Study Comparing the Efficacy of MEK162 Versus Dacarbazine in Unresectable or Metastatic NRAS Mutation-positive Melanoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01763164
First received: January 4, 2013
Last updated: May 23, 2014
Last verified: May 2014
  Purpose

Two-arm, randomized, prospective, open-label, multi-center, phase III study to compare the efficacy and safety of MEK162 (45 mg BID) versus dacarbazine (1000 mg/m2 IV every 3 weeks) in patients with advanced (Stage IIIC) unresectable or metastatic (Stage IV) NRAS Q61 mutation-positive cutaneous or unknown primary melanoma. The mutation analysis will be performed at a central laboratory. Only those patients with Q61 mutation per central laboratory and meet all eligibility criteria will be randomized. A total of 393 patients will be randomized 2:1 to receive either MEK162 or dacarbazine. Patients will be stratified according to AJCC stage (IIIC, IVM1a, and IVM1b versus IVM1c), ECOG Performance status (0 versus 1) and any prior number of lines of immunotherapy (immunotherapies versus none). This study will use an Interactive Response Technology (IRT). The primary end point of the study is progression-free survival. Key secondary end point is overall survival


Condition Intervention Phase
Metastatic or Unresectable Cutaneous Melanoma
Drug: MEK162
Drug: Dacarbazine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Phase III, Open Label, Multicenter, Two-arm Study Comparing the Efficacy of MEK162 Versus Dacarbazine in Patients With Advanced Unresectable or Metastatic NRAS Mutation-positive Melanoma

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Progression free survival (PFS) [ Time Frame: The final PFS analysis is expected approximately 16 months after FPFV. ] [ Designated as safety issue: No ]
    PFS is defined as the time from the date of randomization to the date of the first documented disease progression or death due to any cause, whichever occurs first. PFS will be determined by a Blinded Independent Review Committee (BIRC). The local Investigator's assessments will be used as supportive analyses.


Secondary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: Final analysis is expected to occur 21 months after FPFV ] [ Designated as safety issue: No ]
    To compare OS between treatment arms. OS is calculated as the time from date of randomization to date of death due to any cause.

  • Overall Response Rate (ORR) [ Time Frame: Approximately 16 months after the FPFV ] [ Designated as safety issue: No ]
    ORR calculated as the proportion of patient with a best overall response of complete response (CR) or partial response (PR). ORR will be calculated for confirmed and unconfirmed responses separately.

  • Time to Objective Response (TTR) [ Time Frame: Approximately 16 months after the FPFV ] [ Designated as safety issue: No ]
    TTR calculated as the time from date of randomization until first documented complete response (CR) or partial response(PR).

  • Duration of objective response (DOR) [ Time Frame: Approximately 16 months after the FPFV ] [ Designated as safety issue: No ]
    DOR calculated as the time from the date of first documented CR or PR to the first documented progression or death due to underlying cancer

  • Disease control rate (DCR) [ Time Frame: Approximately 16 months after the FPFV ] [ Designated as safety issue: No ]
    DCR calculated as the proportion of patient with a best overall response of CR, PR or stable disease (SD)

  • Number of patients with adverse events [ Time Frame: Approximately 16 months after the FPFV ] [ Designated as safety issue: Yes ]
    To assess the safety and tolerability of MEK162 in this patient, changes in hematology and chemistry values, vital signs, electrocardiograms (ECGs), MUGA(Multi Gated Acquisition Scan)/echocardiogram and assessment of physical and ocular examinations graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03

  • Number of patients with serious adverse events [ Time Frame: Approximately 16 months after the FPFV ] [ Designated as safety issue: Yes ]
    To assess the safety and tolerability of MEK162 in this patient, changes in hematology and chemistry values, vital signs, ECGs, MUGA/echocardiogram and assessment of physical and ocular examinations graded according to the NCI CTCAE v4.03

  • Time to definitive 10% deterioration in the global health status score of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) [ Time Frame: Approximately 16 months after the FPFV ] [ Designated as safety issue: No ]
    To compare the global health status between the treatments.

