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

Primary Purpose

Gastrointestinal Stromal Tumor (GIST)

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Nilotinib (AMN107)
imatinib (STI571)
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastrointestinal Stromal Tumor (GIST) focused on measuring Unresectable GIST, metastatic GIST, nilotinib, AMN107, imatinib, STI571

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Birmingham Hematology and Oncology Associates
  • Northern Arizona Hematology/Oncology Associates, P.C. Dept. of No. AZ Hem-Onc
  • City of Hope National Medical Center Dept.ofCityofHopeMedicalCtr(4)
  • City of Hope National Medical Center Regulatory Document
  • University of California San Diego - Moores Cancer Center Dept of Moores Cancer Ctr (2)
  • University of California at Los Angeles GI Oncology Program
  • Stanford University Medical Center Stanford Cancer Center
  • University of Colorado Dept. of Univ. of Colorado
  • Rocky Mountain Cancer Centers Dept. of Rocky Mountain Cancer
  • Washington Hospital Center Wash Hospital
  • Ocala Oncology Center Dept. of Ocala Oncology Center
  • Kootenai Medical Center Dept.ofKootenai Med.Ctr.
  • Northwestern University Clinical Research Office (2)
  • Dana Farber Cancer Institute Centerfor Sarcoma&BoneOncology
  • University of Michigan Comprehensive Cancer Center DeptofMichiganCancerCenter(6)
  • Minnesota Oncology Hematology, P.A. SC
  • Mayo Clinic - Rochester Division of Hematology
  • New York Oncology Hematology, P.C. NYOH Amsterdam
  • New York Oncology Hematology, P.C. NYOH@AlbanyMedicalCenter(2)
  • University of Pennsylvania Medical Center CAMN107G2301
  • Vanderbilt Univeristy Ingram Cancer Ctr.
  • Texas Oncology, P.A. Tex Onc (2)
  • Texas Oncology Wichita Falls
  • University of Texas Southwestern Medical Center DeptofSimmons Cancer Center(3)
  • University of Texas/MD Anderson Cancer Center Dept. of MD Anderson (13)
  • Cancer Care Centers of South Texas / HOAST CCC of So. TX- San Antonio(2)
  • Tyler Cancer Center Dept.ofTylerCancerCtr. (2)
  • University of Utah / Huntsman Cancer Institute Dept.ofHuntsmanCancerInst.(3)
  • Novartis Investigative Site
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Nilotinib

Imatinib

Arm Description

nilotinib 400 mg twice a day

imatinib 400 mg once daily

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 4, 2008
Last Updated
May 10, 2016
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00785785
Brief Title
A Study of Nilotinib Versus Imatinib in GIST Patients
Acronym
ENESTg1
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 Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Stromal Tumor (GIST)
Keywords
Unresectable GIST, metastatic GIST, nilotinib, AMN107, imatinib, STI571

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
644 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nilotinib
Arm Type
Experimental
Arm Description
nilotinib 400 mg twice a day
Arm Title
Imatinib
Arm Type
Active Comparator
Arm Description
imatinib 400 mg once daily
Intervention Type
Drug
Intervention Name(s)
Nilotinib (AMN107)
Intervention Type
Drug
Intervention Name(s)
imatinib (STI571)
Other Intervention Name(s)
Glivec/Gleevec
Primary Outcome Measure Information:
Title
Time to Progression Free Survival (PFS)
Description
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
Time Frame
up to month 37

