Trial record 1 of 1 for:    NCT01297491
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Safety and Efficacy of BKM120 in Patients With Metastatic Non-small Cell Lung Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01297491
First received: February 11, 2011
Last updated: July 15, 2014
Last verified: July 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 ]

Enrollment: 63
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Hide Study Locations
Locations
United States, Arizona
Ironwood Cancer and Research Centers SC
Chandler, Arizona, United States, 85224
Arizona Oncology Associates Tucson (Rudasill & La Cholla)
Phoenix, Arizona, United States
Mayo Clinic - Arizona Mayo Scottsdale AZ
Scottsdale, Arizona, United States
United States, Arkansas
Highlands Oncology Group Dept of Highlands Oncology Grp
Fayetteville, Arkansas, United States, 72703
United States, California
Cedars Sinai Medical Center Dept.of Cedars-Sinai Med. Ctr.
Los Angeles, California, United States, 90048
University of California at San Diego, Moores Cancer Ctr SC
San Diego, California, United States, 92103
United States, Colorado
University of Colorado Univ CO
Aurora, Colorado, United States, 80045
Rocky Mountain Cancer Centers Dept. of Rocky Mountain Cancer
Greenwood Village, Colorado, United States
United States, Florida
H. Lee Moffitt Cancer Center & Research Institute H Lee Moffitt
Tampa, Florida, United States, 33612
United States, Georgia
Emory University School of Medicine/Winship Cancer Institute Emory 2
Atlanta, Georgia, United States, 30322
United States, Illinois
University of Chicago Medical Center Unvi Chi
Chicago, Illinois, United States, 60546
Rush University Medical Center SC
Chicago, Illinois, United States, 60612
United States, Kansas
University of Kansas Cancer Center Univ of KS
Kansas City, Kansas, United States, 66160
United States, Massachusetts
Massachusetts General Hospital Mass General
Boston, Massachusetts, United States, 02114
Fallon Clinic at Worcester Medical Center Fallon Clinic Worcester Med
Worcester, Massachusetts, United States, 01608
United States, Michigan
Wayne State University/Karmanos Cancer Institute Wayne St Karmanos
Detroit, Michigan, United States, 48201
United States, Missouri
Washington University School of Medicine Wash Univ.
St. Louis, Missouri, United States, 63110
United States, New Jersey
Hematology Oncology Associates of Northern New Jersey PA DeptofHem-OncofNorthern NJ (2)
Morristown, New Jersey, United States, 07962
Overlook Hospital - Carol G Simon Cancer Center Carol G Simon
Summit, New Jersey, United States, 07901
United States, New York
Roswell Park Cancer Institute Rosewell
Buffalo, New York, United States, 14263
Memorial Sloan Kettering Cancer Center Sloan Kettering
New York, New York, United States, 10021
United States, North Carolina
Duke University Medical Center Duke 2
Durham, North Carolina, United States, 27710
United States, Ohio
MetroHealth Medical Center Dept.ofMetroHealthMedCtr.(2)
Cleveland, Ohio, United States, 44109-1998
United States, Oklahoma
University of Oklahoma Health Sciences Center Dept. of Oklahoma Univ. HSC
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Northwest Cancer Specialists Compass Oncology -BKM
Portland, Oregon, United States, 97210
United States, Pennsylvania
University of Pittsburgh Medical Center SC-2
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
Medical University of South Carolina MUSC
Charleston, South Carolina, United States, 29425
United States, Texas
Baylor Health Care System/Sammons Cancer Center Baylor Texas Oncology
Dallas, Texas, United States, 75246
U of TX Southwestern Medical Center - SimmonsCompCancerCtr Clinical Research Office
Dallas, Texas, United States, 75390-9151
Texas Oncology, P.A. Austin Location
Dallas, Texas, United States, 75251
United States, Virginia
Virginia Oncology Associates VOA - Lake Wright (2)
*see Various Departments*, Virginia, United States
