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A Study of Nilotinib Versus Imatinib in GIST Patients

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Gastrointestinal Stromal Tumor (GIST)

Intervention: Nilotinib (AMN107) (Drug); imatinib (STI571) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis Pharmaceuticals

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals

Summary

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

Clinical Details

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)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: To compare Progression Free Survival (PFS) of nilotinib and imatinib when used as initial therapy in patents with unresectable and/ or metastatic GIST.

Secondary outcome:

To compare disease control rate (DCR) of nilotinib and imatinib

To compare time to treatment failure (TTF) of nilotinib and imatinib

To compare overall survival (OS) of nilotinib and imatinib

To compare time to progression (TTP), response rate (RR), time to tumor response and assess duration of response of nilotinib and imatinib

To compare safety and tolerability of nilotinib and imatinib

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Novartis Investigative Site, Buenos Aires C1264AAA, Argentina

Novartis Investigative Site, Graz 8036, Austria

Novartis Investigative Site, Innsbruck 6020, Austria

Novartis Investigative Site, Leoben A-8700, Austria

Novartis Investigative Site, Wels 4600, Austria

Novartis Investigative Site, Wien A-1090, Austria

Novartis Investigative Site, Sofia 1784, Bulgaria

Novartis Investigative Site, Varna 9010, Bulgaria

Novartis Investigative Site, Quebec G1R 2J6, Canada

Novartis Investigative Site, Beijing 100036, China

Novartis Investigative Site, Guangzhou 510060, China

Novartis Investigative Site, Shanghai 200433, China

Novartis Investigative Site, Shanghai 200032, China

Novartis Investigative Site, Pereira, Colombia

Novartis Investigative Site, Olomouc 775 20, Czech Republic

Novartis Investigative Site, Herlev DK-2730, Denmark

Novartis Investigative Site, Århus C DK-8000, Denmark

Novartis Investigative Site, Alexandria, Egypt

Novartis Investigative Site, Cairo, Egypt

Novartis Investigative Site, Bordeaux 33076, France

Novartis Investigative Site, Chambray-lès-Tours 37170, France

Novartis Investigative Site, Lyon Cedex 69373, France

Novartis Investigative Site, Marseille Cedex 05 13385, France

Novartis Investigative Site, Paris Cedex 13 75651, France

Novartis Investigative Site, Saint-Herblain Cédex 44805, France

Novartis Investigative Site, Toulouse Cedex 4 31054, France

Novartis Investigative Site, Vandoeuvre les Nancy 54511, France

Novartis Investigative Site, Villejuif Cedex 94805, France

Novartis Investigative Site, Bad Saarow 155226, Germany

Novartis Investigative Site, Duesseldorf 40479, Germany

Novartis Investigative Site, Essen 45122, Germany

Novartis Investigative Site, Hannover 30625, Germany

Novartis Investigative Site, Mannheim 68167, Germany

Novartis Investigative Site, Muenchen 81377, Germany

Novartis Investigative Site, Weiden 92637, Germany

Novartis Investigative Site, Hong Kong SAR, Hong Kong

Novartis Investigative Site, Budapest 1062, Hungary

Novartis Investigative Site, Budapest 1097, Hungary

Novartis Investigative Site, Haifa 31096, Israel

Novartis Investigative Site, Ramat Gan 5266202, Israel

Novartis Investigative Site, Gifu 501-1194, Japan

Novartis Investigative Site, Osaka 540-0006, Japan

Novartis Investigative Site, Toyama 930-0194, Japan

Novartis Investigative Site, Leiden 2300 RC, Netherlands

Novartis Investigative Site, Oslo NO-0310, Norway

Novartis Investigative Site, Kraków 31-501, Poland

Novartis Investigative Site, Warszawa 02-781, Poland

Novartis Investigative Site, Bucharest 022328, Romania

Novartis Investigative Site, Cluj-Napoca 3400, Romania

Novartis Investigative Site, Iasi 700106, Romania

Novartis Investigative Site, Ekaterinburg 620036, Russian Federation

Novartis Investigative Site, Moscow 115478, Russian Federation

Novartis Investigative Site, St. Petersburg 198255, Russian Federation

Novartis Investigative Site, Singapore 119228, Singapore

