A Study of Nilotinib Versus Imatinib in GIST Patients

Gastrointestinal Stromal Tumor (GIST) Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00785785
• Other study ID #: CAMN107G2301
• Secondary ID: 2008-004758-34
• Status: Completed
• Phase: Phase 3
• First received: November 4, 2008
• Last updated: July 9, 2015
• Start date: March 2009
• Est. completion date: October 2014

Study information

• Verified date: July 2015
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaAustria: Federal Office for Safety in Health CareBrazil: National Health Surveillance AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Canada: Health CanadaChina: Food and Drug AdministrationColombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y AlimentosRomania: State Institute for Drug ControlDenmark: Danish Medicines AgencyEgypt: Ministry of Health and PopulationFinland: Finnish Medicines AgencyGermany: Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)Greece: National Organization of MedicinesHong Kong: Department of HealthHungary: National Institute of PharmacyIsrael: Ministry of HealthItaly: National Institute of HealthJapan: Pharmaceuticals and Medical Devices AgencyKorea: Food and Drug AdministrationMexico: Federal Commission for Protection Against Health RisksNetherlands: Ministry of Health, Welfare and SportNorway: Norwegian Medicines AgencyPoland: Ministry of HealthRussia: Ministry of Health of the Russian FederationSingapore: Health Sciences AuthoritySlovakia: State Institute for Drug ControlSouth Africa: Department of HealthSpain: Spanish Agency of MedicinesSweden: Medical Products AgencyTaiwan: Department of HealthThailand: local IRBTurkey: Ministry of HealthUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyVenezuela:Instituto Nacional de Higiene "Rafael Rangel"
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 644
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Gastrointestinal Stromal Tumor (GIST)
• Gastrointestinal Stromal Tumors

Intervention

Drug:
• Nilotinib (AMN107)

• imatinib (STI571)