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 Other protocol-defined inclusion/exclusion criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Birmingham Hematology and Oncology Associates
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Northern Arizona Hematology/Oncology Associates, P.C. Dept. of No. AZ Hem-Onc
City
Flagstaff
State/Province
Arizona
ZIP/Postal Code
86001
Country
United States
Facility Name
City of Hope National Medical Center Dept.ofCityofHopeMedicalCtr(4)
City
Duarte
State/Province
California
ZIP/Postal Code
91010-3000
Country
United States
Facility Name
City of Hope National Medical Center Regulatory Document
City
Duarte
State/Province
California
ZIP/Postal Code
91010-3000
Country
United States
Facility Name
University of California San Diego - Moores Cancer Center Dept of Moores Cancer Ctr (2)
City
La Jolla
State/Province
California
ZIP/Postal Code
92093-0658
Country
United States
Facility Name
University of California at Los Angeles GI Oncology Program
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Stanford University Medical Center Stanford Cancer Center
City
Stanford
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
University of Colorado Dept. of Univ. of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Rocky Mountain Cancer Centers Dept. of Rocky Mountain Cancer
City
Greenwood Village
State/Province
Colorado
Country
United States
Facility Name
Washington Hospital Center Wash Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Ocala Oncology Center Dept. of Ocala Oncology Center
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
Facility Name
Kootenai Medical Center Dept.ofKootenai Med.Ctr.
City
Coeur d'Alene
State/Province
Idaho
ZIP/Postal Code
83814
Country
United States
Facility Name
Northwestern University Clinical Research Office (2)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Dana Farber Cancer Institute Centerfor Sarcoma&BoneOncology
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University of Michigan Comprehensive Cancer Center DeptofMichiganCancerCenter(6)
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0944
Country
United States
Facility Name
Minnesota Oncology Hematology, P.A. SC
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
Mayo Clinic - Rochester Division of Hematology
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
New York Oncology Hematology, P.C. NYOH Amsterdam
City
Troy
State/Province
New York
ZIP/Postal Code
12180
Country
United States
Facility Name
New York Oncology Hematology, P.C. NYOH@AlbanyMedicalCenter(2)
City
Troy
State/Province
New York
ZIP/Postal Code
12180
Country
United States
Facility Name
University of Pennsylvania Medical Center CAMN107G2301
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-4283
Country
United States
Facility Name
Vanderbilt Univeristy Ingram Cancer Ctr.
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Texas Oncology, P.A. Tex Onc (2)
City
Bedford
State/Province
Texas
ZIP/Postal Code
76022
Country
United States
Facility Name
Texas Oncology Wichita Falls
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
University of Texas Southwestern Medical Center DeptofSimmons Cancer Center(3)
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-8527
Country
United States
Facility Name
University of Texas/MD Anderson Cancer Center Dept. of MD Anderson (13)
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
Cancer Care Centers of South Texas / HOAST CCC of So. TX- San Antonio(2)
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Tyler Cancer Center Dept.ofTylerCancerCtr. (2)
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Facility Name
University of Utah / Huntsman Cancer Institute Dept.ofHuntsmanCancerInst.(3)
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Novartis Investigative Site
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1426ANZ
Country
Argentina
Facility Name
Novartis Investigative Site
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000PBH
Country
Argentina
Facility Name
Novartis Investigative Site
City
Buenos Aires
ZIP/Postal Code
C1264AAA
Country
Argentina
Facility Name
Novartis Investigative Site
City
Innsbruck
State/Province
Tyrol
ZIP/Postal Code
6020
Country
Austria
Facility Name
Novartis Investigative Site