United States, Wisconsin
University of Wisconsin Univ WIsc 2
Madison, Wisconsin, United States, 53792
Argentina
Novartis Investigative Site
Rio Negro, Viedma, Argentina, 8500
Novartis Investigative Site
Buenos Aires, Argentina, C1050AAK
Novartis Investigative Site
Cordoba, Argentina, X5002AOQ
Belgium
Novartis Investigative Site
Brussel, Belgium, 1090
Novartis Investigative Site
Charleroi, Belgium, 6000
Novartis Investigative Site
Genk, Belgium, 3600
Novartis Investigative Site
Leuven, Belgium, 3000
Novartis Investigative Site
Libramont, Belgium, 6800
Brazil
Novartis Investigative Site
Salvador, BA, Brazil, 41253-190
Novartis Investigative Site
Rio de Janeiro, RJ, Brazil, 20230-130
Novartis Investigative Site
Florianopolis, SC, Brazil, 88034-000
Novartis Investigative Site
Barretos, SP, Brazil, 14784-400
Novartis Investigative Site
São Paulo, SP, Brazil, 01246-000
Canada, British Columbia
Novartis Investigative Site
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Ontario
Novartis Investigative Site
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Novartis Investigative Site
Montreal, Quebec, Canada, H2X 3J4
France
Novartis Investigative Site
Caen Cedex, France, 14021
Novartis Investigative Site
Creteil, France, 94000
Novartis Investigative Site
Marseille cedex 20, France, 13915
Novartis Investigative Site
Rennes, France, F-35043
Novartis Investigative Site
Villejuif Cedex, France, 94805
Germany
Novartis Investigative Site
Berlin, Germany, 13125
Novartis Investigative Site
Essen, Germany, 45147
Novartis Investigative Site
Grosshansdorf, Germany, 22927
Novartis Investigative Site
Heidelberg, Germany, 69120
Novartis Investigative Site
Koeln, Germany, 51109
Novartis Investigative Site
Muenchen, Germany, 82131
Novartis Investigative Site
Nuernberg, Germany, 90419
Novartis Investigative Site
Oldenburg, Germany, 26121
Novartis Investigative Site
Recklinghausen, Germany, 45657
Hong Kong
Novartis Investigative Site
Hongkong, Hong Kong
Hungary
Novartis Investigative Site
Budapest, Hungary, 1121
Novartis Investigative Site
Budapest, Hungary, 1125
Novartis Investigative Site
Deszk, Hungary, 6772
Novartis Investigative Site
Mátraháza, Hungary, 3233
Novartis Investigative Site
Szolnok, Hungary, H-5000
Italy
Novartis Investigative Site
Avellino, AV, Italy, 83100
Novartis Investigative Site
Genova, GE, Italy, 16132
Novartis Investigative Site
Milano, MI, Italy, 20141
Novartis Investigative Site
Milano, MI, Italy, 20133
Novartis Investigative Site
Parma, PR, Italy, 43100
Novartis Investigative Site
Udine, UD, Italy, 33100
Japan
Novartis Investigative Site
Kurashiki, Okayama, Japan, 710-8602
Novartis Investigative Site
Koto, Tokyo, Japan, 135-8550
Netherlands
Novartis Investigative Site
Maastricht, Netherlands, 6229 HX
Singapore
Novartis Investigative Site
Singapore, Singapore, 169610
Spain
Novartis Investigative Site
Sabadell, Barcelona, Spain, 08208
Novartis Investigative Site
Barcelona, Catalunya, Spain, 08035
Novartis Investigative Site
Mataro, Cataluña, Spain, 08301
Novartis Investigative Site
Alicante, Comunidad Valenciana, Spain, 03010
Taiwan
Novartis Investigative Site
Tainan 704, Taiwan ROC, Taiwan
Novartis Investigative Site
Taipei, Taiwan ROC, Taiwan, 100
Thailand
Novartis Investigative Site
Bangkok, Thailand, 10700
Novartis Investigative Site
Chiang Mai, Thailand, 50200
Turkey
Novartis Investigative Site
Altunizade, Turkey, 34662
Novartis Investigative Site
Izmir, Turkey, 35040
United Kingdom
Novartis Investigative Site
Northwood, Middlesex, United Kingdom, HA6 2RN
Novartis Investigative Site
Leicester, United Kingdom, LE1 5WW
Novartis Investigative Site
London, United Kingdom, SE1 9RT
Novartis Investigative Site
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: July 15, 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
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Enzyme Inhibitors
Folic Acid Antagonists

ClinicalTrials.gov processed this record on October 16, 2014