Novartis Investigative Site, Singapore 169610, Singapore

Novartis Investigative Site, Cape Town 7500, South Africa

Novartis Investigative Site, Johannesburg 2199, South Africa

Novartis Investigative Site, Pretoria 0001, South Africa

Novartis Investigative Site, Pretoria 0002, South Africa

Novartis Investigative Site, Pretoria 0027, South Africa

Novartis Investigative Site, Barcelona 08025, Spain

Novartis Investigative Site, Madrid 28046, Spain

Novartis Investigative Site, Goteborg SE-413 45, Sweden

Novartis Investigative Site, Linköping SE-581 85, Sweden

Novartis Investigative Site, Lund SE-221 85, Sweden

Novartis Investigative Site, Stockholm SE-171 76, Sweden

Novartis Investigative Site, Umeå SE-901 85, Sweden

Novartis Investigative Site, Uppsala SE-751 85, Sweden

Novartis Investigative Site, Lin-Kou 33305, Taiwan

Novartis Investigative Site, Niaosong Township 83301, Taiwan

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Novartis Investigative Site, Bangkok 10330, Thailand

Novartis Investigative Site, Bangkok 10700, Thailand

Novartis Investigative Site, Khon Kaen 40002, Thailand

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Novartis Investigative Site, Ankara 06100, Turkey

Novartis Investigative Site, Ankara 06500, Turkey

Novartis Investigative Site, Balcova / Izmir 35340, Turkey

Novartis Investigative Site, Izmir 35040, Turkey

Novartis Investigative Site, Kartal 34890, Turkey

Novartis Investigative Site, Cambridge CB2 2QQ, United Kingdom

Novartis Investigative Site, Glasgow G12 0YN, United Kingdom

Novartis Investigative Site, London SW3 6JJ, United Kingdom

Novartis Investigative Site, London NW1 2BU, United Kingdom

Novartis Investigative Site, Manchester M20 4BX, United Kingdom

Novartis Investigative Site, Newcastle-upon-Tyne NE7 7DN, United Kingdom

Novartis Investigative Site, Nagoya, Aichi 464-8681, Japan

Birmingham Hematology and Oncology Associates, Birmingham, Alabama 35205, United States

Northern Arizona Hematology/Oncology Associates, P.C. Dept. of No. AZ Hem-Onc, Flagstaff, Arizona 86001, United States

Novartis Investigative Site, Oviedo, Asturias 33006, Spain

Novartis Investigative Site, Bologna, BO 40138, Italy

Novartis Investigative Site, Sabadell, Barcelona 08208, Spain

Novartis Investigative Site, Beijing, Beijing 100730, China

Novartis Investigative Site, Vancouver, British Columbia V5Z 4E6, Canada

Novartis Investigative Site, Caba, Buenos Aires C1426ANZ, Argentina

City of Hope National Medical Center Dept.ofCityofHopeMedicalCtr(4), Duarte, California 91010-3000, United States

City of Hope National Medical Center Regulatory Document, Duarte, California 91010-3000, United States

University of California San Diego - Moores Cancer Center Dept of Moores Cancer Ctr (2), La Jolla, California 92093-0658, United States

University of California at Los Angeles GI Oncology Program, Los Angeles, California 90095, United States

Stanford University Medical Center Stanford Cancer Center, Stanford, California 94304, United States

Novartis Investigative Site, Kashiwa, Chiba 277-8577, Japan

University of Colorado Dept. of Univ. of Colorado, Aurora, Colorado 80045, United States

Rocky Mountain Cancer Centers Dept. of Rocky Mountain Cancer, Greenwood Village, Colorado, United States

Washington Hospital Center Wash Hospital, Washington, District of Columbia 20010, United States

Novartis Investigative Site, Caracas, Distrito Capital 1010, Venezuela

Novartis Investigative Site, México, Distrito Federal 14080, Mexico

Novartis Investigative Site, Craiova, Dolj 200535, Romania

Novartis Investigative Site, San Giovanni Rotondo, FG 71013, Italy

Novartis Investigative Site, Firenze, FI 50134, Italy

Ocala Oncology Center Dept. of Ocala Oncology Center, Ocala, Florida 34474, United States

Novartis Investigative Site, Fukuoka-city, Fukuoka 812-8582, Japan

Novartis Investigative Site, Genova, GE 16132, Italy

Novartis Investigative Site, León, Guanajuato 37000, Mexico

Novartis Investigative Site, Suwon, Gyeonggi-do 443-380, Korea, Republic of

Novartis Investigative Site, Sapporo-city, Hokkaido 060-8648, Japan

Kootenai Medical Center Dept.ofKootenai Med.Ctr., Coeur d'Alene, Idaho 83814, United States

