Safety and Efficacy of BKM120 in Patients With Metastatic Non-small Cell Lung Cancer

This study is currently recruiting participants.
Verified February 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01297491
First received: February 11, 2011
Last updated: February 17, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Non-small Cell Lung Cancer
Drug: BKM120 or Docetaxel
Drug: BKM120 or Docetaxel or Pemetrexed
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Progression Free Survival (PFS) as measured using RECIST 1.1 [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determine Objective Response Rate (ORR) [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]
  • Determine Time to Response (TTR) [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]
  • Determine Duration of Response [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]
  • Determine Overall Survival (OS) [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]
  • Characterize safety as measured by frequency and severity of AEs and lab values [ Time Frame: Until 30 days after last dose ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 122
Study Start Date: May 2011
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Squamous
can receive either BKM120 or Doctaxel
Drug: BKM120 or Docetaxel
Experimental: Non-Squamous
can receive BMK120 or Docetaxel or Pemetrexed
Drug: BKM120 or Docetaxel or Pemetrexed

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed NSCLC with activated PI3K pathway
  • 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 has received previous treatment with PI3K inhibitors
  • 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

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01297491

Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals

  Hide Study Locations
Locations
United States, Arizona
Mayo Clinic - Arizona Mayo Scottsdale AZ Recruiting
*see Various Departments*, Arizona, United States
Contact: Edna Ramos    480-301-4976    ramos.edna@mayo.edu   
Principal Investigator: Helen Ross         
Ironwood Cancer and Research Centers SC Recruiting
Chandler, Arizona, United States, 85224
Contact: Vanessa Tanner       vtanner@ironwoodcrc.com   
Principal Investigator: Mikhail Shtivelband         
Arizona Oncology Associates Tucson (Rudasill & La Cholla) Recruiting
Phoenix, Arizona, United States
Contact: LaTisha Hargrove    520-269-3821    latisha.hargrove@usoncology.com   
Principal Investigator: Richard K. Rosenberg         
United States, Arkansas
Highlands Oncology Group Dept of Highlands Oncology Grp Recruiting
Fayetteville, Arkansas, United States, 72703
Contact: Katherine Holwell    +1 479 872 8130    Katherine.Holwell@ucdenver.edu   
Principal Investigator: Joseph Thaddeus Beck         
United States, California
Cedars Sinai Medical Center Dept.of Cedars-Sinai Med. Ctr. Recruiting
Los Angeles, California, United States, 90048
Contact: Zulema Sanchez    310-423-2276    zulema.sanchez@cshs.org   
Principal Investigator: Ronald B. Natale         
University of California at San Diego, Moores Cancer Ctr SC Recruiting
San Diego, California, United States, 92103
Contact: Anu Iwanefun    858-246-0357    aiwanefun@ucsd.edu   
Principal Investigator: Lyudmila Bazhenova         
United States, Colorado
University of Colorado Univ CO Recruiting
Aurora, Colorado, United States, 80045
Contact: Katherine Holwell    720-848-0603    Katherine.Holwell@ucdenver.edu   
Principal Investigator: Robert Doebele         
Rocky Mountain Cancer Centers Dept. of Rocky Mountain Cancer Recruiting
Greenwood Village, Colorado, United States
Contact: Sara Hartford    303-285-5081    sara.hartford@usoncology.com   
Principal Investigator: Robert M. Jotte         
United States, Florida
H. Lee Moffitt Cancer Center & Research Institute H Lee Moffitt Recruiting
Tampa, Florida, United States, 33612
Contact: Jeff L. Jorski    813-745-6895    jeff.jorski@moffitt.org   
Principal Investigator: Mary Pinder-Schenck         
United States, Georgia
Emory University School of Medicine/Winship Cancer Institute Emory 2 Recruiting
Atlanta, Georgia, United States, 30322
Contact: Antionette D. Hollis    404-778-4326    a.d.hollis@emory.edu   
Principal Investigator: Suresh Ramalingam         
Georgia Regents University GHSU Withdrawn
Augusta, Georgia, United States, 30912
United States, Illinois
University of Chicago Medical Center Unvi Chi Recruiting
