LDK378 Versus Chemotherapy in ALK Rearranged (ALK Positive) Patients Previously Treated With Chemotherapy (Platinum Doublet) and Crizotinib

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01828112
First received: April 2, 2013
Last updated: June 23, 2014
Last verified: June 2014
  Purpose

The primary purpose of the study is to compare the antitumor activity of LDK378 vs. chemotherapy in patients previously treated with chemotherapy (platinum doublet) and crizotinib.


Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: LDK378
Drug: pemetrexed
Drug: docetaxel
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III, Multicenter, Randomized, Open-label Study of Oral LDK378 Versus Standard Chemotherapy in Adult Patients With ALK-rearranged (ALK-positive) Advanced Non-small Cell Lung Cancer Who Have Been Treated Previously With Chemotherapy (Platinum Doublet) and Crizotinib

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Progression Free Survival (PFS) [ Time Frame: Month 18 ] [ Designated as safety issue: No ]
    PFS which is defined as the time from the date of randomization to the date of the first radiologically documented disease progression or death due to any cause.


Secondary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: Month 18 ] [ Designated as safety issue: No ]
    OS defined as time from date of randomization to date of death due to any cause

  • Overall Response Rate (ORR) [ Time Frame: Month 18 ] [ Designated as safety issue: No ]
    ORR is defined as the proportion of patients with a best overall response defined as complete response (CR) or partial response (PR); (CR+PR)

  • Duration of Response (DOR) [ Time Frame: Month 18 ] [ Designated as safety issue: No ]
    DOR is defined as the time from date of first documented CR or PR to date of first documented disease progression or death due to underlying cancer

  • Disease Control Rate (DCR) [ Time Frame: Month 18 ] [ Designated as safety issue: No ]
    DCR is defined as the proportion of patients with best overall response of CR, PR, or stable disease (SD)

  • Time to response (TTR) [ Time Frame: Month 18 ] [ Designated as safety issue: No ]
    TTR is defined as the time from date of randomization to date of first documented response (CR or PR)


Estimated Enrollment: 236
Study Start Date: June 2013
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LDK378 Drug: LDK378
Oral LDK378 750 mg once daily
Active Comparator: pemetrexed or docetaxel Drug: pemetrexed
pemetrexed is 500 mg/m2 IV every 21 days
Drug: docetaxel
docetaxel is 75 mg/m2 every 21 days

  Eligibility

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

Inclusion Criteria:

  1. Patient has a histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK) positive as assessed by the FDA approved Abbott FISH Test.
  2. Patient has stage IIIB or IV diagnosis and must have received one or two prior regimens (including platinum- doublet) of cytotoxic chemotherapy for the treatment of locally advanced or metastatic NSCLC.
  3. Patient has at least one measurable lesion as defined by RECIST 1.1. A previously irradiated site lesion may only be counted as a target lesion if there is clear sign of progression since the irradiation

Exclusion Criteria:

  1. Patient with known hypersensitivity to any of the excipients of LDK378 (microcrystalline cellulose, mannitol, crospovidone, colloidal silicon dioxide and magnesium stearate)
  2. Patient with a history of severe hypersensitivity reaction to pemetrexed or docetaxel or any known excipients of these drugs.
  3. Patient with symptomatic central nervous system (CNS) metastases who is neurologically unstable or has required increasing doses of steroids within the 2 weeks prior to screening to manage CNS symptoms.
  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: NCT01828112

