A Study of Nilotinib Versus Imatinib in GIST Patients (ENESTg1)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00785785
First received: November 4, 2008
Last updated: March 13, 2014
Last verified: March 2014
  Purpose

This study will evaluate efficacy and safety of nilotinib versus imatinib in adult patients with unresectable or metastatic gastrointestinal stromal tumors (GIST).


Condition Intervention Phase
Gastrointestinal Stromal Tumor (GIST)
Drug: Nilotinib (AMN107)
Drug: imatinib (STI571)
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, Open Label, Multi-center Phase III Study to Evaluate the Efficacy and Safety of Nilotinib Versus Imatinib in Adult Patients With Unresectable or Metastatic Gastrointestinal Stromal Tumors (GIST)

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • To compare Progression Free Survival (PFS) of nilotinib and imatinib when used as initial therapy in patents with unresectable and/ or metastatic GIST. [ Time Frame: throughout the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To compare disease control rate (DCR) of nilotinib and imatinib [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
  • To compare time to treatment failure (TTF) of nilotinib and imatinib [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
  • To compare overall survival (OS) of nilotinib and imatinib [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
  • To compare time to progression (TTP), response rate (RR), time to tumor response and assess duration of response of nilotinib and imatinib [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
  • To compare safety and tolerability of nilotinib and imatinib [ Time Frame: at month 1 and then every 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 736
Study Start Date: March 2009
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nilotinib Drug: Nilotinib (AMN107)
Active Comparator: Imatinib Drug: imatinib (STI571)
Other Name: Glivec/Gleevec

  Eligibility

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

Inclusion Criteria:

  1. Histologically confirmed diagnosis of GIST which is unresectable and/or metastatic and either:

    • have not received any prior anti-neoplastic therapy other than adjuvant imatinib. Note: newly diagnosed patients may have received up to 14 days of treatment with imatinib for disease management while awaiting entry to the study or
    • recurrent GIST after stopping adjuvant treatment with imatinib and no subsequent treatment with any other therapies.
  2. At least one measurable site of disease on CT/MRI scan
  3. Performance status ≤ 2 (capable of self-care but unable to carry out any work)
  4. Normal organ, electrolyte and marrow function

Exclusion Criteria:

  1. Any prior anti-neoplastic therapy with the exception of patients who have received adjuvant imatinib or patients with newly diagnosed metastatic/ unresectable GIST whose disease requires therapy while awaiting entry to the study.
  2. Disease progression during adjuvant therapy with imatinib
  3. History of active malignancy (other than GIST) within 10 years prior to study entry with the exception of previous or concomitant basal cell skin cancer, previous cervical carcinoma in situ.
  4. Impaired cardiac function