Chicago, Illinois, United States, 60546
Contact: Michelle Rainer    773-834-0783    mrainer@medicine.bsd.uchicago.edu   
Principal Investigator: Ravi Salgia         
Rush University Medical Center SC Recruiting
Chicago, Illinois, United States, 60612
Contact: Dawn Paulsen       dawn_paulsen@rush.edu   
Principal Investigator: Mary J Fidler         
United States, Indiana
Indiana University Indiana Univ 2 Withdrawn
Indianapolis, Indiana, United States, 46202
Horizon Oncology Center Horizon Onc Withdrawn
Lafayette, Indiana, United States, 47905
United States, Kansas
University of Kansas Cancer Center Univ of KS Recruiting
Kansas City, Kansas, United States, 66160
Contact: Kelley Chrisman    +1 913 588 4254    kchrisman3@kumc.edu   
Principal Investigator: Chao Hui Huang         
Kansas City Cancer Center KCCC - Southwest Withdrawn
Overland Park, Kansas, United States, 66210
United States, Massachusetts
Massachusetts General Hospital Mass General Recruiting
Boston, Massachusetts, United States, 02114
Contact: Kelly Masone    617-724-1223    kelly_masone@dfci.harvard.edu   
Principal Investigator: Jeffrey Engelman         
Fallon Clinic at Worcester Medical Center Fallon Clinic Worcester Med Recruiting
Worcester, Massachusetts, United States, 01608
Contact: Sonia Martinath    508-595-2212    sonia.martinath@reliantmedicalgroup.org   
Principal Investigator: Saleem Khanani         
United States, Michigan
Wayne State University/Karmanos Cancer Institute Wayne St Karmanos Recruiting
Detroit, Michigan, United States, 48201
Contact: Cleo Connolly    313-576-9454    connollc@karmanos.org   
Principal Investigator: Shirish M. Gadgeel         
United States, Minnesota
Mayo Clinic - Rochester Mayo - Roch. Withdrawn
Rochester, Minnesota, United States, 55905
United States, Missouri
Washington University School Of Medicine-Siteman Cancer Ctr Wash Uni Recruiting
St. Louis, Missouri, United States, 63110
Contact: Ashley Bolden    314-362-6963    abolden@dom.wustl.edu   
Principal Investigator: Saiama Waqar         
United States, Nebraska
University of Nebraska Medical Center CBKM120D2201 Withdrawn
Omaha, Nebraska, United States, 68198
United States, Nevada
Nevada Cancer Institute Dept. of Nevada Cancer (3) Withdrawn
Las Vegas, Nevada, United States, 89135
United States, New Jersey
The Center for Cancer and Hematologic Disease Dept. of the CCHD Withdrawn
Cherry Hill, New Jersey, United States, 08003
Hematology Oncology Associates of Northern New Jersey PA DeptofHem-OncofNorthern NJ (2) Recruiting
Morristown, New Jersey, United States, 07962
Contact: Michelle Mackenzie    +1 973 538 3593 ext.2338    mmackenzie@hoannj.com   
Principal Investigator: Steven Papish         
Overlook Hospital - Carol G Simon Cancer Center Carol G Simon Recruiting
Summit, New Jersey, United States, 07901
Contact: Kathryn Radler       Kathryn.Radler@atlantichealth.org   
Principal Investigator: Dennis Lowenthal         
United States, New York
Roswell Park Cancer Institute Rosewell Recruiting
Buffalo, New York, United States, 14263
Contact: Noelle Lawrence    716-845-4886    noelle.lawrence@roswellpark.org   
Principal Investigator: Grace Dy         
Memorial Sloan Kettering Cancer Center Sloan Kettering Recruiting
New York, New York, United States, 10021
Contact: Melissa Goldstein    646-888-5722    goldstem@mskcc.org   
Principal Investigator: Paul Paik         
United States, North Carolina
Duke University Medical Center Duke 2 Completed
Durham, North Carolina, United States, 27710
United States, Ohio
MetroHealth Medical Center Dept.ofMetroHealthMedCtr.(2) Recruiting
Cleveland, Ohio, United States, 44109-1998
Contact: Kristine McQueen    216-778-4568    kmcqueen@metrohealth.org   
Principal Investigator: Michael Snell         
United States, Oklahoma
University of Oklahoma Health Sciences Center Dept. of Oklahoma Univ. HSC Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Debra Klum    405-271-4022      
Principal Investigator: Mohamad Cherry         
United States, Oregon
Northwest Cancer Specialists Compass Oncology -BKM Recruiting
Portland, Oregon, United States, 97210
Contact: Wendy Koch    360-449-6522    wendy.koch@usoncology.com   
Principal Investigator: Ian A. Schnadig         
United States, Pennsylvania
University of Pittsburgh Medical Center SC-2 Recruiting
Pittsburgh, Pennsylvania, United States
Contact: Aimee McBroom    412-235-1316    mcbrooma@upmc.edu   
