A Study of Nilotinib Versus Imatinib in GIST Patients

NCT00785785 | Completed Phase 3 Results

• 2 other identifiers: CAMN107G23012008-004758-34
• Study Type: interventional
• Target: 644
• Locations: 35 countries
• Sites: 165

Brief Summary

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

Conditions

Gastrointestinal Stromal Tumor (GIST)

Keywords

Unresectable GIST; metastatic GIST; nilotinib; AMN107; imatinib; STI571

Outcome Measures

Primary Outcomes (1)

• Time to Progression Free Survival (PFS)

  PFS was defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause. Progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

  up to month 37

Study Arms (2)

Nilotinib

EXPERIMENTAL

nilotinib 400 mg twice a day

Drug: Nilotinib (AMN107)

Imatinib

ACTIVE COMPARATOR

imatinib 400 mg once daily

Drug: imatinib (STI571)

Interventions

Nilotinib (AMN107) DRUG

Nilotinib

imatinib (STI571) DRUG

Also known as: Glivec/Gleevec

Imatinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• At least one measurable site of disease on CT/MRI scan
• Performance status ≤ 2 (capable of self-care but unable to carry out any work)
• Normal organ, electrolyte and marrow function

You may not qualify if:

• 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.
• Disease progression during adjuvant therapy with imatinib
• 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.
• Impaired cardiac function

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (165)

Birmingham Hematology and Oncology Associates

Birmingham, Alabama, 35205, United States

Location

Northern Arizona Hematology/Oncology Associates, P.C. Dept. of No. AZ Hem-Onc

Flagstaff, Arizona, 86001, United States

Location

City of Hope National Medical Center Dept.ofCityofHopeMedicalCtr(4)

Duarte, California, 91010-3000, United States

Location

City of Hope National Medical Center Regulatory Document

Duarte, California, 91010-3000, United States

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University of California San Diego - Moores Cancer Center Dept of Moores Cancer Ctr (2)

La Jolla, California, 92093-0658, United States

Location

University of California at Los Angeles GI Oncology Program

Los Angeles, California, 90095, United States

Location

Stanford University Medical Center Stanford Cancer Center

Stanford, California, 94304, United States

Location

University of Colorado Dept. of Univ. of Colorado

Aurora, Colorado, 80045, United States

Location

Rocky Mountain Cancer Centers Dept. of Rocky Mountain Cancer

Greenwood Village, Colorado, United States

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Washington Hospital Center Wash Hospital

Washington D.C., District of Columbia, 20010, United States

Location

Ocala Oncology Center Dept. of Ocala Oncology Center

Ocala, Florida, 34474, United States

Location

Kootenai Medical Center Dept.ofKootenai Med.Ctr.

Coeur d'Alene, Idaho, 83814, United States

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Northwestern University Clinical Research Office (2)

Chicago, Illinois, 60611, United States

Location

Dana Farber Cancer Institute Centerfor Sarcoma&BoneOncology

Boston, Massachusetts, 02215, United States

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University of Michigan Comprehensive Cancer Center DeptofMichiganCancerCenter(6)

Ann Arbor, Michigan, 48109-0944, United States

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Minnesota Oncology Hematology, P.A. SC

Minneapolis, Minnesota, 55404, United States

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Mayo Clinic - Rochester Division of Hematology

Rochester, Minnesota, 55905, United States

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New York Oncology Hematology, P.C. NYOH Amsterdam

Troy, New York, 12180, United States

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New York Oncology Hematology, P.C. NYOH@AlbanyMedicalCenter(2)

Troy, New York, 12180, United States

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University of Pennsylvania Medical Center CAMN107G2301

Philadelphia, Pennsylvania, 19104-4283, United States

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Vanderbilt Univeristy Ingram Cancer Ctr.