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: NCT00785785

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

  Hide Study Locations
Locations
United States, Alabama
Birmingham Hematology and Oncology Associates Terminated
Birmingham, Alabama, United States, 35205
United States, Arizona
Northern Arizona Hematology/Oncology Associates, P.C. Dept. of No. AZ Hem-Onc Active, not recruiting
Flagstaff, Arizona, United States, 86001
United States, Arkansas
Hematology Oncology Services of Arkansas SC Withdrawn
Little Rock, Arkansas, United States, 72205
United States, California
City of Hope National Medical Center Regulatory Document Completed
Duarte, California, United States, 91010-3000
City of Hope National Medical Center Dept.ofCityofHopeMedicalCtr(4) Terminated
Duarte, California, United States, 91010-3000
University of California San Diego Dept of Moores Cancer Ctr (2) Completed
La Jolla, California, United States, 92093-0658
University of California at Los Angeles GI Oncology Program Completed
Los Angeles, California, United States, 90095
Southwest Cancer Care Dept.ofSouthwestCancerCare Withdrawn
Poway, California, United States, 92064
Stanford University Medical Center Stanford Cancer Center Completed
Stanford, California, United States, 94304
United States, Colorado
University of Colorado Dept. of Univ. of Colorado Completed
Aurora, Colorado, United States, 80045
Rocky Mountain Cancer Centers Dept. of Rocky Mountain Cancer Completed
Greenwood Village, Colorado, United States
United States, District of Columbia
Washington Hospital Center Wash Hospital Completed
Washington, District of Columbia, United States, 20010
United States, Florida
Mayo Clinic - Jacksonville Mayo Withdrawn
Jacksonville, Florida, United States, 32224
Ocala Oncology Center Dept. of Ocala Oncology Center Terminated
Ocala, Florida, United States, 34474
United States, Georgia
University Cancer & Blood Center, LLC Dept.of NE GCC Withdrawn
Athens, Georgia, United States, 30607
Emory University School of Medicine/Winship Cancer Institute Dept.ofWinshipCancerInstitute Withdrawn
Atlanta, Georgia, United States, 30322
United States, Idaho
Kootenai Medical Center Dept.ofKootenai Med.Ctr. Completed
Coeur d'Alene, Idaho, United States, 83814
United States, Illinois
Northwestern University Clinical Research Office (2) Completed
Chicago, Illinois, United States, 60611
United States, Iowa
University of Iowa Hospitals & Clinics Dept.ofUniv.of IowaHosp&Clinic Withdrawn
Iowa City, Iowa, United States, 52242
United States, Kansas
University of Kansas Cancer Center DeptofUofKansas CancerCenter-2 Withdrawn
Kansas City, Kansas, United States, 66160
United States, Maryland
Johns Hopkins University Hospital Dept.ofJohnsHopkinsHospital Withdrawn
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Dana Farber Cancer Institute Centerfor Sarcoma&BoneOncology Completed
Boston, Massachusetts, United States, 02115
United States, Michigan
University of Michigan Comprehensive Cancer Center DeptofMichiganCancerCenter(6) Terminated
Ann Arbor, Michigan, United States, 48109-0944
United States, Minnesota
Minnesota Oncology Hematology, P.A. SC Completed
Minneapolis, Minnesota, United States, 55404
Mayo Clinic - Rochester Division of Hematology Completed
Rochester, Minnesota, United States, 55905
United States, New York
Rochester General Hospital / Lipson Cancer Center Lipson Cancer Center (2) Withdrawn
Rochester, New York, United States, 14621
New York Oncology Hematology, P.C. NYOH@AlbanyMedicalCenter(2) Completed
Troy, New York, United States, 12180
New York Oncology Hematology, P.C. NYOH Amsterdam Completed
Troy, New York, United States, 12180
United States, Oregon
Northwest Cancer Specialists Portland Location Withdrawn
Portland, Oregon, United States, 97210
United States, Pennsylvania
St. Luke's Hospital and Health Network St. Luke's Cancer Network (3) Withdrawn
Bethlehem, Pennsylvania, United States
Pennsylvania Oncology/Hemotology Dept.ofPenn. Onc./Hem. Withdrawn
Philadelphia, Pennsylvania, United States, 19106
University of Pennsylvania Medical Center CAMN107G2301 Active, not recruiting
Philadelphia, Pennsylvania, United States, 19104-4283