Principal Investigator: Mark Socinski         
United States, South Carolina
Medical University of South Carolina MUSC Recruiting
Charleston, South Carolina, United States, 29425
Contact: Kristina Woodruff    843-792-1463    woodrufk@musc.edu   
Principal Investigator: Keisuke Shirai         
United States, Tennessee
Vanderbilt University Medical Center, Clinical Trials Center Vanderbilt 2 Recruiting
Nashville, Tennessee, United States, 37212
Contact: Kathleen Sanders    615-322-4967    kathleen.sanders@Vanderbilt.Edu   
Principal Investigator: Leora Horn         
United States, Texas
Baylor Health Care System/Sammons Cancer Center Baylor Texas Oncology Active, not recruiting
Dallas, Texas, United States, 75246
Texas Oncology, P.A. Austin Location Recruiting
Dallas, Texas, United States, 75251
Contact: Ashli Walker    512-447-2202    ashli.walker@usoncology.com   
Principal Investigator: James Uyeki         
U of TX Southwestern Medical Center - SimmonsCompCancerCtr Clinical Research Office Recruiting
Dallas, Texas, United States, 75390-9151
Contact: Quynh Saporito    214-648-7097    quynh-nhu.saporito@utsouthwestern.edu   
Principal Investigator: Joan H. Schiller         
US Oncology Central Monitoring Withdrawn
Dallas, Texas, United States, 75246
University of Texas/MD Anderson Cancer Center UT/MD Withdrawn
Houston, Texas, United States, 77030-4009
Cancer Therapy & Research Center / UT Health Science Center CTRC 2 Withdrawn
San Antonio, Texas, United States, 78229
United States, Virginia
Virginia Oncology Associates VOA - Lake Wright (2) Recruiting
*see Various Departments*, Virginia, United States
Contact    757-262-4633      
Principal Investigator: John C Paschold         
University of Virginia Health Systems SC-1 Withdrawn
Charlottesville, Virginia, United States, 22908-0334
Oncology Hematology Associates of Southeast Virginia Roanoke Loc Withdrawn
Roanoke, Virginia, United States, 24014
United States, Wisconsin
University of Wisconsin Univ WIsc 2 Recruiting
Madison, Wisconsin, United States, 53792
Contact: Denae Walters    608-262-8665    dmwalters@uwcarbone.wisc.edu   
Principal Investigator: Anne M. Traynor         
Argentina
Novartis Investigative Site Withdrawn
Rosario, Sante Fe, Argentina, S200DSK
Novartis Investigative Site Active, not recruiting
Rio Negro, Viedma, Argentina, 8500
Novartis Investigative Site Completed
Buenos Aires, Argentina, C1050AAK
Novartis Investigative Site Active, not recruiting
Cordoba, Argentina, X5002AOQ
Belgium
Novartis Investigative Site Completed
Brussel, Belgium, 9100
Novartis Investigative Site Completed
Charleroi, Belgium, 6000
Novartis Investigative Site Recruiting
Genk, Belgium, 3600
Novartis Investigative Site Completed
Leuven, Belgium, 3000
Novartis Investigative Site Recruiting
Libramont, Belgium, 6800
Brazil
Novartis Investigative Site Suspended
Salvador, BA, Brazil, 41253-190
Novartis Investigative Site Suspended
Rio de Janeiro, RJ, Brazil, 20230-130
Novartis Investigative Site Suspended
Florianopolis, SC, Brazil, 88034-000
Novartis Investigative Site Suspended
Barretos, SP, Brazil, 14784-400
Novartis Investigative Site Suspended
São Paulo, SP, Brazil, 01246-000
Canada, British Columbia
Novartis Investigative Site Active, not recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Ontario
Novartis Investigative Site Recruiting
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Novartis Investigative Site Terminated
Montreal, Quebec, Canada, H2X 3J4
China, Guangdong
Novartis Investigative Site Not yet recruiting
Guangzhou, Guangdong, China, 510030
China, Shanghai
Novartis Investigative Site Not yet recruiting
Shanghai, Shanghai, China, 200433
China
Novartis Investigative Site Not yet recruiting
Beijing, China, 100039
Novartis Investigative Site Not yet recruiting
Beijing, China, 100036
Novartis Investigative Site Not yet recruiting
Guangzhou, China, 510060
France
Novartis Investigative Site Recruiting
Caen Cedex, France, 14021
Novartis Investigative Site Recruiting
Creteil, France, 94000
Novartis Investigative Site Recruiting
Marseille cedex 20, France, 13915
Novartis Investigative Site Recruiting
Rennes, France, F-35043
Novartis Investigative Site Recruiting
Toulouse Cedex 9, France, 31059
Novartis Investigative Site Recruiting
Villejuif Cedex, France, 94805
Germany
Novartis Investigative Site Recruiting
Berlin, Germany, 13125
