TRIAL DETAIL

Phase III, Open-Label Study of Nilotinib Versus Imatinib in GIST Patients (ENESTg1)

Drug:
Trial Name:
Phase III, Open-Label Study of Nilotinib Versus Imatinib in GIST Patients (ENESTg1)
NCT#:
Conditions:
Gastrointestinal Stromal Tumor
Status:
Completed
Phase:
3
Start Date 03/01/2009
Age of Trial (yrs) 12.8
Treatment Phase:
First-line
Drug Category:
KIT/PDGFRA inhibitor
Strategy:
Block KIT
Trial Type:
Specifically GIST and only GIST
Other Protocol IDs:
AMN107G2301 ENESTg1
Sponsor:
Novartis
Patient Contact:
Novartis Pharmaceuticals
Contact email:
Contact Phone:
+1-800-340-6843
Randomized:
Randomized
IV or Oral:
Oral
Trial Notes:
April 11, 2011
Novartis discontinues clinical trial of Tasigna® for investigational use in newly diagnosed patients with unresectable and/or metastatic GIST

* Independent data monitoring committee recommends stopping ENESTg1 trial as interim efficacy results show Tasigna is unlikely to show superiority.

This phase 3 trial tested whether nilotinib (also known as AMN107 and Tasigna) given as initial treatment for metastatic GIST is better than the current initial therapy, imatinib (Gleevec).
Patients entering the trial were randomized to receive either imatinib or nilotinib.

Both nilotinib and imatinib are made by the trial sponsor, Novartis.
Inclusion Criteria:

1. Histologically confirmed diagnosis of GIST which is unresectable and/or metastatic and either:
* no prior therapy with imatinib or any investigational therapies (e.g .sunitinib). Note: newly diagnosed patients may have received up to 14 days imatinib treatment for disease management while awaiting study start.
* recurrent GIST after stopping adjuvant treatment with imatinib and no subsequent treatment with any other investigational therapies (for example sunitinib).
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. Prior treatment with nilotinib or any other drug in this class or other targeted therapy agents with the exception of adjuvant imatinib.
2. Disease progression during adjuvant therapy with imatinib
3. Prior or concommitant malignancy that is currently clinically significant or currently requires active intervention.
4. Impaired cardiac function

Other protocol-defined inclusion/exclusion criteria may apply

Trial Links

 

Trial Results

 
 

Drug Information

Trial Sites

Name
Address
City
State
Zip
Country
Little Rock
AR
72205
USA
1500 E. Duarte Road
Duarte
CA
91010
USA
Pasadena
CA
91105
USA
875 Blake Wilbur Drive
Palo Alto
CA
94304
USA
La Jolla
CA
92093
USA
10945 Le Conte Ave.
Los Angeles
CA
90095
USA
1665 N. Ursula St.
Aurora
CO
80045
USA
675 North St. Clair
Chicago
IL
60611
USA
Westwood
KS
66205
USA
Baltimore
MD
21231
USA
450 Brookline Ave
Boston
MA
02215-5450
USA
1500 East Medical Center Dr
Ann Arbor
MI
48109
USA
Philadelphia
PA
19104
USA
Chiba
277-8577
Japan
Shizuoka
411-8777
Japan
Aichi
464-8681
Japan
Hokkaido
Japan
Singapore
Singapore
Singapore
119074
Singapore
Panorama
South Africa
Pretoria
South Africa
Pretoria
Gauteng
South Africa
Johannesburg
Gauteng
South Africa
Madrid
28046
Spain
Barcelona
08208
Spain
Bangkok
10330
Thailand
Songkla
90110
Thailand
Khon Kaen
40002
Thailand
Bangkok
10700
Thailand
Pittsburgh
PA
15232
USA
Bethlehem
PA
18015
USA
1505 Holcombe Blvd.
Houston
TX
77030
USA
Dallas
TX
75390
USA
Dallas
TX
75390
USA
Wauwatosa
WI
53226
USA
Vienna
Austria
Sao Paulo/SP
Brazil
Uberlandia/MG
Brazil
Ottawa
ON
K1H 8L6
Canada
Montreal
QC
H1T 2M4
Canada
Pareira
Colombia
Bogota
Colombia
Monteria
Colombia
Birmingham
B9 5SS
UK
197 Fulham Rd.
London
SW3 6JJ
UK
Glasgow
G12 0YN
UK
Arhus
8000
Denmark
Innrain 52
Innsbruck
6020
Austria
Florianopolis
Brazil
Campinas
Brazil
Santa Minica Uberlandia
Brazil
Sao Paulo
Brazil
Quebec City
QC
G1R 2J6
Canada
Hamilton
ON
L8V 5C2
Canada
London
ON
N6A 4L6
Canada
Sherbrooke
QC
J1H 5N4
Canada
Montreal
QC
H2L 4M1
Canada
Chuo-ku
Tokyo
104-0045
Japan
Osaka
540-0006
Japan
Okayama
701-0192
Japan
Kumamoto
860-8556
Japan
Miyagi
980-8574
Japan
Niigata
951-8520
Japan
Kanagawa
241-0815
Japan
Osaka
565-0871
Japan
600 University Ave.
Toronto
ON
M5G 1X5
Canada
550 Wilmslow Rd
Manchester
Lancashire
M20 4BX
UK
London
NW1 2PG
UK
Graz
Austria
Villejuif
Val de Narne
94805
France
28 rue Laennec
Lyon
Rhone
69373
France
Marseille
13000
France
Fukuoka City
Japan
Cambridge
CB2 OQQ
UK
Denver
CO
80218
USA
Ocala
FL
34471
USA
Athens
GA
30607
USA
2003 Lincoln Way
Coeur d'Alene
ID
83814
USA
Philadelphia
PA
19106
USA
Tyler
TX
75702
USA
Leiden
2333
Netherlands
Rahat
52621
Israel
Newcastle,
UK