Locations

Country	Name	City	State
Argentina	Novartis Investigative Site	Buenos Aires
Argentina	Novartis Investigative Site	Caba	Buenos Aires
Argentina	Novartis Investigative Site	Rosario	Santa Fe
Austria	Novartis Investigative Site	Graz
Austria	Novartis Investigative Site	Innsbruck
Austria	Novartis Investigative Site	Leoben
Austria	Novartis Investigative Site	Wels
Austria	Novartis Investigative Site	Wien
Brazil	Novartis Investigative Site	Campinas	SP
Brazil	Novartis Investigative Site	Florianopolis	SC
Brazil	Novartis Investigative Site	São Paulo	SP
Brazil	Novartis Investigative Site	Uberlândia	MG
Bulgaria	Novartis Investigative Site	Sofia
Bulgaria	Novartis Investigative Site	Varna
Canada	Novartis Investigative Site	Halifax	Nova Scotia
Canada	Novartis Investigative Site	Hamilton	Ontario
Canada	Novartis Investigative Site	Montreal	Quebec
Canada	Novartis Investigative Site	Montreal	Quebec
Canada	Novartis Investigative Site	Ottawa	Ontario
Canada	Novartis Investigative Site	Quebec
Canada	Novartis Investigative Site	Toronto	Ontario
Canada	Novartis Investigative Site	Vancouver	British Columbia
China	Novartis Investigative Site	Beijing	Beijing
China	Novartis Investigative Site	Beijing
China	Novartis Investigative Site	Guangzhou
China	Novartis Investigative Site	Nanjing	Jiangsu
China	Novartis Investigative Site	Shanghai
China	Novartis Investigative Site	Shanghai
Colombia	Novartis Investigative Site	Pereira
Czech Republic	Novartis Investigative Site	Olomouc
Denmark	Novartis Investigative Site	Århus C
Denmark	Novartis Investigative Site	Herlev
Egypt	Novartis Investigative Site	Alexandria
Egypt	Novartis Investigative Site	Cairo
France	Novartis Investigative Site	Bordeaux
France	Novartis Investigative Site	Chambray-lès-Tours
France	Novartis Investigative Site	Lyon Cedex
France	Novartis Investigative Site	Marseille Cedex 05
France	Novartis Investigative Site	Paris Cedex 13
France	Novartis Investigative Site	Saint-Herblain Cédex
France	Novartis Investigative Site	Toulouse Cedex 4
France	Novartis Investigative Site	Vandoeuvre les Nancy
France	Novartis Investigative Site	Villejuif Cedex
Germany	Novartis Investigative Site	Bad Saarow
Germany	Novartis Investigative Site	Duesseldorf
Germany	Novartis Investigative Site	Essen
Germany	Novartis Investigative Site	Hannover
Germany	Novartis Investigative Site	Mannheim
Germany	Novartis Investigative Site	Muenchen
Germany	Novartis Investigative Site	Weiden
Hong Kong	Novartis Investigative Site	Hong Kong SAR
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Budapest
Israel	Novartis Investigative Site	Haifa
Israel	Novartis Investigative Site	Ramat Gan
Italy	Novartis Investigative Site	Aviano	PN
Italy	Novartis Investigative Site	Bologna	BO
Italy	Novartis Investigative Site	Candiolo	TO
Italy	Novartis Investigative Site	Firenze	FI
Italy	Novartis Investigative Site	Genova	GE
Italy	Novartis Investigative Site	Milano	MI
Italy	Novartis Investigative Site	Modena	MO
Italy	Novartis Investigative Site	Palermo	PA
Italy	Novartis Investigative Site	San Giovanni Rotondo	FG
Italy	Novartis Investigative Site	Torino	TO
Japan	Novartis Investigative Site	Chuo-ku	Tokyo
Japan	Novartis Investigative Site	Fukuoka-city	Fukuoka
Japan	Novartis Investigative Site	Gifu
Japan	Novartis Investigative Site	Kashiwa	Chiba
Japan	Novartis Investigative Site	Kumamoto City	Kumamoto
Japan	Novartis Investigative Site	Kurashiki	Okayama
Japan	Novartis Investigative Site	Nagoya	Aichi
Japan	Novartis Investigative Site	Niigata-city	Niigata
Japan	Novartis Investigative Site	Osaka
Japan	Novartis Investigative Site	Sapporo-city	Hokkaido
Japan	Novartis Investigative Site	Sendai-city	Miyagi
Japan	Novartis Investigative Site	Suita-city	Osaka
Japan	Novartis Investigative Site	Sunto-gun	Shizuoka
Japan	Novartis Investigative Site	Toyama
Japan	Novartis Investigative Site	Yokohama	Kanagawa
Korea, Republic of	Novartis Investigative Site	Seoul	Korea
Korea, Republic of	Novartis Investigative Site	Seoul	Korea
Korea, Republic of	Novartis Investigative Site	Suwon	Gyeonggi-do
Mexico	Novartis Investigative Site	León	Guanajuato
Mexico	Novartis Investigative Site	México	Distrito Federal
Netherlands	Novartis Investigative Site	Leiden
Norway	Novartis Investigative Site	Oslo
Poland	Novartis Investigative Site	Kraków
Poland	Novartis Investigative Site	Warszawa
Romania	Novartis Investigative Site	Bucharest
Romania	Novartis Investigative Site	Cluj-Napoca
Romania	Novartis Investigative Site	Craiova	Dolj
Romania	Novartis Investigative Site	Iasi
Russian Federation	Novartis Investigative Site	Ekaterinburg
Russian Federation	Novartis Investigative Site	Kazan	Tatarstan Republic
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	St. Petersburg
Singapore	Novartis Investigative Site	Singapore
Singapore	Novartis Investigative Site	Singapore
Slovakia	Novartis Investigative Site	Bratislava	Slovak Republic
South Africa	Novartis Investigative Site	Cape Town