Novartis Investigative Site Recruiting
Essen, Germany, 45147
Novartis Investigative Site Recruiting
Grosshansdorf, Germany, 22927
Novartis Investigative Site Withdrawn
Halle (Saale), Germany, 06120
Novartis Investigative Site Recruiting
Heidelberg, Germany, 69120
Novartis Investigative Site Recruiting
Koeln, Germany, 51109
Novartis Investigative Site Recruiting
Muenchen, Germany, 82131
Novartis Investigative Site Recruiting
Nuernberg, Germany, 90419
Novartis Investigative Site Recruiting
Oldenburg, Germany, 26121
Novartis Investigative Site Recruiting
Recklinghausen, Germany, 45657
Hong Kong
Novartis Investigative Site Recruiting
Hongkong, Hong Kong
Hungary
Novartis Investigative Site Recruiting
Budapest, Hungary, 1125
Novartis Investigative Site Recruiting
Budapest, Hungary, 1121
Novartis Investigative Site Recruiting
Deszk, Hungary, 6772
Novartis Investigative Site Recruiting
Mátraháza, Hungary, 3233
Novartis Investigative Site Withdrawn
Szekesfehervar, Hungary, 8000
Novartis Investigative Site Recruiting
Szolnok, Hungary, H-5000
Italy
Novartis Investigative Site Recruiting
Avellino, AV, Italy, 83100
Novartis Investigative Site Recruiting
Genova, GE, Italy, 16132
Novartis Investigative Site Recruiting
Milano, MI, Italy, 20133
Novartis Investigative Site Recruiting
Milano, MI, Italy, 20141
Novartis Investigative Site Withdrawn
Perugia, PG, Italy, 06129
Novartis Investigative Site Recruiting
Parma, PR, Italy, 43100
Novartis Investigative Site Withdrawn
Roma, RM, Italy, 00152
Novartis Investigative Site Recruiting
Udine, UD, Italy, 33100
Japan
Novartis Investigative Site Recruiting
Kurashiki, Okayama, Japan, 710-8602
Novartis Investigative Site Completed
Koto, Tokyo, Japan, 135-8550
Korea, Republic of
Novartis Investigative Site Not yet recruiting
Seoul, Korea, Korea, Republic of, 110 744
Novartis Investigative Site Not yet recruiting
Seoul, Korea, Korea, Republic of, 135-710
Novartis Investigative Site Not yet recruiting
Seoul, Korea, Republic of, 738-736
Netherlands
Novartis Investigative Site Recruiting
Groesbeek, Netherlands, 6561 KE
Novartis Investigative Site Recruiting
Maastricht, Netherlands, 6229 HX
Singapore
Novartis Investigative Site Recruiting
Singapore, Singapore, 169610
Spain
Novartis Investigative Site Recruiting
Sabadell, Barcelona, Spain, 08208
Novartis Investigative Site Recruiting
Barcelona, Cataluña, Spain, 08035
Novartis Investigative Site Recruiting
Mataro, Cataluña, Spain, 08301
Novartis Investigative Site Recruiting
Alicante, Comunidad Valenciana, Spain, 03010
Taiwan
Novartis Investigative Site Recruiting
Tainan 704, Taiwan ROC, Taiwan
Novartis Investigative Site Recruiting
Taipei, Taiwan ROC, Taiwan, 100
Thailand
Novartis Investigative Site Recruiting
Bangkok, Thailand, 10700
Novartis Investigative Site Recruiting
Chiang Mai, Thailand, 50200
Turkey
Novartis Investigative Site Recruiting
Altunizade, Turkey, 34662
Novartis Investigative Site Recruiting
Istanbul, Turkey, 34303
Novartis Investigative Site Recruiting
Izmir, Turkey, 35040
United Kingdom
Novartis Investigative Site Recruiting
Northwood, Middlesex, United Kingdom, HA6 2RN
Novartis Investigative Site Recruiting
Leicester, United Kingdom, LE1 5WW
Novartis Investigative Site Recruiting
London, United Kingdom, SE1 9RT
Novartis Investigative Site Recruiting
Manchester, United Kingdom, M20 4BX
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01297491     History of Changes
Other Study ID Numbers: CBKM120D2201, 2010-024011-14
Study First Received: February 11, 2011
Last Updated: February 17, 2014
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Belgium: Federal Agency for Medicinal Products and Health Products
Brazil: National Health Surveillance Agency
Canada: Health Canada
China: Food and Drug Administration
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Hong Kong: Department of Health
Hungary: National Institute of Pharmacy
Italy: National Institute of Health
Japan: Pharmaceuticals and Medical Devices Agency
Korea: Food and Drug Administration
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Singapore: Health Sciences Authority
Spain: Spanish Agency of Medicines
Taiwan: Department of Health
Thailand: Food and Drug Administration
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Novartis:
NSCLC,
PI3K

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Docetaxel
Pemetrexed
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on April 17, 2014