Nashville, Tennessee, 37232, United States

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Texas Oncology, P.A. Tex Onc (2)

Bedford, Texas, 76022, United States

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Texas Oncology Wichita Falls

Dallas, Texas, 75246, United States

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University of Texas Southwestern Medical Center DeptofSimmons Cancer Center(3)

Dallas, Texas, 75390-8527, United States

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University of Texas/MD Anderson Cancer Center Dept. of MD Anderson (13)

Houston, Texas, 77030-4009, United States

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Cancer Care Centers of South Texas / HOAST CCC of So. TX- San Antonio(2)

San Antonio, Texas, 78229, United States

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Tyler Cancer Center Dept.ofTylerCancerCtr. (2)

Tyler, Texas, 75702, United States

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University of Utah / Huntsman Cancer Institute Dept.ofHuntsmanCancerInst.(3)

Salt Lake City, Utah, 84112, United States

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Novartis Investigative Site

Buenos Aires, Buenos Aires, C1264AAA, Argentina

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Caba, Buenos Aires, C1426ANZ, Argentina

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Rosario, Santa Fe Province, S2000PBH, Argentina

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Innsbruck, Tyrol, 6020, Austria

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Graz, 8036, Austria

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Leoben, A-8700, Austria

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Vienna, A-1090, Austria

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Wels, 4600, Austria

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Uberlândia, Minas Gerais, 38408-150, Brazil

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Florianópolis, Santa Catarina, 88034-000, Brazil

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Campinas, São Paulo, 13083-970, Brazil

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São Paulo, São Paulo, 04023-900, Brazil

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Sofia, 1784, Bulgaria

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Varna, 9010, Bulgaria

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Vancouver, British Columbia, V5Z 4E6, Canada

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Halifax, Nova Scotia, B3H 1V7, Canada

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Hamilton, Ontario, L8V 5C2, Canada

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Ottawa, Ontario, K1H 8L6, Canada

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Toronto, Ontario, M5G1X5, Canada

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Montreal, Quebec, H1T 2M4, Canada

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Montreal, Quebec, H3A 1A1, Canada

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Québec, Quebec, G1R 2J6, Canada

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Beijing, Beijing Municipality, 100730, China

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Nanjing, Jiangsu, 210002, China

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Beijing, 100036, China

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Guangzhou, 510060, China

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Shanghai, 200032, China

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Shanghai, 200433, China

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Pereira, Colombia

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Olomouc, 775 20, Czechia

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Århus C, DK-8000, Denmark

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Herlev, DK-2730, Denmark

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Alexandria, Egypt

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Cairo, Egypt

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Bordeaux, 33076, France

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Chambray-lès-Tours, 37170, France

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Lyon, 69373, France

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Marseille, 13385, France

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Paris, 75651, France

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Saint-Herblain Cédex, 44805, France

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Toulouse, 31054, France

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Vandœuvre-lès-Nancy, 54511, France

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Villejuif, 94805, France

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Bad Saarow, 15526, Germany

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Düsseldorf, 40479, Germany

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Essen, 45122, Germany

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Hanover, 30625, Germany

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Mannheim, 68167, Germany

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München, 81377, Germany

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Weiden, 92637, Germany

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Hong Kong SAR, Hong Kong

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Budapest, 1062, Hungary

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Budapest, 1097, Hungary

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Haifa, 3525408, Israel

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Ramat Gan, 5266202, Israel

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Bologna, BO, 40138, Italy

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San Giovanni Rotondo, FG, 71013, Italy

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Florence, FI, 50134, Italy

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Genova, GE, 16132, Italy

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Milan, MI, 20133, Italy

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Modena, MO, 41100, Italy

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Palermo, PA, 90127, Italy

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Aviano, PN, 33081, Italy

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Candiolo, TO, 10060, Italy

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Torino, TO, 10153, Italy

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Nagoya, Aichi-ken, 464-8681, Japan

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Kashiwa, Chiba, 277-8577, Japan

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Fukuoka, Fukuoka, 812-8582, Japan

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Gifu, Gifu, 501-1194, Japan

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Sapporo, Hokkaido, 060-8648, Japan

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Yokohama, Kanagawa, 241-8515, Japan

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Kumamoto, Kumamoto, 860-8556, Japan

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Sendai, Miyagi, 980-8574, Japan

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Niigata, Niigata, 951-8520, Japan

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Kurashiki, Okayama-ken, 701-0192, Japan

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Osaka, Osaka, 540-0006, Japan

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Suita, Osaka, 565-0871, Japan

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Sunto-gun, Shizuoka, 411-8777, Japan

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Chuo-ku, Tokyo, 104-0045, Japan

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Toyama, Toyama, 930-0194, Japan

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Chihuahua City, Chihuahua, 31000, Mexico

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León, Guanajuato, 37000, Mexico