  • Change from baseline in the global health status score of the EORTC QLQ-C30 [ Time Frame: Approximately 16 months after the FPFV ] [ Designated as safety issue: No ]
    To compare the global health status between the treatment.

  • Change from baseline in the EQ-5D-5L (EuroQol Group standardised instrument for use as a measure of health outcome) [ Time Frame: Approximately 16 months after the FPFV ] [ Designated as safety issue: No ]
    To compare the global health status between the treatment.


Estimated Enrollment: 393
Study Start Date: July 2013
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MEK162 Drug: MEK162
MEK162 will be administered as a fixed dose of 45 mg (3 x 15 mg tablets) BID, with a glass of water and taken with or without food.
Active Comparator: Dacarbazine Drug: Dacarbazine
Patients randomized to dacarbazine will receive an IV infusion of dacarbazine 1000 mg/m2 over the course of 1 hour on day 1 and then every three weeks.

  Eligibility

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

Inclusion Criteria:

  • Diagnosis of locally advanced, unresectable or metastatic cutaneous or melanoma of unknown primary AJCC Stage IIIC or IV (uveal and mucosal melanoma are excluded)
  • Presence of NRAS Q61 mutation in tumor tissue prior to randomization as determined by a Novartis designated central laboratory
  • Naïve untreated patients or patients who have progressed on or after any number of prior lines of immunotherapy for unresectable locally advanced or metastatic melanoma
  • Evidence of at least one measurable lesion as detected by radiological or photographic methods
  • Adequate bone marrow, organ function, cardiac and laboratory parameters
  • Normal functioning of daily living activities

Exclusion Criteria:

  • Any untreated CNS metastases
  • Uveal or mucosal melanoma
  • History of or current evidence of retinal vein occlusion (RVO) or risk factors of RVO
  • Patients with washout period < 6 weeks from the last dose of ipilimumab or other immunotherapy.
  • Previous chemotherapy for unresectable locally advanced or metastatic melanoma.
  • History of Gilbert's syndrome
  • Prior therapy with a MEK- inhibitor
  • Impaired cardiovascular function or clinically significant cardiovascular diseases
  • Uncontrolled arterial hypertension despite medical treatment
  • HIV positive or active Hepatitis A or B
  • Impairment of gastrointestinal function
  • Patients who have undergone major surgery or radiotherapy ≤ 3 weeks prior to starting study drug or who have not recovered from side effects of such procedure;
  • Patients with neuromuscular disorders that are associated with elevated CK.
  • Pregnant or nursing (lactating) women
  • Medical, psychiatric, cognitive or other conditions that may compromise the patient's ability to understand the patient information, give informed consent, comply with the study protocol or complete the study

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: NCT01763164

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

  Hide Study Locations
Locations
United States, Alabama
University of South Alabama / Mitchell Cancer Institute SC Recruiting
Mobile, Alabama, United States, 36688
Contact: Melanie Alford    251-445-9649    malford@health.southalabama.edu   
Principal Investigator: Thomas Butler         
United States, Arkansas
Highlands Oncology Group SC Recruiting
Fayetteville, Arkansas, United States, 72703
Contact: Angela R. Stewart    479-872-8130    dlatham@hogonc.com   
Principal Investigator: Joseph T. Beck         
United States, California
Beverly Hills Cancer Center SC Not yet recruiting
Beverly HIlls, California, United States, 90211
Contact: Audrey Zeh    310-432-8932    azeh@bhcancercenter.com   
Principal Investigator: Steven O'Day         
USC/Kenneth Norris Comprehensive Cancer Center Not yet recruiting
Los Angeles, California, United States, 90033
Contact: Gina Tse    323-865-0460    Tse_G@ccnt.hsc.usc.edu   
Principal Investigator: Michael K. Wong         
California Pacific Medical Center SC Not yet recruiting
San Francisco, California, United States, 94115
Contact: Laura Fiske    415-600-1654    FiskeL@cpmcri.org   
Principal Investigator: David Minor         
Stanford University Medical Center SC - 3 Recruiting
Stanford, California, United States, 94304
Contact: Mitra Kristanion    650-723-0371    mitrak@stanford.edu   
Principal Investigator: Branimir Sikic         
United States, Colorado
University of Colorado Dept of Oncology Withdrawn
Aurora, Colorado, United States, 80045
United States, District of Columbia
Georgetown University/Lombardi Cancer Center SC Not yet recruiting
Washington, District of Columbia, United States, 20007-2197
Contact: Sampada Apte    202-687-2111    Ska38@georgetown.edu   
Principal Investigator: Michael Atkins         
United States, Florida
Florida Cancer Specialists Dept of Onc Recruiting
Fort Myers, Florida, United States, 33901
Contact: Tricia K. Sheppard    727-216-1143    tsheppard@flcancer.com   
Principal Investigator: David D. Wright         
Florida Cancer Specialists SC Recruiting
Fort Myers, Florida, United States, 33901
Contact: Susan A. Samies         
Principal Investigator: James Reeves         
Palm Beach Cancer Institute SC-2 Withdrawn
West Palm Beach, Florida, United States, 33401
United States, Illinois
Oncology Specialists, SC SC - 5 Recruiting
Park Ridge, Illinois, United States, 60068-0736
Contact: Milenna Undda    847-268-8200    mundda@oncmed.net   
Principal Investigator: Sigrun Hallmeyer         
United States, Indiana
Indiana University Health Goshen Center for Cancer SC Recruiting
Goshen, Indiana, United States, 46526
Contact: Toni Morgan    574-364-2974    amorgan13@iuhealth.org   
Principal Investigator: Alexander N. Starodub         
United States, Iowa
University of Iowa Hospitals & Clinics Oncology Withdrawn
Iowa City, Iowa, United States, 52242
United States, Maine
Eastern Maine Medical Center Research Center SC Recruiting
Bangor, Maine, United States, 04401
Contact: Teresa White    207-973-4249    twhite@emhs.org   
Principal Investigator: Sigrid E. Berg         
United States, Maryland
Weinberg Cancer Institute at Franklin Square Hospital Dept of Oncology Recruiting
Baltimore, Maryland, United States, 21237-3998
Contact: Janice Fowler    443-777-7458    Janice.fowler@medstar.net   
Principal Investigator: Pallavi P Kumar         
United States, Massachusetts
Massachusetts General Hospital SC -6 Recruiting
Boston, Massachusetts, United States, 02114
Contact: Alicia Barlow    617-643-5470    Asbarlow@partners.org   