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Novartis Investigative Site
City
Leoben
ZIP/Postal Code
A-8700
Country
Austria
Facility Name
Novartis Investigative Site
City
Wels
ZIP/Postal Code
4600
Country
Austria
Facility Name
Novartis Investigative Site
City
Wien
ZIP/Postal Code
A-1090
Country
Austria
Facility Name
Novartis Investigative Site
City
Uberlândia
State/Province
MG
ZIP/Postal Code
38408-150
Country
Brazil
Facility Name
Novartis Investigative Site
City
Florianopolis
State/Province
SC
ZIP/Postal Code
88034-000
Country
Brazil
Facility Name
Novartis Investigative Site
City
Campinas
State/Province
SP
ZIP/Postal Code
13083-970
Country
Brazil
Facility Name
Novartis Investigative Site
City
São Paulo
State/Province
SP
ZIP/Postal Code
04023-900
Country
Brazil
Facility Name
Novartis Investigative Site
City
Sofia
ZIP/Postal Code
1784
Country
Bulgaria
Facility Name
Novartis Investigative Site
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
Facility Name
Novartis Investigative Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
Novartis Investigative Site
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Facility Name
Novartis Investigative Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
Novartis Investigative Site
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Novartis Investigative Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G1X5
Country
Canada
Facility Name
Novartis Investigative Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Novartis Investigative Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 1A1
Country
Canada
Facility Name
Novartis Investigative Site
City
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
Facility Name
Novartis Investigative Site
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Novartis Investigative Site
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China
Facility Name
Novartis Investigative Site
City
Beijing
ZIP/Postal Code
100036
Country
China
Facility Name
Novartis Investigative Site
City
Guangzhou
ZIP/Postal Code
510060
Country
China
Facility Name
Novartis Investigative Site
City
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Novartis Investigative Site
City
Shanghai
ZIP/Postal Code
200433
Country
China
Facility Name
Novartis Investigative Site
City
Pereira
Country
Colombia
Facility Name
Novartis Investigative Site
City
Olomouc
ZIP/Postal Code
775 20
Country
Czech Republic
Facility Name
Novartis Investigative Site
City
Herlev
ZIP/Postal Code
DK-2730
Country
Denmark
Facility Name
Novartis Investigative Site
City
Århus C
ZIP/Postal Code
DK-8000
Country
Denmark
Facility Name
Novartis Investigative Site
City
Alexandria
Country
Egypt
Facility Name
Novartis Investigative Site
City
Cairo
Country
Egypt
Facility Name
Novartis Investigative Site
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Novartis Investigative Site
City
Chambray-lès-Tours
ZIP/Postal Code
37170
Country
France
Facility Name
Novartis Investigative Site
City
Lyon Cedex
ZIP/Postal Code
69373
Country
France
Facility Name
Novartis Investigative Site
City
Marseille Cedex 05
ZIP/Postal Code
13385
Country
France
Facility Name
Novartis Investigative Site
City
Paris Cedex 13
ZIP/Postal Code
75651
Country
France
Facility Name
Novartis Investigative Site
City
Saint-Herblain Cédex
ZIP/Postal Code
44805
Country
France
Facility Name
Novartis Investigative Site
City
Toulouse Cedex 4
ZIP/Postal Code
31054
Country
France
Facility Name
Novartis Investigative Site
City
Vandoeuvre les Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Novartis Investigative Site
City
Villejuif Cedex
ZIP/Postal Code
94805
Country
France
Facility Name
Novartis Investigative Site
City
Bad Saarow
ZIP/Postal Code
15526
Country
Germany
Facility Name
Novartis Investigative Site
City
Duesseldorf
ZIP/Postal Code
40479
Country
Germany
Facility Name
Novartis Investigative Site
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Novartis Investigative Site
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Novartis Investigative Site
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
Novartis Investigative Site
City
Muenchen
ZIP/Postal Code
81377
Country
Germany
Facility Name
Novartis Investigative Site
City
Weiden
ZIP/Postal Code
92637
Country
Germany