University of Pittsburgh Medical Center Hillman Cancer Center (3) Withdrawn
Pittsburgh, Pennsylvania, United States
United States, Tennessee
Vanderbilt Univeristy Ingram Cancer Ctr. Completed
Nashville, Tennessee, United States, 37232
United States, Texas
Texas Oncology, P.A. Tex Onc (2) Terminated
Bedford, Texas, United States, 76022
Texas Oncology, P.A. Wichita Falls Completed
Dallas, Texas, United States, 75246
US Oncology Central Monitoring Withdrawn
Dallas, Texas, United States, 75246
University of Texas Southwestern Medical Center DeptofSimmons Cancer Center(3) Completed
Dallas, Texas, United States, 75390-8527
Parkland Health and Hospital Systems Dept.ofParklandHealth&Hospital Withdrawn
Dallas, Texas, United States, 75325
University of Texas/MD Anderson Cancer Center Dept. of MD Anderson (13) Completed
Houston, Texas, United States, 77030-4009
Cancer Care Centers of South Texas / HOAST CCC of So. TX- San Antonio(2) Completed
San Antonio, Texas, United States, 78229
Tyler Cancer Center Dept.ofTylerCancerCtr. (2) Completed
Tyler, Texas, United States, 75702
United States, Utah
University of Utah / Huntsman Cancer Institute Dept.ofHuntsmanCancerInst.(3) Active, not recruiting
Salt Lake City, Utah, United States, 84112
United States, Wisconsin
U of Wisconsin Hospital & Clinics Univ.of Wisconsin CancerCenter Withdrawn
Madison, Wisconsin, United States, 53792
Aurora Advanced Healthcare SC Withdrawn
Milwaukee, Wisconsin, United States, 53215
Argentina
Novartis Investigative Site Completed
Caba, Buenos Aires, Argentina, C1426ANZ
Novartis Investigative Site Completed
Rosario, Santa Fe, Argentina, S2000PBH
Novartis Investigative Site Active, not recruiting
Buenos Aires, Argentina, C1264AAA
Novartis Investigative Site Withdrawn
Neuquén, Argentina, 8300
Austria
Novartis Investigative Site Completed
Graz, Austria, 8036
Novartis Investigative Site Completed
Innsbruck, Austria, 6020
Novartis Investigative Site Completed
Leoben, Austria, A-8700
Novartis Investigative Site Completed
Wels, Austria, 4600
Novartis Investigative Site Completed
Wien, Austria, A-1090
Brazil
Novartis Investigative Site Withdrawn
Salvador, BA, Brazil, 41825-010
Novartis Investigative Site Completed
Uberlândia, MG, Brazil, 38408-150
Novartis Investigative Site Active, not recruiting
Florianopolis, SC, Brazil, 88034-000
Novartis Investigative Site Active, not recruiting
Campinas, SP, Brazil, 13083-970
Novartis Investigative Site Withdrawn
São Paulo, SP, Brazil, 01401-901
Novartis Investigative Site Completed
São Paulo, SP, Brazil, 04023-900
Bulgaria
Novartis Investigative Site Withdrawn
Plovdiv, Bulgaria, 4004
Novartis Investigative Site Withdrawn
Sofia, Bulgaria, 1784
Novartis Investigative Site Completed
Sofia, Bulgaria, 1784
Novartis Investigative Site Completed
Varna, Bulgaria, 9010
Canada, British Columbia
Novartis Investigative Site Withdrawn
Vancouver, British Columbia, Canada, V5Z 4E6
Novartis Investigative Site Completed
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Nova Scotia
Novartis Investigative Site Completed
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Novartis Investigative Site Completed
Hamilton, Ontario, Canada, L8V 5C2
Novartis Investigative Site Withdrawn
London, Ontario, Canada, N6A 4L6
Novartis Investigative Site Completed
Ottawa, Ontario, Canada, K1H 8L6
Novartis Investigative Site Completed
Toronto, Ontario, Canada, M5G1X5
Canada, Quebec
Novartis Investigative Site Withdrawn
Montreal, Quebec, Canada, H2L 4M1
Novartis Investigative Site Active, not recruiting
Montreal, Quebec, Canada, H1T 2M4
Novartis Investigative Site Active, not recruiting
Montreal, Quebec, Canada, H3A 1A1
Novartis Investigative Site Withdrawn
Sherbrooke, Quebec, Canada, J1H 5N4
Canada
Novartis Investigative Site Completed
Quebec, Canada, G1R 2J6
China, Beijing
Novartis Investigative Site Completed
Beijing, Beijing, China, 100730
China, Jiangsu
Novartis Investigative Site Active, not recruiting
Nanjing, Jiangsu, China, 210002
China
Novartis Investigative Site Active, not recruiting
Beijing, China, 100036
Novartis Investigative Site Active, not recruiting
Guangzhou, China, 510060
Novartis Investigative Site Active, not recruiting
Shanghai, China, 200433
Novartis Investigative Site Active, not recruiting
Shanghai, China, 200032
Colombia
Novartis Investigative Site Withdrawn
Bogotá, Cundinamarca, Colombia, 110111
Novartis Investigative Site Withdrawn
Bogotá, Colombia, 00000
Novartis Investigative Site Recruiting
Monteria, Colombia
Novartis Investigative Site Active, not recruiting
Pereira, Colombia
Czech Republic
Novartis Investigative Site Completed
Olomouc, Czech Republic, 775 20
Novartis Investigative Site Withdrawn
Praha 5, Czech Republic, 150 06
Denmark
Novartis Investigative Site Completed
Herlev, Denmark, DK-2730
Novartis Investigative Site Active, not recruiting
Århus C, Denmark, DK-8000
Egypt
Novartis Investigative Site Active, not recruiting
Alexandria, Egypt
Novartis Investigative Site Terminated
Cairo, Egypt
Novartis Investigative Site Active, not recruiting
Cairo, Egypt
Finland
Novartis Investigative Site Withdrawn
HUS, Finland, FIN-00029
France
Novartis Investigative Site Completed
Bordeaux, France, 33076
Novartis Investigative Site Terminated
Chambray-lès-Tours, France, 37170
Novartis Investigative Site Withdrawn
Lille Cedex, France, 59020
Novartis Investigative Site Completed
Lyon Cedex, France, 69373
Novartis Investigative Site Completed
Marseille Cedex 05, France, 13385
Novartis Investigative Site Completed
Paris Cedex 13, France, 75651
Novartis Investigative Site Completed
Saint-Herblain Cédex, France, 44805
Novartis Investigative Site Withdrawn
Toulouse Cedex 3, France, 31052
Novartis Investigative Site Completed
Toulouse Cedex 4, France, 31054
Novartis Investigative Site Completed
Vandoeuvre les Nancy, France, 54511
Novartis Investigative Site Completed
Villejuif Cedex, France, 94805
Germany
Novartis Investigative Site Active, not recruiting
Bad Saarow, Germany, 155226
Novartis Investigative Site Withdrawn
Berlin, Germany, 13125
Novartis Investigative Site Completed
Duesseldorf, Germany, 40479
Novartis Investigative Site Completed
Essen, Germany, 45122
Novartis Investigative Site Withdrawn
Frankfurt, Germany, 60488
Novartis Investigative Site Withdrawn
Freiburg, Germany, 79106
Novartis Investigative Site Active, not recruiting
Hannover, Germany, 30625
Novartis Investigative Site Terminated
Mannheim, Germany, 68167
Novartis Investigative Site Completed
Muenchen, Germany, 81377
Novartis Investigative Site Terminated
Weiden, Germany, 92637
Greece
Novartis Investigative Site Withdrawn
Athens, Greece, GR-106 76
Novartis Investigative Site Withdrawn
Athens, Greece, GR 12461
Novartis Investigative Site Withdrawn
Athens, Greece, GR-151 23
Novartis Investigative Site Withdrawn
Larissa, Greece, GR 41110
Novartis Investigative Site Withdrawn
Larissa, Greece, 412 21
Novartis Investigative Site Withdrawn
Patra - RIO, Greece, GR- 26504
Novartis Investigative Site Withdrawn
Thessaloniki, Greece, GR 540 07
Hong Kong
Novartis Investigative Site Active, not recruiting
Hong Kong SAR, Hong Kong
Hungary
Novartis Investigative Site Completed
Budapest, Hungary, 1062
Novartis Investigative Site Completed
Budapest, Hungary, 1097
Israel
Novartis Investigative Site Completed
Haifa, Israel, 31096
Novartis Investigative Site Withdrawn
Jerusalem, Israel, 91120
Novartis Investigative Site Withdrawn
Petach Tikva, Israel, 49100
Novartis Investigative Site Completed
Ramat Gan, Israel, 52621
Novartis Investigative Site Withdrawn
Tel-Aviv, Israel, 64239
Italy
Novartis Investigative Site Active, not recruiting
Bologna, BO, Italy, 40138
Novartis Investigative Site Active, not recruiting
San Giovanni Rotondo, FG, Italy, 71013
Novartis Investigative Site Completed
Firenze, FI, Italy, 50134
Novartis Investigative Site Completed
Genova, GE, Italy, 16132
Novartis Investigative Site Completed
Milano, MI, Italy, 20133
Novartis Investigative Site Active, not recruiting
Modena, MO, Italy, 41100
Novartis Investigative Site Terminated
Palermo, PA, Italy, 90127
Novartis Investigative Site Completed
Aviano, PN, Italy, 33081
Novartis Investigative Site Withdrawn
Roma, RM, Italy, 00168
Novartis Investigative Site Completed
Candiolo, TO, Italy, 10060
Novartis Investigative Site Completed
Torino, TO, Italy, 10153
Japan
Novartis Investigative Site Completed
Nagoya, Aichi, Japan, 464-8681
Novartis Investigative Site Withdrawn
Kamogawa, Chiba, Japan, 296-8602
Novartis Investigative Site Completed
Kashiwa, Chiba, Japan, 277-8577
Novartis Investigative Site Completed
Fukuoka-city, Fukuoka, Japan, 812-8582
Novartis Investigative Site Completed
Sapporo-city, Hokkaido, Japan, 060-8648
Novartis Investigative Site Completed
Yokohama, Kanagawa, Japan, 241-8515
Novartis Investigative Site Completed
Kumamoto City, Kumamoto, Japan, 860-8556
Novartis Investigative Site Completed
Sendai-city, Miyagi, Japan, 980-8574
Novartis Investigative Site Completed
Niigata-city, Niigata, Japan, 951-8520
Novartis Investigative Site Completed
Kurashiki, Okayama, Japan, 701-0192
Novartis Investigative Site Completed
Suita-city, Osaka, Japan, 565-0871
Novartis Investigative Site Completed
Sunto-gun, Shizuoka, Japan, 411-8777
Novartis Investigative Site Completed
Chuo-ku, Tokyo, Japan, 104-0045
Novartis Investigative Site Withdrawn
Koto, Tokyo, Japan, 135-8550
Novartis Investigative Site Withdrawn
Shinjuku-ku, Tokyo, Japan, 160-8582
Novartis Investigative Site Completed
Gifu, Japan, 501-1194
Novartis Investigative Site Completed
Osaka, Japan, 540-0006
Novartis Investigative Site Completed
Toyama, Japan, 930-0194
Korea, Republic of
Novartis Investigative Site Completed
Seoul, Korea, Korea, Republic of, 135-710
Novartis Investigative Site Completed
Seoul, Korea, Republic of, 738-736
Novartis Investigative Site Completed
Suwon, Korea, Republic of, 442-721
Mexico
Novartis Investigative Site Completed
México, Distrito Federal, Mexico, 14080
Novartis Investigative Site Withdrawn
México, Distrito Federal, Mexico, 06720
Novartis Investigative Site Completed
León, Guanajuato, Mexico, 37000
Novartis Investigative Site Withdrawn
Morelia, Michoacán, Mexico, 58270
Novartis Investigative Site Withdrawn
Monterrey, Nuevo León, Mexico, 64710
Novartis Investigative Site Withdrawn
Monterrey, Nuevo León, Mexico, 64460
Novartis Investigative Site Withdrawn
Chihuahua, Mexico, 31000
Netherlands
Novartis Investigative Site Withdrawn
Groningen, Netherlands, 9713 GZ
Novartis Investigative Site Completed
Leiden, Netherlands, 2300 RC
Norway
Novartis Investigative Site Withdrawn
Bergen, Norway, 5021
Novartis Investigative Site Completed
Oslo, Norway, NO-0310
Poland
Novartis Investigative Site Completed
Kraków, Poland, 31-501
Novartis Investigative Site Active, not recruiting
Warszawa, Poland, 02-781
Romania
Novartis Investigative Site Active, not recruiting
Craiova, Dolj, Romania, 200535
Novartis Investigative Site Active, not recruiting
Bucharest, Romania, 022328
Novartis Investigative Site Active, not recruiting
Cluj-Napoca, Romania, 3400
Novartis Investigative Site Active, not recruiting
Iasi, Romania, 700106
Russian Federation
Novartis Investigative Site Active, not recruiting
Kazan, Tatarstan Republic, Russian Federation, 420029
Novartis Investigative Site Active, not recruiting
Ekaterinburg, Russian Federation, 620036
Novartis Investigative Site Active, not recruiting
Moscow, Russian Federation, 115478
Novartis Investigative Site Active, not recruiting
St. Petersburg, Russian Federation, 198255
Singapore
Novartis Investigative Site Completed
Singapore, Singapore, 119228
Novartis Investigative Site Completed
Singapore, Singapore, 169610
Slovakia
Novartis Investigative Site Completed
Bratislava, Slovak Republic, Slovakia, 83310
South Africa
Novartis Investigative Site Completed
Cape Town, South Africa, 7500
Novartis Investigative Site Terminated
Johannesburg, South Africa, 2000
Novartis Investigative Site Terminated
Pretoria, South Africa, 0002
Novartis Investigative Site Active, not recruiting
Pretoria, South Africa, 0001
Novartis Investigative Site Terminated
Pretoria, South Africa, 0027
Spain
Novartis Investigative Site Withdrawn
Cordoba, Andalucia, Spain, 14004
Novartis Investigative Site Withdrawn
Granada, Andalucia, Spain, 18014
Novartis Investigative Site Withdrawn
Sevilla, Andalucia, Spain, 41009
Novartis Investigative Site Completed
Oviedo, Asturias, Spain, 33006
Novartis Investigative Site Terminated
Sabadell, Barcelona, Spain, 08208
Novartis Investigative Site Withdrawn
Barcelona, Cataluña, Spain, 08035