Principal Investigator: Keith T. Flaherty         
United States, Michigan
Wayne State University/Karmanos Cancer Institute SC - 1 Recruiting
Detroit, Michigan, United States, 48201
Contact: Cynthia Marsack    313-576-8394    elizabethmiller@radiantresearch.com   
Principal Investigator: Lawrence Flaherty         
Mercy Health Saint Mary's SC-2 Not yet recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Kathleen Estowski       estkowk@mercyhealth.com   
Principal Investigator: Thomas Gribbin         
United States, Minnesota
University of Minnesota Medical Center SC Not yet recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Darlette Luke    612-626-2569    dluke1@fairview.org   
Principal Investigator: Venkatesh Rudrapatna         
Minnesota Oncology Hematology, P.A. Fridley Location Recruiting
Minneapolis, Minnesota, United States, 55404
Contact: Lynn Anderson    763-252-1718    lynn.anderson@usoncology.com   
Principal Investigator: Thomas Amatruda         
United States, Missouri
Mercy Medical Research Institute SC-1 Recruiting
Manchester, Missouri, United States, 63021
Contact: Deborah F Essary    417-820-4587    pearlena.hamlet@mercy.net   
Principal Investigator: Viran R. Holden         
United States, Nebraska
Nebraska Methodist Hospital Estabrook Cancer Center Recruiting
Omaha, Nebraska, United States, 68114
Contact: Jodi Parziale    402-354-8250    jodi.parziale@nmhs.org   
Principal Investigator: Ralph Hauke         
United States, Nevada
Comprehensive Cancer Centers of Nevada CCC of Nevada (1) Recruiting
Las Vegas, Nevada, United States, 89109
Contact: Edwin C. Kingsley    702-952-3426    robert.bimbi@usoncology.com   
Principal Investigator: Wolfram Samlowski         
United States, New Hampshire
Dartmouth Hitchcock Medical Center SC - 1 Not yet recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Bridget Labrie    603-650-4035    Bridget.m.labrie@hitchcock.org   
Principal Investigator: Marc S. Ernstoff         
United States, New Jersey
Cooper Cancer Center SC Recruiting
Camden, New Jersey, United States, 08103
Contact: Art Lederman    856-673-4908    Lederman-art@cooperhealth.edu   
Principal Investigator: Nati Lerman         
Hackensack University Medical Center SC-2 Not yet recruiting
Hackensack, New Jersey, United States, 07601
Contact: Renee Lomelino    551-996-5809    RLomelino@HackensackUMC.org   
Principal Investigator: Andrew L. Pecora         
United States, New York
Memorial Sloan Kettering Cancer Center Dept Oncology Not yet recruiting
New York, New York, United States, 10021
Contact: Natasha Martin    646-888-4339    martinn@mskcc.org   
Principal Investigator: Gary K. Schwartz         
United States, North Carolina
Duke University Medical Center SC-6 Withdrawn
Durham, North Carolina, United States, 27710
United States, Ohio
Ohio State Comprehensive Cancer Center/James Cancer Hospital Ohio State University Not yet recruiting
Columbus, Ohio, United States, 43210
Contact: Caitlin Spontelli    614-293-2268    caitlin.spontelli@osumc.edu   
Principal Investigator: Kari L. Kendra         
United States, Oregon
Oregon Health & Science University SC-7 Recruiting
Portland, Oregon, United States, 97239
Contact: Kendra Todd    503-418-8168    koeneman@ohsu.edu   
Principal Investigator: Matthew Taylor         
Kaiser Permanente Northwest Dept of Kaiser Northwest (3) Recruiting
Portland, Oregon, United States, 97227
Contact: Gayla Curl    503-249-3317    gayla.d.curl@kp.org   
Principal Investigator: Mark U Rarick         
Northwest Cancer Specialists Compass Oncology - SC Recruiting
Portland, Oregon, United States, 97210
Contact: Susan Papenfuse    360-597-1358    susan.papenfuse@usoncology.com   
Principal Investigator: John Smith,II         
United States, Pennsylvania
St. Luke's Hospital and Health Network SC Not yet recruiting
Bethlehem, Pennsylvania, United States
Contact: Jayne Silva    484-503-4151    silvaj@slhn.org   
Principal Investigator: Sanjiv S. Agarwala         
Penn State University / Milton S. Hershey Medical Center SC-2 Recruiting
Hershey, Pennsylvania, United States, 17033-0850
Contact: Cynthia A. DuBrock    717-531-6585    cdubrock@psu.edu   
Principal Investigator: Rogerio I. Neves         
Thomas Jerfferson University Hospital SC Recruiting
Philadelphia, Pennsylvania, United States, 19107-5098
Contact: Shingo Sato    215-955-9980    shingo.sato@jefferson.edu   
Principal Investigator: Kendra Feeney         
University of Pennsylvania Medical Center SC - 2 Recruiting
Philadephia, Pennsylvania, United States, 19104
Contact: Amy Marshall    215-662-2190    Amy.marshall@uphs.upenn.edu   
Principal Investigator: Ravi Amaravadi         
University of Pittsburgh Medical Center SC-4 Recruiting
Pittsburgh, Pennsylvania, United States
Contact: Michelle Merriman    412-623-6121    merrimanmi@upmc.edu   
Principal Investigator: Ahmad Tarhini         
United States, Tennessee
Sarah Cannon Research Institute SC - 2 Recruiting
Nashville, Tennessee, United States, 37203
Contact: Lisa G Simons    615-329-7413    Lisa.Simons@scresearch.net   
Principal Investigator: Jeffrey R. Infante         
United States, Texas
US Oncology Central Monitoring Withdrawn
Dallas, Texas, United States, 75246
Baylor Health Care System/Sammons Cancer Center Oncology Recruiting
Dallas, Texas, United States, 75246
Contact: Denise Kelley    214-818-8471    denise.kelley@usoncology.com   
Principal Investigator: Charles L Cowey         
University of Texas Southwestern Medical Center SC (5) Recruiting
Dallas, Texas, United States, 75390-8527
Contact: Anne Roberto       anne.roberto@utsouthwestern.edu   
Principal Investigator: Arthur Frankel         
University of Texas Health Science Center at Houston SC Not yet recruiting
Houston, Texas, United States, 77030
Contact: Susan Cooper    832-325-7308    susan.cooper@uth.tmc.edu   
Principal Investigator: Jorge Quesada         
Argentina
Novartis Investigative Site Recruiting
Rosario, Santa Fe, Argentina, S2000KZE
Novartis Investigative Site Recruiting
Rio Negro, Viedma, Argentina, 8500
Novartis Investigative Site Withdrawn
Buenos Aires, Argentina, C1125ABE
Novartis Investigative Site Not yet recruiting
Buenos Aires, Argentina, C1050AAK
Australia, New South Wales
Novartis Investigative Site Not yet recruiting
Camperdown, New South Wales, Australia, 2050
Novartis Investigative Site Recruiting
Gateshead, New South Wales, Australia, 2290
Novartis Investigative Site Recruiting
North Sydney, New South Wales, Australia, 2060
Australia, Queensland
Novartis Investigative Site Recruiting
Woolloongabba, Queensland, Australia, 4102
Australia, South Australia
Novartis Investigative Site Not yet recruiting
Adelaide, South Australia, Australia, 5000
Australia, Western Australia
Novartis Investigative Site Withdrawn
Nedlands, Western Australia, Australia, 6009
Austria
Novartis Investigative Site Recruiting
Graz, Austria, 8036
Novartis Investigative Site Recruiting
Innsbruck, Austria, 6020
Novartis Investigative Site Recruiting
Linz, Austria, A-4010
Novartis Investigative Site Recruiting
Salzburg, Austria, 5020
Novartis Investigative Site Recruiting
Wien, Austria, A-1090
Belgium
Novartis Investigative Site Withdrawn
Gent, Belgium, 9000
Novartis Investigative Site Recruiting
Leuven, Belgium, 3000
Novartis Investigative Site Recruiting
Liege, Belgium, 4000
Novartis Investigative Site Recruiting