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Mexico City, Mexico City, 14080, Mexico

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Leiden, 2300 RC, Netherlands

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Oslo, NO-0310, Norway

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Krakow, 31-501, Poland

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Warsaw, 02-781, Poland

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Craiova, Dolj, 200535, Romania

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Bucharest, 022328, Romania

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Cluj-Napoca, 3400, Romania

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Iași, 700106, Romania

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Kazan', Tatarstan Republic, 420029, Russia

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Moscow, 115478, Russia

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Saint Petersburg, 198255, Russia

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Yekaterinburg, 620036, Russia

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Singapore, Singapore, 119228, Singapore

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Singapore, Singapore, 169610, Singapore

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Bratislava, Slovak Republic, 83310, Slovakia

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Cape Town, 7500, South Africa

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Johannesburg, 2199, South Africa

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Pretoria, 0001, South Africa

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Pretoria, 0002, South Africa

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Pretoria, 0027, South Africa

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Suwon, Gyeonggi-do, 443-380, South Korea

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Seoul, Korea, 05505, South Korea

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Seoul, Korea, 06351, South Korea

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Barcelona, Barcelona, 08041, Spain

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Sabadell, Barcelona, 08208, Spain

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Madrid, Madrid, 28046, Spain

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Oviedo, Principality of Asturias, 33006, Spain

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Gothenburg, SE-413 45, Sweden

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Linköping, SE-581 85, Sweden

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Lund, SE-221 85, Sweden

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Stockholm, SE-171 76, Sweden

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Umeå, SE-901 85, Sweden

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Uppsala, SE-751 85, Sweden

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Niaosong Township, Taiwan, 83301, Taiwan

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Taipei, Taiwan, 10002, Taiwan

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Taipei, Taiwan, ROC, 112, Taiwan

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Linkou District, 33305, Taiwan

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Bangkok, 10330, Thailand

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Bangkok, 10700, Thailand

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Khon Kaen, 40002, Thailand

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Songkhla, 90110, Thailand

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Adana, Turkey, 01330, Turkey (Türkiye)

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Ankara, Turkey, 06100, Turkey (Türkiye)

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Ankara, Turkey, 06500, Turkey (Türkiye)

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Izmir, Turkey, 35040, Turkey (Türkiye)

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Balcova / Izmir, 35340, Turkey (Türkiye)

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Kartal, 34890, Turkey (Türkiye)

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Newcastle upon Tyne, Newcastle-upon-Tyne, NE7 7DN, United Kingdom

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Cambridge, CB2 2QQ, United Kingdom

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Glasgow, G12 0YN, United Kingdom

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London, NW1 2BU, United Kingdom

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London, SW3 6JJ, United Kingdom

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Manchester, M20 4BX, United Kingdom

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Caracas, Distrito Federal, 1010, Venezuela

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Related Publications (1)

• Blay JY, Shen L, Kang YK, Rutkowski P, Qin S, Nosov D, Wan D, Trent J, Srimuninnimit V, Papai Z, Le Cesne A, Novick S, Taningco L, Mo S, Green S, Reichardt P, Demetri GD. Nilotinib versus imatinib as first-line therapy for patients with unresectable or metastatic gastrointestinal stromal tumours (ENESTg1): a randomised phase 3 trial. Lancet Oncol. 2015 May;16(5):550-60. doi: 10.1016/S1470-2045(15)70105-1. Epub 2015 Apr 14.

  PMID: 25882987 DERIVED

Related Links

• Visit NovartisClinicalTrials.com: Pre-qualify for a trial, and view a list of trials and participating study centers.

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors

Interventions

nilotinib; Imatinib Mesylate

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2008
• First Posted: November 5, 2008
• Study Start: March 1, 2009
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: June 16, 2016
• Results First Posted: April 7, 2016

Record last verified: 2016-05

Locations

AU (5); PL (2); GB (6); CN (6); ME (3); AR (3); ZA (5); ES (4); CZ (1); RU (4); IL (2); JP (15); EG (2); SG (2); DK (2); TH (4); KR (3); FR (9); SL (1); CO (1); BR (4); HK (1); DE (7); US (28); NL (1); TU (6); IT (10); SE (6); TW (4); BU (2); CA (8); NO (1); RO (4); HU (2); VE (1)