Novartis Investigative Site Completed
Barcelona, Spain, 08025
Novartis Investigative Site Withdrawn
Madrid, Spain, 28041
Novartis Investigative Site Completed
Madrid, Spain, 28046
Sweden
Novartis Investigative Site Completed
Goteborg, Sweden, SE-413 45
Novartis Investigative Site Completed
Linköping, Sweden, SE-581 85
Novartis Investigative Site Completed
Lund, Sweden, SE-221 85
Novartis Investigative Site Completed
Stockholm, Sweden, SE-171 76
Novartis Investigative Site Completed
Umeå, Sweden, SE-901 85
Novartis Investigative Site Completed
Uppsala, Sweden, SE-751 85
Taiwan
Novartis Investigative Site Terminated
Taipei, Taiwan, ROC, Taiwan, 112
Novartis Investigative Site Completed
Lin-Ko, Taiwan, 33305
Novartis Investigative Site Completed
Niaosong Township, Taiwan, 83301
Novartis Investigative Site Completed
Taipei, Taiwan, 10002
Thailand
Novartis Investigative Site Active, not recruiting
Bangkok, Thailand, 10700
Novartis Investigative Site Active, not recruiting
Bangkok, Thailand, 10330
Novartis Investigative Site Active, not recruiting
Khon Kaen, Thailand, 40002
Novartis Investigative Site Active, not recruiting
Songkla, Thailand, 90110
Turkey
Novartis Investigative Site Terminated
Adana, Turkey, 01330
Novartis Investigative Site Completed
Ankara, Turkey, 06500
Novartis Investigative Site Completed
Ankara, Turkey, 06100
Novartis Investigative Site Active, not recruiting
Ankara, Turkey, 06100
Novartis Investigative Site Completed
Izmir, Turkey, 35340
Novartis Investigative Site Terminated
Izmir, Turkey, 35040
Novartis Investigative Site Completed
Kartal, Turkey, 34890
United Kingdom
Novartis Investigative Site Withdrawn
Birmingham, United Kingdom, B9 5SS
Novartis Investigative Site Completed
Cambridge, United Kingdom, CB2 2QQ
Novartis Investigative Site Withdrawn
Derby, United Kingdom, DE1 2QY
Novartis Investigative Site Active, not recruiting
Glasgow, United Kingdom, G12 0YN
Novartis Investigative Site Active, not recruiting
London, United Kingdom, SW3 6JJ
Novartis Investigative Site Active, not recruiting
London, United Kingdom, NW1 2BU
Novartis Investigative Site Active, not recruiting
Manchester, United Kingdom, M20 4BX
Novartis Investigative Site Active, not recruiting
Newcastle-upon-Tyne, United Kingdom, NE7 7DN
Venezuela
Novartis Investigative Site Completed
Caracas, Distrito Capital, Venezuela, 1010
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00785785     History of Changes
Other Study ID Numbers: CAMN107G2301, 2008-004758-34
Study First Received: November 4, 2008
Last Updated: March 13, 2014
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Austria: Federal Office for Safety in Health Care
Brazil: National Health Surveillance Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Canada: Health Canada
China: Food and Drug Administration
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Romania: State Institute for Drug Control
Denmark: Danish Medicines Agency
Egypt: Ministry of Health and Population
Finland: Finnish Medicines Agency
Germany: Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)
Greece: National Organization of Medicines
Hong Kong: Department of Health
Hungary: National Institute of Pharmacy
Israel: Ministry of Health
Italy: National Institute of Health
Japan: Pharmaceuticals and Medical Devices Agency
Korea: Food and Drug Administration
Mexico: Federal Commission for Protection Against Health Risks
Netherlands: Ministry of Health, Welfare and Sport
Norway: Norwegian Medicines Agency
Poland: Ministry of Health
Russia: Ministry of Health of the Russian Federation
Singapore: Health Sciences Authority
Slovakia: State Institute for Drug Control
South Africa: Department of Health
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
Taiwan: Department of Health
Thailand: local IRB
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Venezuela:Instituto Nacional de Higiene "Rafael Rangel"

Keywords provided by Novartis:
Unresectable GIST
metastatic GIST
nilotinib
AMN107
imatinib
STI571

Additional relevant MeSH terms:
Gastrointestinal Stromal Tumors
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Imatinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 18, 2014