Wilrijk, Belgium, 2610
Brazil
Novartis Investigative Site Not yet recruiting
Rio de Janeiro, RJ, Brazil, 20220410
Novartis Investigative Site Not yet recruiting
Passo Fundo, RS, Brazil, 99010-260
Novartis Investigative Site Not yet recruiting
Porto Alegre, RS, Brazil, 90035-903
Novartis Investigative Site Not yet recruiting
Barretos, SP, Brazil, 14784-400
Novartis Investigative Site Not yet recruiting
Jaú, SP, Brazil, 17210-080
Novartis Investigative Site Not yet recruiting
Sao Paulo, SP, Brazil, 01321-001
Canada, Alberta
Novartis Investigative Site Withdrawn
Calgary, Alberta, Canada, T2N 4N2
Novartis Investigative Site Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Ontario
Novartis Investigative Site Recruiting
London, Ontario, Canada, N6A 4L6
Novartis Investigative Site Recruiting
Toronto, Ontario, Canada, M4N 3M5
Novartis Investigative Site Recruiting
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Novartis Investigative Site Withdrawn
Montreal, Quebec, Canada, H2L 4M1
Novartis Investigative Site Recruiting
Montreal, Quebec, Canada, H3T 1E3
Novartis Investigative Site Recruiting
Sainte-Foy, Quebec, Canada, G1V 4T3
Czech Republic
Novartis Investigative Site Recruiting
Brno, Czech Republic, 65653
Novartis Investigative Site Recruiting
Ostrava Poruba, Czech Republic, 708 52
Novartis Investigative Site Recruiting
Praha 10, Czech Republic, 100 34
Novartis Investigative Site Recruiting
Praha 2, Czech Republic, 128 08
France
Novartis Investigative Site Recruiting
Angers, France, 49033
Novartis Investigative Site Recruiting
Bordeaux Cedex, France, 33075
Novartis Investigative Site Not yet recruiting
Boulogne Billancourt, France, 92104
Novartis Investigative Site Recruiting
Le Mans Cedex 09, France, 72037
Novartis Investigative Site Recruiting
LILLE Cedex, France, 59037
Novartis Investigative Site Recruiting
Lyon Cedex, France, 69373
Novartis Investigative Site Recruiting
Marseille Cedex 05, France, 13885
Novartis Investigative Site Withdrawn
Montpellier cedex 5, France, 34295
Novartis Investigative Site Withdrawn
Nantes, France, 44035
Novartis Investigative Site Recruiting
Nice Cedex 3, France, 06202
Novartis Investigative Site Recruiting
Paris, France, 75475
Novartis Investigative Site Recruiting
Pierre-Benite Cedex, France, 69495
Novartis Investigative Site Not yet recruiting
Reims, France, 51092
Novartis Investigative Site Withdrawn
Toulouse Cedex 9, France, 31059
Novartis Investigative Site Withdrawn
Villejuif Cedex, France, 94805
Germany
Novartis Investigative Site Recruiting
Berlin, Germany, 10098
Novartis Investigative Site Recruiting
Dresden, Germany, 01307
Novartis Investigative Site Recruiting
Essen, Germany, 45147
Novartis Investigative Site Not yet recruiting
Frankfurt, Germany, 60590
Novartis Investigative Site Recruiting
Freiburg, Germany, 79106
Novartis Investigative Site Recruiting
Gera, Germany, 07548
Novartis Investigative Site Recruiting
Hannover, Germany, 30625
Novartis Investigative Site Recruiting
Heidelberg, Germany, 69120
Novartis Investigative Site Recruiting
Kiel, Germany, 24105
Novartis Investigative Site Recruiting
Köln, Germany, 50924
Novartis Investigative Site Recruiting
Lübeck, Germany, 23538
Novartis Investigative Site Recruiting
Minden, Germany, 32429
Novartis Investigative Site Recruiting
Muenchen, Germany, 80336
Novartis Investigative Site Recruiting
Muenster, Germany, 48157
Novartis Investigative Site Recruiting
Nuernberg, Germany, 90419
Novartis Investigative Site Recruiting
Quedlinburg, Germany, 06484
Novartis Investigative Site Recruiting
Stade, Germany, 21682
Novartis Investigative Site Recruiting
Tübingen, Germany, 72076
Novartis Investigative Site Recruiting