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

  Hide Study Locations
Locations
United States, Arizona
Mayo Clinic - Arizona SC Withdrawn
Scottsdale, Arizona, United States
Arizona Oncology Associates PC- NAHOA Recruiting
Sedona, Arizona, United States, 86336
Contact: Taqi Mohammad    928-204-4163      
Principal Investigator: Deborah L. Lindquist         
United States, Arkansas
Highlands Oncology Group SC-1 Recruiting
Fayetteville, Arkansas, United States, 72703
Contact: Jennifer M. Manos    479-936-9900    amoore@hogonc.com   
Principal Investigator: Eric S. Schaefer         
Genesis Cancer Center SC Recruiting
Hot Springs, Arkansas, United States, 71913
Contact: Lori Fulenwider       lfulenwider@genesiscancercenter.com   
Principal Investigator: Timothy Webb         
Hematology Oncology Services of Arkansas SC Withdrawn
Little Rock, Arkansas, United States, 72205
United States, California
Shapiro & Stafford & Yee & Polanski Dept of Onc Withdrawn
Arcadia, California, United States, 91007
Bay Area Cancer Research SC Withdrawn
Concord, California, United States, 94520
City of Hope National Medical Center SC-3 Withdrawn
Duarte, California, United States, 91010-3000
Coast Hematology Oncology Associates Onc Dept Withdrawn
Long Beach, California, United States, 90806
University of California at Los Angeles SC-7 Withdrawn
Los Angeles, California, United States, 90095
The Angeles Clinic and Research Institute SC Not yet recruiting
Los Angeles, California, United States, 90025
Contact: Perry Garcia    310-231-2181    pgarcia@theangelesclinic.org   
Principal Investigator: Ani Balmanoukian         
Los Angeles Hematology/Oncology Medical Group LA Cancer Network Recruiting
Los Angeles, California, United States, 90017
Contact: Krystal Griffith    310-989-7757    kgriffith@scoranet.org   
Principal Investigator: Lasika Seneviratne         
Cancer Care Associates Medical Group SC Withdrawn
Redondo Beach, California, United States, 90277
University of California San Francisco Dept. of UCSF Recruiting
San Francisco, California, United States, 94101
Contact: Eddie Sosa    415-855-3673    hdfccc_itr_safety_reporting@cc.ucsf.edu   
Principal Investigator: Matthew Gubens         
St. Joseph's Medical Center SC Not yet recruiting
Stockton, California, United States, 95204
Contact: Sandra Wells    209-461-5370    sandra.wells@dignityhealth.org   
Principal Investigator: Ajithkumar Puthillath         
Granada Hills Cancer Center Dept of Oncology Withdrawn
Valencia, California, United States, 91355
United States, Colorado
University of Colorado Univ CO Withdrawn
Aurora, Colorado, United States, 80045
VA Medical Center of Denver SC Recruiting
Denver, Colorado, United States, 80220
Contact: Stephen Barltett    303-399-8020 ext 3865    stephen.bartlett2@va.gov   
Principal Investigator: Daniel Bowles         
Rocky Mountain Cancer Centers RMCC - LoneTree (Sky Ridge) Recruiting
Greenwood Village, Colorado, United States
Contact: Terrence Ogletree    303-925-0700    terrence.ogletree@usoncology.com   
Principal Investigator: Robert M. Jotte         
United States, Connecticut
St. Francis Hospital and Medical Center Recruiting
Hartford, Connecticut, United States, 06105-2000
Contact: Lynn Sperini    860-714-5449    lsperini@stfranciscare.org   
Principal Investigator: James Vredenburg         
Yale University School of Medicine SC Withdrawn
New Haven, Connecticut, United States, 06520
United States, District of Columbia
Georgetown University/Lombardi Cancer Center Dept of Oncology Recruiting
Washington, District of Columbia, United States, 20007-2197
Contact: Rebecca Eberle    202-687-5791    ree28@georgetown.edu   
Principal Investigator: Giuseppe Giaccone         
United States, Florida
Cancer Specialists of North Florida Recruiting
Jacksonville, Florida, United States, 32256
Contact: Carol Starr    904-538-3667    carol.starr@csnf.us   
Principal Investigator: Safeer Ashraf         
University of Miami SC Recruiting
Miami, Florida, United States, 33136
Contact: Lori Kronish    305-243-4624    lkronish@med.miami.edu   
Principal Investigator: Israel Wiznitzer         
Florida Cancer Institute SC Recruiting
New Port Richey, Florida, United States, 34655
Contact: Jane Crofton    407-303-2091    Jane.Crofton@flhosp.org   
Principal Investigator: Tarek Mekhail         
