA DeptofHem-OncofNorthern NJ (2), Morristown, New Jersey, United States
Overlook Hospital - Carol G Simon Cancer Center Carol G Simon, Summit, New Jersey, United States
Roswell Park Cancer Institute Rosewell, Buffalo, New York, United States
Memorial Sloan Kettering Cancer Center Sloan Kettering, NY, New York, United States
Duke University Medical Center Duke 2, Durham, North Carolina, United States
MetroHealth Medical Center Dept.ofMetroHealthMedCtr.(2), Cleveland, Ohio, United States
University of Oklahoma Health Sciences Center Dept. of Oklahoma Univ. HSC, Oklahoma City, Oklahoma, United States
Northwest Cancer Specialists Compass Oncology -BKM, Portland, Oregon, United States
University of Pittsburgh Medical Center SC-2, Pittsburgh, Pennsylvania, United States
Medical University of South Carolina MUSC, Charleston, South Carolina, United States
Baylor Health Care System/Sammons Cancer Center Baylor Texas Oncology, Dallas, Texas, United States
Texas Oncology South Texas Oncology, Dallas, Texas, United States
U of TX Southwestern Medical Center - SimmonsCompCancerCtr Clinical Research Office, Dallas, Texas, United States
Virginia Oncology Associates VOA - Lake Wright (2), *see Various Departments*, Virginia, United States
University of Wisconsin Univ WIsc 2, Madison, Wisconsin, United States
Novartis Investigative Site, Rio Negro, Viedma, Argentina
Novartis Investigative Site, Buenos Aires, , Argentina
Novartis Investigative Site, Cordoba, , Argentina
Novartis Investigative Site, Brussel, , Belgium
Novartis Investigative Site, Charleroi, , Belgium
Novartis Investigative Site, Genk, , Belgium
Novartis Investigative Site, Leuven, , Belgium
Novartis Investigative Site, Libramont, , Belgium
Novartis Investigative Site, Salvador, BA, Brazil
Novartis Investigative Site, Rio de Janeiro, RJ, Brazil
Novartis Investigative Site, Florianopolis, SC, Brazil
Novartis Investigative Site, Barretos, SP, Brazil
Novartis Investigative Site, São Paulo, SP, Brazil
Novartis Investigative Site, Vancouver, British Columbia, Canada
Novartis Investigative Site, Toronto, Ontario, Canada
Novartis Investigative Site, Montreal, Quebec, Canada
Novartis Investigative Site, Caen Cedex, , France
Novartis Investigative Site, Creteil, , France
Novartis Investigative Site, Marseille cedex 20, , France
Novartis Investigative Site, Rennes, , France
Novartis Investigative Site, Villejuif Cedex, , France
Novartis Investigative Site, Berlin, , Germany
Novartis Investigative Site, Essen, , Germany
Novartis Investigative Site, Gauting, , Germany
Novartis Investigative Site, Grosshansdorf, , Germany
Novartis Investigative Site, Heidelberg, , Germany
Novartis Investigative Site, Koeln, , Germany
Novartis Investigative Site, Nuernberg, , Germany
Novartis Investigative Site, Oldenburg, , Germany
Novartis Investigative Site, Recklinghausen, , Germany
Novartis Investigative Site, Hongkong, , Hong Kong
Novartis Investigative Site, Budapest, , Hungary
Novartis Investigative Site, Budapest, , Hungary
Novartis Investigative Site, Deszk, , Hungary
Novartis Investigative Site, Mátraháza, , Hungary
Novartis Investigative Site, Szolnok, , Hungary
Novartis Investigative Site, Avellino, AV, Italy
Novartis Investigative Site, Genova, GE, Italy
Novartis Investigative Site, Milano, MI, Italy
Novartis Investigative Site, Milano, MI, Italy
Novartis Investigative Site, Parma, PR, Italy
Novartis Investigative Site, Udine, UD, Italy
Novartis Investigative Site, Kurashiki, Okayama, Japan
Novartis Investigative Site, Koto, Tokyo, Japan
Novartis Investigative Site, Maastricht, , Netherlands
Novartis Investigative Site, Singapore, , Singapore
Novartis Investigative Site, Sabadell, Barcelona, Spain
Novartis Investigative Site, Barcelona, Catalunya, Spain
Novartis Investigative Site, Mataro, Cataluña, Spain
Novartis Investigative Site, Alicante, Comunidad Valenciana, Spain
Novartis Investigative Site, Tainan 704, Taiwan ROC, Taiwan
Novartis Investigative Site, Taipei, Taiwan ROC, Taiwan
Novartis Investigative Site, Bangkok, , Thailand
Novartis Investigative Site, Chiang Mai, , Thailand
Novartis Investigative Site, Altunizade, , Turkey
Novartis Investigative Site, Izmir, , Turkey
Novartis Investigative Site, Northwood, Middlesex, United Kingdom
Novartis Investigative Site, Leicester, , United Kingdom
Novartis Investigative Site, London, , United Kingdom
Novartis Investigative Site, Manchester, , United Kingdom
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR