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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00785785
First received: November 4, 2008
Last updated: August 20, 2014
Last verified: August 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 ]

Enrollment: 644
Study Start Date: March 2009
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (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

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Locations
United States, Alabama
Birmingham Hematology and Oncology Associates
Birmingham, Alabama, United States, 35205
United States, Arizona
Northern Arizona Hematology/Oncology Associates, P.C. Dept. of No. AZ Hem-Onc
Flagstaff, Arizona, United States, 86001
United States, California
City of Hope National Medical Center Dept.ofCityofHopeMedicalCtr(4)
Duarte, California, United States, 91010-3000
City of Hope National Medical Center Regulatory Document
Duarte, California, United States, 91010-3000
University of California San Diego Dept of Moores Cancer Ctr (2)
La Jolla, California, United States, 92093-0658
University of California at Los Angeles GI Oncology Program
Los Angeles, California, United States, 90095
Stanford University Medical Center Stanford Cancer Center
Stanford, California, United States, 94304
United States, Colorado
University of Colorado Dept. of Univ. of Colorado
Aurora, Colorado, United States, 80045
Rocky Mountain Cancer Centers Dept. of Rocky Mountain Cancer
Greenwood Village, Colorado, United States
United States, District of Columbia
Washington Hospital Center Wash Hospital
Washington, District of Columbia, United States, 20010
United States, Florida
Ocala Oncology Center Dept. of Ocala Oncology Center
Ocala, Florida, United States, 34474
United States, Idaho
Kootenai Medical Center Dept.ofKootenai Med.Ctr.
Coeur d'Alene, Idaho, United States, 83814
United States, Illinois
Northwestern University Clinical Research Office (2)
Chicago, Illinois, United States, 60611
United States, Massachusetts
Dana Farber Cancer Institute Centerfor Sarcoma&BoneOncology
Boston, Massachusetts, United States, 02115
United States, Michigan
University of Michigan Comprehensive Cancer Center DeptofMichiganCancerCenter(6)
Ann Arbor, Michigan, United States, 48109-0944
United States, Minnesota
Minnesota Oncology Hematology, P.A. SC
Minneapolis, Minnesota, United States, 55404
Mayo Clinic - Rochester Division of Hematology
Rochester, Minnesota, United States, 55905
United States, New York
New York Oncology Hematology, P.C. NYOH Amsterdam
Troy, New York, United States, 12180
New York Oncology Hematology, P.C. NYOH@AlbanyMedicalCenter(2)
Troy, New York, United States, 12180
United States, Pennsylvania
University of Pennsylvania Medical Center CAMN107G2301
Philadelphia, Pennsylvania, United States, 19104-4283
United States, Tennessee
Vanderbilt Univeristy Ingram Cancer Ctr.
Nashville, Tennessee, United States, 37232
United States, Texas
Texas Oncology, P.A. Tex Onc (2)
Bedford, Texas, United States, 76022
Texas Oncology, P.A. Wichita Falls
Dallas, Texas, United States, 75246
University of Texas Southwestern Medical Center DeptofSimmons Cancer Center(3)
Dallas, Texas, United States, 75390-8527
University of Texas/MD Anderson Cancer Center Dept. of MD Anderson (13)
Houston, Texas, United States, 77030-4009
Cancer Care Centers of South Texas / HOAST CCC of So. TX- San Antonio(2)
San Antonio, Texas, United States, 78229
Tyler Cancer Center Dept.ofTylerCancerCtr. (2)
Tyler, Texas, United States, 75702
United States, Utah
University of Utah / Huntsman Cancer Institute Dept.ofHuntsmanCancerInst.(3)
Salt Lake City, Utah, United States, 84112
Argentina
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Caba, Buenos Aires, Argentina, C1426ANZ
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Rosario, Santa Fe, Argentina, S2000PBH
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Buenos Aires, Argentina, C1264AAA
Austria
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Graz, Austria, 8036
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Innsbruck, Austria, 6020
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Leoben, Austria, A-8700
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Wels, Austria, 4600
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Wien, Austria, A-1090
Brazil
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Uberlândia, MG, Brazil, 38408-150
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Florianopolis, SC, Brazil, 88034-000
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Campinas, SP, Brazil, 13083-970
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São Paulo, SP, Brazil, 04023-900
Bulgaria
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Sofia, Bulgaria, 1784
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Varna, Bulgaria, 9010
Canada, British Columbia
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Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
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Hamilton, Ontario, Canada, L8V 5C2
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Ottawa, Ontario, Canada, K1H 8L6
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Toronto, Ontario, Canada, M5G1X5
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Montreal, Quebec, Canada, H1T 2M4
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Montreal, Quebec, Canada, H3A 1A1
Canada
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Quebec, Canada, G1R 2J6
China, Beijing
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Beijing, Beijing, China, 100730
China, Jiangsu
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Nanjing, Jiangsu, China, 210002
China
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Beijing, China, 100036
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Guangzhou, China, 510060
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Shanghai, China, 200433
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Shanghai, China, 200032
Colombia
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Monteria, Colombia
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Pereira, Colombia
Czech Republic
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Olomouc, Czech Republic, 775 20
Denmark
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Herlev, Denmark, DK-2730
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Århus C, Denmark, DK-8000
Egypt
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Alexandria, Egypt
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Cairo, Egypt
France
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Bordeaux, France, 33076
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Chambray-lès-Tours, France, 37170
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Lyon Cedex, France, 69373
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Marseille Cedex 05, France, 13385
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Paris Cedex 13, France, 75651
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Saint-Herblain Cédex, France, 44805
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Toulouse Cedex 4, France, 31054
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Vandoeuvre les Nancy, France, 54511
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Villejuif Cedex, France, 94805
Germany
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Bad Saarow, Germany, 155226
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Duesseldorf, Germany, 40479
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Essen, Germany, 45122
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Hannover, Germany, 30625
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Mannheim, Germany, 68167
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Muenchen, Germany, 81377
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Weiden, Germany, 92637
Hong Kong
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Hong Kong SAR, Hong Kong
Hungary
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Budapest, Hungary, 1062
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Budapest, Hungary, 1097
Israel
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Haifa, Israel, 31096
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Ramat Gan, Israel, 52621
Italy
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Bologna, BO, Italy, 40138
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San Giovanni Rotondo, FG, Italy, 71013
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Firenze, FI, Italy, 50134
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Genova, GE, Italy, 16132
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Milano, MI, Italy, 20133
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Modena, MO, Italy, 41100
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Palermo, PA, Italy, 90127
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Aviano, PN, Italy, 33081
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Candiolo, TO, Italy, 10060
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Torino, TO, Italy, 10153
Japan
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Nagoya, Aichi, Japan, 464-8681
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Kashiwa, Chiba, Japan, 277-8577
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Fukuoka-city, Fukuoka, Japan, 812-8582
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Sapporo-city, Hokkaido, Japan, 060-8648
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Yokohama, Kanagawa, Japan, 241-8515
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Kumamoto City, Kumamoto, Japan, 860-8556
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Sendai-city, Miyagi, Japan, 980-8574
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Niigata-city, Niigata, Japan, 951-8520
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Kurashiki, Okayama, Japan, 701-0192
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Suita-city, Osaka, Japan, 565-0871
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Sunto-gun, Shizuoka, Japan, 411-8777
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Chuo-ku, Tokyo, Japan, 104-0045
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Gifu, Japan, 501-1194
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Osaka, Japan, 540-0006
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Toyama, Japan, 930-0194
Korea, Republic of
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Seoul, Korea, Korea, Republic of, 135-710
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Seoul, Korea, Republic of, 738-736
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Suwon, Korea, Republic of, 442-721
Mexico
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México, Distrito Federal, Mexico, 14080
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León, Guanajuato, Mexico, 37000
Netherlands
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Leiden, Netherlands, 2300 RC
Norway
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Oslo, Norway, NO-0310
Poland
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Kraków, Poland, 31-501
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Warszawa, Poland, 02-781
Romania
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Craiova, Dolj, Romania, 200535
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Bucharest, Romania, 022328
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Cluj-Napoca, Romania, 3400
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Iasi, Romania, 700106
Russian Federation
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Kazan, Tatarstan Republic, Russian Federation, 420029
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Ekaterinburg, Russian Federation, 620036
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Moscow, Russian Federation, 115478
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St. Petersburg, Russian Federation, 198255
Singapore
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Singapore, Singapore, 119228
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Singapore, Singapore, 169610
Slovakia
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Bratislava, Slovak Republic, Slovakia, 83310
South Africa
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Cape Town, South Africa, 7500
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Johannesburg, South Africa, 2000
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Pretoria, South Africa, 0001
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Pretoria, South Africa, 0027
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Pretoria, South Africa, 0002
Spain
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Oviedo, Asturias, Spain, 33006
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Sabadell, Barcelona, Spain, 08208
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Barcelona, Spain, 08025
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Madrid, Spain, 28046
Sweden
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Goteborg, Sweden, SE-413 45
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Linköping, Sweden, SE-581 85
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Lund, Sweden, SE-221 85
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Stockholm, Sweden, SE-171 76
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Umeå, Sweden, SE-901 85
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Uppsala, Sweden, SE-751 85
Taiwan
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Taipei, Taiwan, ROC, Taiwan, 112
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Lin-Ko, Taiwan, 33305
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Niaosong Township, Taiwan, 83301
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Taipei, Taiwan, 10002
Thailand
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Bangkok, Thailand, 10700
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Bangkok, Thailand, 10330
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Khon Kaen, Thailand, 40002
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Songkla, Thailand, 90110
Turkey
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Adana, Turkey, 01330
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Ankara, Turkey, 06500
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Ankara, Turkey, 06100
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Izmir, Turkey, 35340
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Izmir, Turkey, 35040
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Kartal, Turkey, 34890
United Kingdom
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Cambridge, United Kingdom, CB2 2QQ
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Glasgow, United Kingdom, G12 0YN
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London, United Kingdom, SW3 6JJ
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London, United Kingdom, NW1 2BU
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Manchester, United Kingdom, M20 4BX
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Newcastle-upon-Tyne, United Kingdom, NE7 7DN
Venezuela
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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: August 20, 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
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Imatinib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014