Memorial Cancer Institute Dept of Oncology Recruiting
Pembroke Pines, Florida, United States, 33028
Contact: Janika San Roman    954-844-9917    jsanroman@mhs.net   
Principal Investigator: Luis E. Raez         
United States, Georgia
University Cancer & Blood Center, LLC Dept.of NE GCC Withdrawn
Athens, Georgia, United States, 30607
United States, Hawaii
Kaiser Permanente Hawaii SC Recruiting
Honolulu, Hawaii, United States, 96817
Contact: Shelley Clark       Shelley.a.clark@kp.org   
Principal Investigator: Jennifer Carney         
United States, Illinois
University of Chicago Medical Center SC Recruiting
Chicago, Illinois, United States, 60546
Contact: Michelle Rainer    773-834-0783    mrainer@bsd.uchicago.edu   
Principal Investigator: Ravi Salgia         
Loyola University Medical Center /Cardinal Bernardin Cancer SC Recruiting
Maywood, Illinois, United States, 60153
Contact: Ashish Thakkar    708-327-3222    athakkar3@luc.edu   
Principal Investigator: Kathy Albain         
United States, Indiana
Indiana University Health Goshen Center for Cancer SC Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Matthew Burns    317-278-4712    matburns@iupui.edu   
Principal Investigator: Shadia Jalal         
United States, Iowa
University of Iowa Hospitals & Clinics Oncology Recruiting
Iowa City, Iowa, United States, 52242
Contact: Marian Andersen    319-356-2324    Marian-andersen@uiowa.edu   
Principal Investigator: Taher AbuHejleh         
United States, Kansas
Cancer Center of Kansas Dept of CCK Recruiting
Wichita, Kansas, United States, 67214-3728
Contact: Cheryl Freeman    316-613-4314    cheryl.freeman@cancercenterofkansas.com   
Principal Investigator: Shaker R. Dakhil         
United States, Louisiana
Hematology Oncology Clinic SC Recruiting
Baton Rouge, Louisiana, United States, 70808
Contact: Kathleen Probst    225-761-3951    kprobst@hoc.brcoxmail.com   
Principal Investigator: Michael Castine III         
United States, Maryland
University of Maryland Medical Center SC -1 Recruiting
Baltimore, Maryland, United States, 21201
Contact: Rachel Levy    410-328-5009    rlevy@umm.edu   
Principal Investigator: Josephine Feliciano         
United States, Massachusetts
Massachusetts General Hospital SC-8 Recruiting
Boston, Massachusetts, United States, 02114
Contact: Allison Charles    617-724-1223    acharles5@partners.org   
Principal Investigator: Alice Shaw         
United States, Michigan
University of Michigan Comprehensive Cancer Center Dept of Onc Recruiting
Ann Arbor, Michigan, United States, 48109-0944
Contact: Nicholas Schiavo    734-615-3137    nschiavo@med.umich.edu   
Principal Investigator: Gergory P. Kalemkerian         
Henry Ford Hospital Dept. of Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202-2689
Contact: Carol Monroe    313-916-1784    Cmonroe1@hfhs.org   
Principal Investigator: Thomas Doyle         
United States, Missouri
Mercy Medical Research Institute SC-1 Recruiting
Manchester, Missouri, United States, 63021
Contact: Pearlena Hamlet    417-820-4587    pearlena.hamlet@mercy.net   
Principal Investigator: Viran R. Holden         
United States, New York
Queens Medical Associates, PC SC Recruiting
Fresh Meadows, New York, United States, 11365
Contact: Karen Eisenberg    718-460-2300 ext 3446    keisenberg@queensmedical.com   
Principal Investigator: Gabriel Jung         
Clinical Research Alliance Recruiting
Lake Success, New York, United States, 11042
Contact: Victoria Maresca-Travers    855-737-2873 ext 183    vtravers@researchcra.com   
Principal Investigator: Morton Coleman         
NYU Langone Arena Oncology Clinical Research Alliance Recruiting
Lake Success, New York, United States, 11042
Contact: Brittney McLoughlin    855-737-2873 ext 183    bmclauglin@researchcra.com   
Principal Investigator: Francis Arena         
North Shore University Hospital Dept of Oncology Withdrawn
Manhasset, New York, United States, 10030
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Christine Andan    212-305-0787 ext 7889    cia2104@columbia.edu   
Principal Investigator: Balazs Halmos         
University of Rochester MC / James P. Wilmot Cancer Center Rochester M.C. JP Wimot C Ctr. Recruiting
Rochester, New York, United States, 14642
Contact: Melissa Worman    585-275-3351    Melissa_worman@urmc.rochester.edu   
Principal Investigator: Eric Kim         