Ulm, Germany, 89081
Novartis Investigative Site Recruiting
Würzburg, Germany, 97080
Greece
Novartis Investigative Site Not yet recruiting
Athens, GR, Greece, 11527
Hungary
Novartis Investigative Site Recruiting
Budapest, Hungary, 1134
Novartis Investigative Site Not yet recruiting
Budapest, Hungary, H-1122
Novartis Investigative Site Not yet recruiting
Budapest, Hungary, H-1085
Novartis Investigative Site Not yet recruiting
Kaposvar, Hungary, 7400
Novartis Investigative Site Not yet recruiting
Szolnok, Hungary, H-5000
Israel
Novartis Investigative Site Recruiting
Haifa, Israel, 31096
Novartis Investigative Site Recruiting
Jerusalem, Israel, 91120
Novartis Investigative Site Recruiting
Ramat Gan, Israel, 52621
Italy
Novartis Investigative Site Recruiting
Bari, BA, Italy, 70126
Novartis Investigative Site Recruiting
Bergamo, BG, Italy, 24128
Novartis Investigative Site Recruiting
Brescia, BS, Italy, 25123
Novartis Investigative Site Recruiting
Genova, GE, Italy, 16132
Novartis Investigative Site Not yet recruiting
Milano, MI, Italy, 20141
Novartis Investigative Site Not yet recruiting
Milano, MI, Italy, 20133
Novartis Investigative Site Recruiting
Padova, PD, Italy, 35100
Novartis Investigative Site Recruiting
Roma, RM, Italy, 00167
Novartis Investigative Site Recruiting
Roma, RM, Italy, 00128
Novartis Investigative Site Recruiting
Siena, SI, Italy, 53100
Novartis Investigative Site Not yet recruiting
Torino, TO, Italy, 10126
Novartis Investigative Site Recruiting
Napoli, Italy, 80131
Japan
Novartis Investigative Site Not yet recruiting
Fukuoka-city, Fukuoka, Japan, 812-8582
Novartis Investigative Site Recruiting
Matsumoto, Nagano, Japan, 390-8621
Novartis Investigative Site Recruiting
Hirakata-city, Osaka, Japan, 573-1191
Novartis Investigative Site Suspended
Sunto-gun, Shizuoka, Japan, 411-8777
Novartis Investigative Site Recruiting
Chuo-ku, Tokyo, Japan
Korea, Republic of
Novartis Investigative Site Recruiting
Seoul, Korea, Korea, Republic of, 110 744
Novartis Investigative Site Recruiting
Seoul, Korea, Korea, Republic of, 120-752
Novartis Investigative Site Recruiting
Seoul, Korea, Korea, Republic of, 135-710
Novartis Investigative Site Recruiting
Seoul, Korea, Republic of, 738-736
Netherlands
Novartis Investigative Site Recruiting
Amsterdam, Netherlands, 1066 CX
Novartis Investigative Site Recruiting
Leiden, Netherlands, 2300 RC
Novartis Investigative Site Recruiting
Nijmegen, Netherlands, 6525 GA
Novartis Investigative Site Recruiting
Zwolle, Netherlands, 8025 AB
Poland
Novartis Investigative Site Recruiting
Warszawa, Poland, 02-781
Portugal
Novartis Investigative Site Not yet recruiting
Almada, Portugal, 2801-951
Novartis Investigative Site Not yet recruiting
Porto, Portugal, 4200-072
Russian Federation
Novartis Investigative Site Recruiting
Ryazan, Russia, Russian Federation, 390011
Novartis Investigative Site Recruiting
Moscow, Russian Federation, 115478
Novartis Investigative Site Recruiting
St. Petersburg, Russian Federation, 197758
Slovakia
Novartis Investigative Site Recruiting
Bratislava, Slovak Republic, Slovakia, 83310
South Africa
Novartis Investigative Site Recruiting
Bloemfontein, South Africa, 9300
Novartis Investigative Site Recruiting
Johannesburg, South Africa, 2000
Novartis Investigative Site Recruiting
Pretoria, South Africa, 0027
Novartis Investigative Site Recruiting
Pretoria, South Africa, 0002
Spain
Novartis Investigative Site Not yet recruiting
Málaga, Andalucia, Spain, 29010
Novartis Investigative Site Recruiting
Sevilla, Andalucia, Spain, 41009
Novartis Investigative Site Recruiting
Toledo, Castilla la Mancha, Spain, 45004
Novartis Investigative Site Recruiting