Facility Name
Novartis Investigative Site
City
Hong Kong SAR
Country
Hong Kong
Facility Name
Novartis Investigative Site
City
Budapest
ZIP/Postal Code
1062
Country
Hungary
Facility Name
Novartis Investigative Site
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
Facility Name
Novartis Investigative Site
City
Haifa
ZIP/Postal Code
3525408
Country
Israel
Facility Name
Novartis Investigative Site
City
Ramat Gan
ZIP/Postal Code
5266202
Country
Israel
Facility Name
Novartis Investigative Site
City
Bologna
State/Province
BO
ZIP/Postal Code
40138
Country
Italy
Facility Name
Novartis Investigative Site
City
San Giovanni Rotondo
State/Province
FG
ZIP/Postal Code
71013
Country
Italy
Facility Name
Novartis Investigative Site
City
Firenze
State/Province
FI
ZIP/Postal Code
50134
Country
Italy
Facility Name
Novartis Investigative Site
City
Genova
State/Province
GE
ZIP/Postal Code
16132
Country
Italy
Facility Name
Novartis Investigative Site
City
Milano
State/Province
MI
ZIP/Postal Code
20133
Country
Italy
Facility Name
Novartis Investigative Site
City
Modena
State/Province
MO
ZIP/Postal Code
41100
Country
Italy
Facility Name
Novartis Investigative Site
City
Palermo
State/Province
PA
ZIP/Postal Code
90127
Country
Italy
Facility Name
Novartis Investigative Site
City
Aviano
State/Province
PN
ZIP/Postal Code
33081
Country
Italy
Facility Name
Novartis Investigative Site
City
Candiolo
State/Province
TO
ZIP/Postal Code
10060
Country
Italy
Facility Name
Novartis Investigative Site
City
Torino
State/Province
TO
ZIP/Postal Code
10153
Country
Italy
Facility Name
Novartis Investigative Site
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
Novartis Investigative Site
City
Kashiwa
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
Novartis Investigative Site
City
Fukuoka-city
State/Province
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Novartis Investigative Site
City
Sapporo-city
State/Province
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Facility Name
Novartis Investigative Site
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
241-8515
Country
Japan
Facility Name
Novartis Investigative Site
City
Kumamoto City
State/Province
Kumamoto
ZIP/Postal Code
860-8556
Country
Japan
Facility Name
Novartis Investigative Site
City
Sendai-city
State/Province
Miyagi
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
Novartis Investigative Site
City
Niigata-city
State/Province
Niigata
ZIP/Postal Code
951-8520
Country
Japan
Facility Name
Novartis Investigative Site
City
Kurashiki
State/Province
Okayama
ZIP/Postal Code
701-0192
Country
Japan
Facility Name
Novartis Investigative Site
City
Suita-city
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
Novartis Investigative Site
City
Sunto-gun
State/Province
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
Facility Name
Novartis Investigative Site
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
Novartis Investigative Site
City
Gifu
ZIP/Postal Code
501-1194
Country
Japan
Facility Name
Novartis Investigative Site
City
Osaka
ZIP/Postal Code
540-0006
Country
Japan
Facility Name
Novartis Investigative Site
City
Toyama
ZIP/Postal Code
930-0194
Country
Japan
Facility Name
Novartis Investigative Site
City
Suwon
State/Province
Gyeonggi-do
ZIP/Postal Code
443-380
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
State/Province
Korea
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
State/Province
Korea
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
México
State/Province
Distrito Federal
ZIP/Postal Code
14080
Country
Mexico
Facility Name
Novartis Investigative Site
City
León
State/Province
Guanajuato
ZIP/Postal Code
37000
Country
Mexico
Facility Name
Novartis Investigative Site
City
Chihuahua
ZIP/Postal Code
31000
Country
Mexico
Facility Name
Novartis Investigative Site
City
Leiden
ZIP/Postal Code
2300 RC
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Oslo
ZIP/Postal Code
NO-0310
Country
Norway
Facility Name
Novartis Investigative Site
City
Kraków
ZIP/Postal Code
31-501
Country
Poland
Facility Name
Novartis Investigative Site
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Novartis Investigative Site
City
Craiova
State/Province
Dolj
ZIP/Postal Code
200535
Country
Romania
Facility Name
Novartis Investigative Site