SUNY - Upstate Medical University SC Withdrawn
Syracuse, New York, United States, 13210
United States, North Carolina
Levine Cancer Institute Dept of Oncology Withdrawn
Charlotte, North Carolina, United States, 28203
United States, Ohio
Ohio State Comprehensive Cancer Center/James Cancer Hospital SC-3 Recruiting
Columbus, Ohio, United States, 43210
Contact: Caitlin Spontelli    614-366-7421    caitlin.spontelli@osumc.edu   
Principal Investigator: Gregory H. Otterson         
United States, Oklahoma
Tulsa Cancer Institute SC-2 Recruiting
Tulsa, Oklahoma, United States, 74136
Contact: Jolee Holt    918-499-2000    Jolee.holt@tciok.org   
Principal Investigator: Ali Moussa         
United States, Oregon
Providence Cancer Center SC Withdrawn
Portland, Oregon, United States, 97213
United States, Pennsylvania
Fox Chase Cancer Center Fox Chase Cancer (2) Withdrawn
Philadelphia, Pennsylvania, United States, 19111-2497
United States, Rhode Island
Memorial Hospital of Rhode Island SC Withdrawn
Pawtucket, Rhode Island, United States, 02860
United States, South Dakota
Avera Research Institute SC Recruiting
Sioux Falls, South Dakota, United States, 57105
Contact: Sandra Alexander    605-322-3293    sandra.alexander@carolinashealthcare.org   
Principal Investigator: Mark Huber         
United States, Tennessee
The West Clinic SC-2 Recruiting
Memphis, Tennessee, United States, 38120
Contact: Amy Lange    901-683-0055 ext 1236    alange@acornresearch.net   
Principal Investigator: Moon Fenton         
Vanderbilt University Medical Center SC - 7 Recruiting
Nashville, Tennessee, United States, 37232
Contact: Hansel Newman    615-875-0060    hansel.newman@vanderbilt.edu   
Principal Investigator: Leora Horn         
Sarah Cannon Research Institute SC-5 Recruiting
Nashville, Tennessee, United States, 37203
Contact: Emily Angarole    615-329-7274    Emily.angarole@scresearch.net   
Principal Investigator: David R. Spigel         
United States, Texas
US Oncology Central Monitoring Withdrawn
Dallas, Texas, United States, 75246
The Center for Cancer and Blood Disorders SC Withdrawn
Fort Worth, Texas, United States, 76104
Methodist Hospital / Methodist Cancer Center SC Withdrawn
Houston, Texas, United States, 77030
Richardson Hematology Oncology Associates Recruiting
Richardson, Texas, United States, 75082
Contact: Chrystal Miles    214-947-1284    chrystalmiles@mhd.com   
Principal Investigator: Alan Trumbly         
Texas Oncology-Sugarland Recruiting
Sugarland, Texas, United States, 77479
Principal Investigator: Caesar Tin-U         
Texas Oncology Cancer Care & Research Center Recruiting
Waco, Texas, United States, 76712
Contact: Megan Graham    254-399-0741    megan.graham@mckesson.com   
Principal Investigator: Carl Chakmakjian         
United States, Virginia
Virginia Cancer Specialists, PC SC Virginia Cancer Specialists Recruiting
Fairfax, Virginia, United States, 22031
Contact: Janine E. Prime    703-208-3174    janine.prime@usoncology.com   
Principal Investigator: Alexander Spira         
VCU Massey Cancer Center SC Recruiting
Richmond, Virginia, United States, 23298
Contact: Amber C. Hendrix    804-628-0616    hendrixal@vcu.edu   
Principal Investigator: Sherman Baker         
United States, Washington
Swedish Cancer Institute SC-1 Recruiting
Seattle, Washington, United States, 98104
Contact: Erin Shaw    206-386-2443    erin.shaw@swedish.org   
Principal Investigator: Howard L. West         
Wenatchee Valley Medical Center SC Recruiting
Wenatchee, Washington, United States, 98801
Contact: Jessica Stabler    509-665-5800 ext 5014    Jessica.Stabler@McKesson.com   
Principal Investigator: Mitchell Garrison         
United States, Wisconsin
Aurora Advanced Healthcare SC Withdrawn
Milwaukee, Wisconsin, United States, 53215
Medical College of Wisconsin SC Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Virginia Katzke    414-805-5692    vkatzke@mcw.edu   
Principal Investigator: Rafeal Santana-Davila         
Belgium
Novartis Investigative Site Recruiting
Bruxelles, Belgium, 1000
Novartis Investigative Site Not yet recruiting
Bruxelles, Belgium, 1200
Novartis Investigative Site Recruiting
Edegem, Belgium, 2650
Novartis Investigative Site Not yet recruiting
Leuven, Belgium, 3000
Novartis Investigative Site Not yet recruiting
Luxembourg, Belgium, 1210
Canada, Ontario
