Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
644 participants
INTERVENTIONAL
2009-03-31
2014-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Nilotinib
nilotinib 400 mg twice a day
Nilotinib (AMN107)
Imatinib
imatinib 400 mg once daily
imatinib (STI571)
Interventions
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Nilotinib (AMN107)
imatinib (STI571)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
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
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Birmingham Hematology and Oncology Associates
Birmingham, Alabama, United States
Northern Arizona Hematology/Oncology Associates, P.C. Dept. of No. AZ Hem-Onc
Flagstaff, Arizona, United States
City of Hope National Medical Center Dept.ofCityofHopeMedicalCtr(4)
Duarte, California, United States
City of Hope National Medical Center Regulatory Document
Duarte, California, United States
University of California San Diego - Moores Cancer Center Dept of Moores Cancer Ctr (2)
La Jolla, California, United States
University of California at Los Angeles GI Oncology Program
Los Angeles, California, United States
Stanford University Medical Center Stanford Cancer Center
Stanford, California, United States
University of Colorado Dept. of Univ. of Colorado
Aurora, Colorado, United States
Rocky Mountain Cancer Centers Dept. of Rocky Mountain Cancer
Greenwood Village, Colorado, United States
Washington Hospital Center Wash Hospital
Washington D.C., District of Columbia, United States
Ocala Oncology Center Dept. of Ocala Oncology Center
Ocala, Florida, United States
Kootenai Medical Center Dept.ofKootenai Med.Ctr.
Coeur d'Alene, Idaho, United States
Northwestern University Clinical Research Office (2)
Chicago, Illinois, United States
Dana Farber Cancer Institute Centerfor Sarcoma&BoneOncology
Boston, Massachusetts, United States
University of Michigan Comprehensive Cancer Center DeptofMichiganCancerCenter(6)
Ann Arbor, Michigan, United States
Minnesota Oncology Hematology, P.A. SC
Minneapolis, Minnesota, United States
Mayo Clinic - Rochester Division of Hematology
Rochester, Minnesota, United States
New York Oncology Hematology, P.C. NYOH Amsterdam
Troy, New York, United States
New York Oncology Hematology, P.C. NYOH@AlbanyMedicalCenter(2)
Troy, New York, United States
University of Pennsylvania Medical Center CAMN107G2301
Philadelphia, Pennsylvania, United States
Vanderbilt Univeristy Ingram Cancer Ctr.
Nashville, Tennessee, United States
Texas Oncology, P.A. Tex Onc (2)
Bedford, Texas, United States
Texas Oncology Wichita Falls
Dallas, Texas, United States
University of Texas Southwestern Medical Center DeptofSimmons Cancer Center(3)
Dallas, Texas, United States
University of Texas/MD Anderson Cancer Center Dept. of MD Anderson (13)
Houston, Texas, United States
Cancer Care Centers of South Texas / HOAST CCC of So. TX- San Antonio(2)
San Antonio, Texas, United States
Tyler Cancer Center Dept.ofTylerCancerCtr. (2)
Tyler, Texas, United States
University of Utah / Huntsman Cancer Institute Dept.ofHuntsmanCancerInst.(3)
Salt Lake City, Utah, United States
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Haifa, , Israel
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Bologna, BO, Italy
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Aviano, PN, Italy
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Torino, TO, Italy
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Nagoya, Aichi-ken, Japan
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Kashiwa, Chiba, Japan
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Fukuoka, Fukuoka, Japan
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Kazan', Tatarstan Republic, Russia
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Taipei, Taiwan, ROC, Taiwan
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Adana, Turkey, Turkey (Türkiye)
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Balcova / Izmir, , Turkey (Türkiye)
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Kartal, , Turkey (Türkiye)
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Newcastle upon Tyne, Newcastle-upon-Tyne, United Kingdom
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London, , United Kingdom
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Manchester, , United Kingdom
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Caracas, Distrito Federal, Venezuela
Countries
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References
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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.
Related Links
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Visit NovartisClinicalTrials.com: Pre-qualify for a trial, and view a list of trials and participating study centers.
Other Identifiers
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2008-004758-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CAMN107G2301
Identifier Type: -
Identifier Source: org_study_id
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