Safety and Efficacy of BKM120 in Patients With Metastatic Non-small Cell Lung Cancer
NCT ID: NCT01297491
Last Updated: 2016-03-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
63 participants
INTERVENTIONAL
2011-05-31
2014-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Squamous BKM120 100mg qd
Diagnosed patients with non-small cell lung cancer (NSCLC) that progressed after one prior, platinum-based chemotherapy line for metastatic disease.
BKM120
Buparlisib was supplied as 10mg or 50mg capsules. It was administered on a continuous once daily dosing schedule at a dose of 100 mg. The patient was dosed on a flat scale of mg/day and not adjusted to body weight or body surface area.
Non-Squamous BKM120 100mg qd
Diagnosed patients with non-squamous NSCLC that progressed after one or two prior antineoplastic therapy lines for metastatic disease.
BKM120
Buparlisib was supplied as 10mg or 50mg capsules. It was administered on a continuous once daily dosing schedule at a dose of 100 mg. The patient was dosed on a flat scale of mg/day and not adjusted to body weight or body surface area.
Interventions
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BKM120
Buparlisib was supplied as 10mg or 50mg capsules. It was administered on a continuous once daily dosing schedule at a dose of 100 mg. The patient was dosed on a flat scale of mg/day and not adjusted to body weight or body surface area.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Progressive disease after prior systemic antineoplastic treatment(s) for advanced NSCLC
* Archival or fresh tumor biopsy must be available for profiling
* Measurable and/or non-measurable disease as per RECIST 1.1 criteria
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
* Adequate organ function as assessed by laboratory tests
Exclusion Criteria
* Patient with squamous NSCLC has received more than one line of chemotherapy treatment for metastatic disease; patient with non-squamous NSCLC has received more than two lines of systemic antineoplastic treatment for metastatic disease
* Uncontrolled or symptomatic CNS metastases
* Concurrent use of any other approved or investigational antineoplastic agent
* Radiotherapy ≤ 28 days prior to starting study drug
* Major surgery within 28 days prior to starting study drug
* History of clinically significant cardiac dysfunction, mood disorders, or poorly controlled diabetes mellitus
* Current treatment with medication that has a known risk to prolong the QT interval or inducing Torsades de Pointes
* Impairment of gastrointestinal (GI) function
* Chronic treatment with steroids or another immunosuppressive agent.
* Concurrent severe and/or uncontrolled medical condition
* Currently receiving Warfarin or another coumarin derivative
* Known history of HIV infection
* Sensory neuropathy with functional impairment (CTC grade 2 neuropathy, regardless of causality)
* Pregnancy, lactation, or breastfeeding
* Woman of child-bearing potential
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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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
New York, 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
Buenos Aires, Buenos Aires, Argentina
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Córdoba, Córdoba Province, Argentina
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Rio Negro, Viedma, Argentina
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Brussels, , Belgium
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Charleroi, , Belgium
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Genk, , Belgium
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Leuven, , Belgium
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Libramont, , Belgium
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Salvador, Estado de Bahia, Brazil
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Rio de Janeiro, Rio de Janeiro, Brazil
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Florianópolis, Santa Catarina, Brazil
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Barretos, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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Vancouver, British Columbia, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Caen, , France
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Créteil, , France
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Marseille, , France
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Rennes, , France
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Villejuif, , France
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Berlin, , Germany
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Cologne, , Germany
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Essen, , Germany
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Gauting, , Germany
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Großhansdorf, , Germany
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Heidelberg, , Germany
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Nuremberg, , Germany
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Oldenburg, , Germany
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Recklinghausen, , Germany
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Hong Kong, , Hong Kong
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Budapest, , Hungary
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Budapest, , Hungary
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Deszk, , Hungary
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Mátraháza, , Hungary
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Szolnok, , Hungary
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Avellino, AV, Italy
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Genova, GE, Italy
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Milan, MI, Italy
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Milan, MI, Italy
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Parma, PR, Italy
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Udine, UD, Italy
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Kurashiki, Okayama-ken, Japan
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Koto, Tokyo, Japan
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Maastricht, , Netherlands
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Singapore, Singapore, Singapore
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Sabadell, Barcelona, Spain
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Barcelona, Catalonia, Spain
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Mataró, Catalonia, Spain
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Alicante, Valencia, Spain
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Tainan City, Taiwan ROC, Taiwan
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Taipei, Taiwan ROC, Taiwan
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Bangkok, , Thailand
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Chiang Mai, , Thailand
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Izmir, Turkey, Turkey (Türkiye)
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Altunizade, , Turkey (Türkiye)
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Northwood, Middlesex, United Kingdom
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Leicester, , United Kingdom
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London, , United Kingdom
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Manchester, , United Kingdom
Countries
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References
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Vansteenkiste JF, Canon JL, De Braud F, Grossi F, De Pas T, Gray JE, Su WC, Felip E, Yoshioka H, Gridelli C, Dy GK, Thongprasert S, Reck M, Aimone P, Vidam GA, Roussou P, Wang YA, Di Tomaso E, Soria JC. Safety and Efficacy of Buparlisib (BKM120) in Patients with PI3K Pathway-Activated Non-Small Cell Lung Cancer: Results from the Phase II BASALT-1 Study. J Thorac Oncol. 2015 Sep;10(9):1319-1327. doi: 10.1097/JTO.0000000000000607.
Other Identifiers
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2010-024011-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CBKM120D2201
Identifier Type: -
Identifier Source: org_study_id
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