City
Bucharest
ZIP/Postal Code
022328
Country
Romania
Facility Name
Novartis Investigative Site
City
Cluj-Napoca
ZIP/Postal Code
3400
Country
Romania
Facility Name
Novartis Investigative Site
City
Iasi
ZIP/Postal Code
700106
Country
Romania
Facility Name
Novartis Investigative Site
City
Kazan
State/Province
Tatarstan Republic
ZIP/Postal Code
420029
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Ekaterinburg
ZIP/Postal Code
620036
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
St. Petersburg
ZIP/Postal Code
198255
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Singapore
ZIP/Postal Code
119228
Country
Singapore
Facility Name
Novartis Investigative Site
City
Singapore
ZIP/Postal Code
169610
Country
Singapore
Facility Name
Novartis Investigative Site
City
Bratislava
State/Province
Slovak Republic
ZIP/Postal Code
83310
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Cape Town
ZIP/Postal Code
7500
Country
South Africa
Facility Name
Novartis Investigative Site
City
Johannesburg
ZIP/Postal Code
2199
Country
South Africa
Facility Name
Novartis Investigative Site
City
Pretoria
ZIP/Postal Code
0001
Country
South Africa
Facility Name
Novartis Investigative Site
City
Pretoria
ZIP/Postal Code
0002
Country
South Africa
Facility Name
Novartis Investigative Site
City
Pretoria
ZIP/Postal Code
0027
Country
South Africa
Facility Name
Novartis Investigative Site
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33006
Country
Spain
Facility Name
Novartis Investigative Site
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
Facility Name
Novartis Investigative Site
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Novartis Investigative Site
City
Goteborg
ZIP/Postal Code
SE-413 45
Country
Sweden
Facility Name
Novartis Investigative Site
City
Linköping
ZIP/Postal Code
SE-581 85
Country
Sweden
Facility Name
Novartis Investigative Site
City
Lund
ZIP/Postal Code
SE-221 85
Country
Sweden
Facility Name
Novartis Investigative Site
City
Stockholm
ZIP/Postal Code
SE-171 76
Country
Sweden
Facility Name
Novartis Investigative Site
City
Umeå
ZIP/Postal Code
SE-901 85
Country
Sweden
Facility Name
Novartis Investigative Site
City
Uppsala
ZIP/Postal Code
SE-751 85
Country
Sweden
Facility Name
Novartis Investigative Site
City
Taipei
State/Province
Taiwan, ROC
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Lin-Kou
ZIP/Postal Code
33305
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Niaosong Township
ZIP/Postal Code
83301
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
Novartis Investigative Site
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Novartis Investigative Site
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Facility Name
Novartis Investigative Site
City
Songkla
ZIP/Postal Code
90110
Country
Thailand
Facility Name
Novartis Investigative Site
City
Adana
ZIP/Postal Code
01330
Country
Turkey
Facility Name
Novartis Investigative Site
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Novartis Investigative Site
City
Ankara
ZIP/Postal Code
06500
Country
Turkey
Facility Name
Novartis Investigative Site
City
Balcova / Izmir
ZIP/Postal Code
35340
Country
Turkey
Facility Name
Novartis Investigative Site
City
Izmir
ZIP/Postal Code
35040
Country
Turkey
Facility Name
Novartis Investigative Site
City
Kartal
ZIP/Postal Code
34890
Country
Turkey
Facility Name
Novartis Investigative Site
City
Cambridge
ZIP/Postal Code
CB2 2QQ
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Glasgow
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
London
ZIP/Postal Code
NW1 2BU
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Newcastle-upon-Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Caracas
State/Province
Distrito Capital
ZIP/Postal Code
1010
Country
Venezuela

12. IPD Sharing Statement

Citations:
PubMed Identifier
25882987
Citation
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.
Results Reference
derived
Links:
URL
http://www.novartisclinicaltrials.com/etrials/searchTrial.do?trialID=717
Description
Visit NovartisClinicalTrials.com: Pre-qualify for a trial, and view a list of trials and participating study centers.

Learn more about this trial

A Study of Nilotinib Versus Imatinib in GIST Patients

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