Novartis Investigative Site Recruiting
Toronto, Ontario, Canada, M5G 1Z6
France
Novartis Investigative Site Recruiting
Besancon cedex, France, 25030
Novartis Investigative Site Recruiting
Brest, France, 29200
Novartis Investigative Site Recruiting
Caen Cedex, France, 14021
Novartis Investigative Site Withdrawn
Creteil, France, 94000
Novartis Investigative Site Recruiting
La Seyne sur mer, France, 83500
Novartis Investigative Site Recruiting
Le Mans Cedex 09, France, 72037
Novartis Investigative Site Recruiting
Lille Cedex, France, 59020
Novartis Investigative Site Withdrawn
Lyon Cedex, France, 69373
Novartis Investigative Site Withdrawn
Mantes la jolie, France, 78201
Novartis Investigative Site Recruiting
Marseille cedex 20, France, 13915
Novartis Investigative Site Not yet recruiting
Montpellier, France, 34059
Novartis Investigative Site Recruiting
Mulhouse cedex, France, 68070
Novartis Investigative Site Withdrawn
Nice Cedex 2, France, 06189
Novartis Investigative Site Recruiting
Paris, France, 75970
Novartis Investigative Site Recruiting
Paris, France, 75015
Novartis Investigative Site Recruiting
Poitiers, France, 86000
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Strasbourg, France, F-67085
Novartis Investigative Site Recruiting
Suresnes, France, 92150
Germany
Novartis Investigative Site Recruiting
Bad Berka, Germany, 99437
Novartis Investigative Site Recruiting
Berlin, Germany, 13125
Novartis Investigative Site Withdrawn
Dresden, Germany, 01307
Novartis Investigative Site Recruiting
Essen, Germany, 45147
Novartis Investigative Site Recruiting
Esslingen, Germany, 73730
Novartis Investigative Site Recruiting
Frankfurt, Germany, 60590
Novartis Investigative Site Recruiting
Grosshansdorf, Germany, 22947
Novartis Investigative Site Recruiting
Heidelberg, Germany, 69120
Novartis Investigative Site Not yet recruiting
Koeln, Germany, 51109
Novartis Investigative Site Recruiting
Oldenburg, Germany, 26121
Novartis Investigative Site Not yet recruiting
Tuebingen, Germany, 72076
Novartis Investigative Site Recruiting
Ulm, Germany, 89081
Hong Kong
Novartis Investigative Site Recruiting
Hong Kong, Hong Kong
Ireland
Novartis Investigative Site Recruiting
Limerick, Co Limerick, Ireland
Novartis Investigative Site Recruiting
Dublin 4, Ireland
Israel
Novartis Investigative Site Recruiting
Kfar-Sava, Israel, 44281
Novartis Investigative Site Not yet recruiting
Petach Tikva, Israel, 49100
Novartis Investigative Site Recruiting
Ramat Gan, Israel, 52621
Italy
Novartis Investigative Site Recruiting
Avellino, AV, Italy, 83100
Novartis Investigative Site Not yet recruiting
Genova, GE, Italy, 16132
Novartis Investigative Site Recruiting
Monza, MB, Italy, 20900
Novartis Investigative Site Not yet recruiting
Milano, MI, Italy, 20132
Novartis Investigative Site Recruiting
Perugia, PG, Italy, 06129
Novartis Investigative Site Not yet recruiting
Pisa, PI, Italy, 56124
Novartis Investigative Site Not yet recruiting
Aviano, PN, Italy, 33081
Novartis Investigative Site Recruiting
Reggio Emilia, RE, Italy, 42123
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Roma, RM, Italy, 00189
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Orbassano, TO, Italy, 10043
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Verona, VR, Italy, 37126
Japan
Novartis Investigative Site Recruiting
Nagoya, Aichi, Japan, 464-8681
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Kashiwa, Chiba, Japan
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Fukuoka-city, Fukuoka, Japan, 812-8582
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Akashi, Hyogo, Japan, 673-8558
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Niigata-city, Niigata, Japan, 951-8520
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Okayama-city, Okayama, Japan, 700-8558
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Hirakata-city, Osaka, Japan, 573-1191
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OsakaSayama, Osaka, Japan, 589-8511
Novartis Investigative Site Recruiting
Takatsuki, Osaka, Japan, 569-8686
Novartis Investigative Site Withdrawn
Sunto-gun, Shizuoka, Japan, 411-8777
Novartis Investigative Site Withdrawn
Chuo-ku, Tokyo, Japan
Novartis Investigative Site Recruiting
Koto, Tokyo, Japan, 135-8550
Novartis Investigative Site Recruiting
Fukuoka, Japan, 811-1395