Northwestern University Clinical Research Office (2), Chicago, Illinois 60611, United States

Novartis Investigative Site, Nanjing, Jiangsu 210002, China

Novartis Investigative Site, Yokohama, Kanagawa 241-8515, Japan

Novartis Investigative Site, Seoul, Korea 135-710, Korea, Republic of

Novartis Investigative Site, Seoul, Korea 138-736, Korea, Republic of

Novartis Investigative Site, Kumamoto City, Kumamoto 860-8556, Japan

Novartis Investigative Site, Uberlândia, MG 38408-150, Brazil

Novartis Investigative Site, Milano, MI 20133, Italy

Novartis Investigative Site, Modena, MO 41100, Italy

Dana Farber Cancer Institute Centerfor Sarcoma&BoneOncology, Boston, Massachusetts 02215, United States

University of Michigan Comprehensive Cancer Center DeptofMichiganCancerCenter(6), Ann Arbor, Michigan 48109-0944, United States

Minnesota Oncology Hematology, P.A. SC, Minneapolis, Minnesota 55404, United States

Mayo Clinic - Rochester Division of Hematology, Rochester, Minnesota 55905, United States

Novartis Investigative Site, Sendai-city, Miyagi 980-8574, Japan

New York Oncology Hematology, P.C. NYOH Amsterdam, Troy, New York 12180, United States

New York Oncology Hematology, P.C. NYOH@AlbanyMedicalCenter(2), Troy, New York 12180, United States

Novartis Investigative Site, Niigata-city, Niigata 951-8520, Japan

Novartis Investigative Site, Halifax, Nova Scotia B3H 1V7, Canada

Novartis Investigative Site, Kurashiki, Okayama 701-0192, Japan

Novartis Investigative Site, Hamilton, Ontario L8V 5C2, Canada

Novartis Investigative Site, Ottawa, Ontario K1H 8L6, Canada

Novartis Investigative Site, Toronto, Ontario M5G1X5, Canada

Novartis Investigative Site, Suita-city, Osaka 565-0871, Japan

Novartis Investigative Site, Palermo, PA 90127, Italy

Novartis Investigative Site, Aviano, PN 33081, Italy

University of Pennsylvania Medical Center CAMN107G2301, Philadelphia, Pennsylvania 19104-4283, United States

Novartis Investigative Site, Montreal, Quebec H3A 1A1, Canada

Novartis Investigative Site, Montreal, Quebec H1T 2M4, Canada

Novartis Investigative Site, Florianopolis, SC 88034-000, Brazil

Novartis Investigative Site, Campinas, SP 13083-970, Brazil

Novartis Investigative Site, São Paulo, SP 04023-900, Brazil

Novartis Investigative Site, Rosario, Santa Fe S2000PBH, Argentina

Novartis Investigative Site, Sunto-gun, Shizuoka 411-8777, Japan

Novartis Investigative Site, Bratislava, Slovak Republic 83310, Slovakia

Novartis Investigative Site, Candiolo, TO 10060, Italy

Novartis Investigative Site, Torino, TO 10153, Italy

Novartis Investigative Site, Taipei, Taiwan, ROC 112, Taiwan

Novartis Investigative Site, Kazan, Tatarstan Republic 420029, Russian Federation

Vanderbilt Univeristy Ingram Cancer Ctr., Nashville, Tennessee 37232, United States

Texas Oncology, P.A. Tex Onc (2), Bedford, Texas 76022, United States

Texas Oncology Wichita Falls, Dallas, Texas 75246, United States

University of Texas Southwestern Medical Center DeptofSimmons Cancer Center(3), Dallas, Texas 75390-8527, United States

University of Texas/MD Anderson Cancer Center Dept. of MD Anderson (13), Houston, Texas 77030-4009, United States

Cancer Care Centers of South Texas / HOAST CCC of So. TX- San Antonio(2), San Antonio, Texas 78229, United States

Tyler Cancer Center Dept.ofTylerCancerCtr. (2), Tyler, Texas 75702, United States

Novartis Investigative Site, Chuo-ku, Tokyo 104-0045, Japan

University of Utah / Huntsman Cancer Institute Dept.ofHuntsmanCancerInst.(3), Salt Lake City, Utah 84112, United States

Additional Information

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

Starting date: March 2009
Last updated: July 9, 2015

Page last updated: August 23, 2015

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