Barcelona, Catalunya, Spain, 08036
Novartis Investigative Site Not yet recruiting
Barcelona, Catalunya, Spain, 08035
Novartis Investigative Site Recruiting
Hospitalet de LLobregat, Catalunya, Spain, 08907
Novartis Investigative Site Not yet recruiting
Valencia, Comunidad Valenciana, Spain, 46009
Novartis Investigative Site Recruiting
Badajoz, Extremadura, Spain, 06080
Novartis Investigative Site Recruiting
Las Palmas de Gran Canarias, Las Palmas de Gran Canaria, Spain, 35016
Novartis Investigative Site Recruiting
Pamplona, Navarra, Spain, 31002
Novartis Investigative Site Recruiting
Madrid, Spain, 28033
Novartis Investigative Site Recruiting
Madrid, Spain, 28050
Novartis Investigative Site Recruiting
Madrid, Spain, 28009
Novartis Investigative Site Recruiting
Madrid, Spain, 28040
Sweden
Novartis Investigative Site Withdrawn
Goteborg, Sweden, SE-413 45
Novartis Investigative Site Recruiting
Lund, Sweden, SE-221 85
Novartis Investigative Site Withdrawn
Stockholm, Sweden, SE-171 76
Switzerland
Novartis Investigative Site Recruiting
Genève, Switzerland, 1211
Novartis Investigative Site Recruiting
Lausanne, Switzerland, 1011
Novartis Investigative Site Recruiting
Zürich, Switzerland, 8091
Turkey
Novartis Investigative Site Recruiting
Ankara, Turkey, 06490
Novartis Investigative Site Recruiting
Istanbul, Turkey, 34303
Novartis Investigative Site Recruiting
Izmir, Turkey, 35040
United Kingdom
Novartis Investigative Site Recruiting
Bristol, Avon, United Kingdom, BS2 8ED
Novartis Investigative Site Recruiting
Truro, Cornwall, United Kingdom, TR1 3LJ
Novartis Investigative Site Recruiting
Surrey, England, United Kingdom, GU2 7XX
Novartis Investigative Site Recruiting
Birmingham, Surrey, United Kingdom, B15 2TH
Novartis Investigative Site Recruiting
Leeds, West Yorkshire, United Kingdom, LS9 7TF
Novartis Investigative Site Recruiting
Chelmsford, United Kingdom, CM1 7ET
Novartis Investigative Site Recruiting
Dundee, United Kingdom, DD1 9SY
Novartis Investigative Site Recruiting
London, United Kingdom, SW3 6JJ
Novartis Investigative Site Recruiting
Merseyside, United Kingdom, L63 4JY
Novartis Investigative Site Recruiting
Preston, United Kingdom, PR2 9HT
Novartis Investigative Site Not yet recruiting
Swansea, United Kingdom, SA2 8QA
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: NCT01763164     History of Changes
Other Study ID Numbers: CMEK162A2301, 2012-003593-51
Study First Received: January 4, 2013
Last Updated: May 23, 2014
Health Authority: United States: Food and Drug Administration
Australia: National Health and Medical Research Council
Austria: Agency for Health and Food Safety
Belgium: Federal Agency for Medicinal Products and Health Products
Italy: The Italian Medicines Agency
Argentina: Ministry of Health
Canada: Health Canada
Czech Republic: State Institute for Drug Control
France: Ministry of Health
Germany: Federal Institute for Drugs and Medical Devices
Hungary: Institutional Ethics Committee
Japan: Pharmaceuticals and Medical Devices Agency
Korea: Food and Drug Administration
Netherlands: Medicines Evaluation Board (MEB)
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Russia: Ministry of Health of the Russian Federation
Slovakia: State Institute for Drug Control
South Africa: Medicines Control Council
Spain: Spanish Agency of Medicines
Switzerland: Swissmedic
Turkey: Ministry of Health
Brazil: Ministry of Health
Greece: Ministry of Health and Welfare

Keywords provided by Novartis:
Melanoma
Cutaneous melanoma
Skin disease
Skin cancer
Skin Neoplasms
Neoplasm Metastasis

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Dacarbazine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 31, 2014