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Osaka, Japan, 537-8511
Korea, Republic of
Novartis Investigative Site Recruiting
Seoul, Korea, Korea, Republic of, 135-710
Novartis Investigative Site Recruiting
Seoul, Korea, Korea, Republic of, 110 744
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Seoul, Korea, Korea, Republic of, 120-752
Novartis Investigative Site Recruiting
Seoul, Korea, Republic of, 738-736
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Seoul, Korea, Republic of, 137-701
Netherlands
Novartis Investigative Site Recruiting
Amsterdam, Netherlands, 1081 HV
Novartis Investigative Site Recruiting
Groningen, Netherlands, 9713 GZ
Novartis Investigative Site Recruiting
Maastricht, Netherlands, 6229 HX
Russian Federation
Novartis Investigative Site Not yet recruiting
Moscow, Russian Federation, 143423
Novartis Investigative Site Not yet recruiting
Moscow, Russian Federation, 115478
Novartis Investigative Site Not yet recruiting
Murmansk, Russian Federation, 183000
Novartis Investigative Site Not yet recruiting
Sankt-Peterburg, Russian Federation, 197022
Singapore
Novartis Investigative Site Recruiting
Singapore, Singapore, 169610
Novartis Investigative Site Recruiting
Singapore, Singapore, 119228
Spain
Novartis Investigative Site Recruiting
Sevilla, Andalucia, Spain, 41017
Novartis Investigative Site Recruiting
Sevilla, Andalucia, Spain, 41013
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Sabadell, Barcelona, Spain, 08208
Novartis Investigative Site Recruiting
Barcelona, Catalunya, Spain, 08035
Novartis Investigative Site Recruiting
Hospitalet de LLobregat, Catalunya, Spain, 08907
Novartis Investigative Site Not yet recruiting
Barcelona, Cataluña, Spain, 08028
Novartis Investigative Site Recruiting
Valencia, Comunidad Valenciana, Spain, 46010
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La Coruna, Galicia, Spain, 15006
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Santiago de Compostela, Galicia, Spain, 15706
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Majadanonda, Madrid, Spain, 28220
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Madrid, Spain, 28041
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Madrid, Spain, 28034
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Madrid, Spain, 28046
Switzerland
Novartis Investigative Site Recruiting
Luzern, Switzerland, 6000
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St. Gallen, Switzerland, 9007
Turkey
Novartis Investigative Site Recruiting
Ankara, Turkey, 06100
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Istanbul, Turkey, 34303
Novartis Investigative Site Recruiting
Pendik / Istanbul, Turkey, 1330
United Kingdom
Novartis Investigative Site Recruiting
Cheltenham, Gloucestershire, United Kingdom, GL53 7AN
Novartis Investigative Site Recruiting
Hants, Southampton, United Kingdom, SO9 5NY
Novartis Investigative Site Recruiting
Aberdeen, United Kingdom, AB25 2ZN
Novartis Investigative Site Withdrawn
Huddersfield, United Kingdom, HD3 3EA
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 2BX
Novartis Investigative Site Withdrawn
Wolverhampton, United Kingdom, WV10 0QP
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: NCT01828112     History of Changes
Other Study ID Numbers: CLDK378A2303, 2012-005637-36
Study First Received: April 2, 2013
Last Updated: June 23, 2014
Health Authority: United States: Food and Drug Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Canada: Canadian Health Authorities
France: Haute Autorité de Santé Transparency Commission
Germany: Federal Institute for Drugs and Medical Devices
Hong Kong: Department of Health (DoH), pharmaceutical services
Ireland:
Isreal: Ministry of Health
Italy: Ministry of Health
Japan: Ministry of Health, Labor and Welfare
Netherlands: Medicines Evaluation Board (MEB)
Russia:Ministry of Public Health of Russian Federation
Singapore: Health Sciences Authority
South Korea: Korea Food and Drug Administration (KFDA)
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
Switzerland: Swissmedic
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Portugal: Ethics Committee for Clinical Research
Luxembourg: Ministère de la Santé

Keywords provided by Novartis:
Non-Small Cell Lung Cancer, ALK, LDK378

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
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 19, 2014