South Africa	Novartis Investigative Site	Johannesburg
South Africa	Novartis Investigative Site	Pretoria
South Africa	Novartis Investigative Site	Pretoria
South Africa	Novartis Investigative Site	Pretoria
Spain	Novartis Investigative Site	Barcelona
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Oviedo	Asturias
Spain	Novartis Investigative Site	Sabadell	Barcelona
Sweden	Novartis Investigative Site	Goteborg
Sweden	Novartis Investigative Site	Linköping
Sweden	Novartis Investigative Site	Lund
Sweden	Novartis Investigative Site	Stockholm
Sweden	Novartis Investigative Site	Umeå
Sweden	Novartis Investigative Site	Uppsala
Taiwan	Novartis Investigative Site	Lin-Kou
Taiwan	Novartis Investigative Site	Niaosong Township
Taiwan	Novartis Investigative Site	Taipei
Taiwan	Novartis Investigative Site	Taipei	Taiwan, ROC
Thailand	Novartis Investigative Site	Bangkok
Thailand	Novartis Investigative Site	Bangkok
Thailand	Novartis Investigative Site	Khon Kaen
Thailand	Novartis Investigative Site	Songkla
Turkey	Novartis Investigative Site	Adana
Turkey	Novartis Investigative Site	Ankara
Turkey	Novartis Investigative Site	Ankara
Turkey	Novartis Investigative Site	Balcova / Izmir
Turkey	Novartis Investigative Site	Izmir
Turkey	Novartis Investigative Site	Kartal
United Kingdom	Novartis Investigative Site	Cambridge
United Kingdom	Novartis Investigative Site	Glasgow
United Kingdom	Novartis Investigative Site	London
United Kingdom	Novartis Investigative Site	London
United Kingdom	Novartis Investigative Site	Manchester
United Kingdom	Novartis Investigative Site	Newcastle-upon-Tyne
United States	University of Michigan Comprehensive Cancer Center DeptofMichiganCancerCenter(6)	Ann Arbor	Michigan
United States	University of Colorado Dept. of Univ. of Colorado	Aurora	Colorado
United States	Texas Oncology, P.A. Tex Onc (2)	Bedford	Texas
United States	Birmingham Hematology and Oncology Associates	Birmingham	Alabama
United States	Dana Farber Cancer Institute Centerfor Sarcoma&BoneOncology	Boston	Massachusetts
United States	Northwestern University Clinical Research Office (2)	Chicago	Illinois
United States	Kootenai Medical Center Dept.ofKootenai Med.Ctr.	Coeur d'Alene	Idaho
United States	Texas Oncology Wichita Falls	Dallas	Texas
United States	University of Texas Southwestern Medical Center DeptofSimmons Cancer Center(3)	Dallas	Texas
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	Northern Arizona Hematology/Oncology Associates, P.C. Dept. of No. AZ Hem-Onc	Flagstaff	Arizona
United States	Rocky Mountain Cancer Centers Dept. of Rocky Mountain Cancer	Greenwood Village	Colorado
United States	University of Texas/MD Anderson Cancer Center Dept. of MD Anderson (13)	Houston	Texas
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	Minnesota Oncology Hematology, P.A. SC	Minneapolis	Minnesota
United States	Vanderbilt Univeristy Ingram Cancer Ctr.	Nashville	Tennessee
United States	Ocala Oncology Center Dept. of Ocala Oncology Center	Ocala	Florida
United States	University of Pennsylvania Medical Center CAMN107G2301	Philadelphia	Pennsylvania
United States	Mayo Clinic - Rochester Division of Hematology	Rochester	Minnesota
United States	University of Utah / Huntsman Cancer Institute Dept.ofHuntsmanCancerInst.(3)	Salt Lake City	Utah
United States	Cancer Care Centers of South Texas / HOAST CCC of So. TX- San Antonio(2)	San Antonio	Texas
United States	Stanford University Medical Center Stanford Cancer Center	Stanford	California
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	Tyler Cancer Center Dept.ofTylerCancerCtr. (2)	Tyler	Texas
United States	Washington Hospital Center Wash Hospital	Washington	District of Columbia
Venezuela	Novartis Investigative Site	Caracas	Distrito Capital

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Venezuela,  Argentina,  Austria,  Brazil,  Bulgaria,  Canada,  China,  Colombia,  Czech Republic,  Denmark,  Egypt,  France,  Germany,  Hong Kong,  Hungary,  Israel,  Italy,  Japan,  Korea, Republic of,  Mexico,  Netherlands,  Norway,  Poland,  Romania,  Russian Federation,  Singapore,  Slovakia,  South Africa,  Spain,  Sweden,  Taiwan,  Thailand,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare Progression Free Survival (PFS) of nilotinib and imatinib when used as initial therapy in patents with unresectable and/ or metastatic GIST.		throughout the study	No
Secondary	To compare disease control rate (DCR) of nilotinib and imatinib		throughout the study	No
Secondary	To compare time to treatment failure (TTF) of nilotinib and imatinib		throughout the study	No
Secondary	To compare overall survival (OS) of nilotinib and imatinib		throughout the study	No
Secondary	To compare time to progression (TTP), response rate (RR), time to tumor response and assess duration of response of nilotinib and imatinib		throughout the study	No
Secondary	To compare safety and tolerability of nilotinib and imatinib		at month 1 and then every 3 months	Yes