Randomized Phase Lll Study of Imatinib Dose Optimization vs Nilotinib in CML Patients With Suboptimal Response to Imatinib

PHASE3CompletedINTERVENTIONAL
Enrollment

191

Participants

Timeline

Start Date

May 31, 2009

Primary Completion Date

July 31, 2014

Study Completion Date

July 31, 2014

Conditions
Chronic Myelogenous Leukemia
Interventions
DRUG

nilotinib

Supplied as 200 mg tablets

DRUG

imatinib

Supplied as 100 mg and 400 mg tablets

Trial Locations (56)

1010

Novartis Investigative Site, Caracas

4004

Novartis Investigative Site, Maracaibo

8500

Novartis Investigative Site, Rio Negro

13353

Novartis Investigative Site, Berlin

14080

Novartis Investigative Site, Mexico City

45170

Novartis Investigative Site, Zapopan

64020

Novartis Investigative Site, Monterrey

100044

Novartis Investigative Site, Beijing

125167

Novartis Investigative Site, Moscow

129110

Novartis Investigative Site, Moscow

191024

Novartis Investigative Site, Saint Petersburg

197341

Novartis Investigative Site, Saint Petersburg

200025

Novartis Investigative Site, Shanghai

210029

Novartis Investigative Site, Nanjing

300020

Novartis Investigative Site, Tianjin

344090

Novartis Investigative Site, Rostov-on-Don

350001

Novartis Investigative Site, Fuzhou

380016

Novartis Investigative Site, Ahmedabad

400138

Novartis Investigative Site, Volgograd

500018

Novartis Investigative Site, Hyderabad

603126

Novartis Investigative Site, N.Novgorod

610041

Novartis Investigative Site, Chengdu

614068

Novartis Investigative Site, Perm

620102

Novartis Investigative Site, Yekaterinburg

632004

Novartis Investigative Site, Vellore

680022

Novartis Investigative Site, Krasnoyarsk

C1221ADC

Novartis Investigative Site, Caba

C1426ANZ

Novartis Investigative Site, Caba

B1900AWT

Novartis Investigative Site, La Plata

30130-100

Novartis Investigative Site, Belo Horizonte

78025-000

Novartis Investigative Site, Cuiaba

80060-900

Novartis Investigative Site, Curitiba

86015-520

Novartis Investigative Site, Londrina

20211-030

Novartis Investigative Site, Rio de Janeiro

20230-130

Novartis Investigative Site, Rio de Janeiro

91350-200

Novartis Investigative Site, Porto Alegre

88034-000

Novartis Investigative Site, Florianópolis

13083-970

Novartis Investigative Site, Campinas

17210-080

Novartis Investigative Site, Jaú

01224-000

Novartis Investigative Site, São Paulo

05403-000

Novartis Investigative Site, São Paulo

05651-901

Novartis Investigative Site, São Paulo

08270-070

Novartis Investigative Site, São Paulo

Unknown

Novartis Investigative Site, Bogota

Novartis Investigative Site, Montería

Novartis Investigative Site, Panama City

01010

Novartis Investigative Site, Guatemala City

560 095

Novartis Investigative Site, Bangalore

400 012

Novartis Investigative Site, Mumbai

014

Novartis Investigative Site, Mumbai 400 020

110 029

Novartis Investigative Site, New Delhi

02990

Novartis Investigative Site, Mexico City

06720

Novartis Investigative Site, Mexico City

06726

Novartis Investigative Site, Mexico City

31-501

Novartis Investigative Site, Krakow

50-367

Novartis Investigative Site, Wroclaw

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY