Study to Allow Access to Nilotinib for Patients Who Are on Nilotinib Treatment in a Novartis-sponsored Study

PHASE4CompletedINTERVENTIONAL
Enrollment

57

Participants

Timeline

Start Date

March 29, 2013

Primary Completion Date

July 7, 2023

Study Completion Date

July 7, 2023

Conditions
Chronic Myelogenous Leukemia (CML)Metastatic Gastrointestinal Stromal Tumors (GIST)Acute Lymphoblastic Leukemia (ALL)Receptor Tyrosine Kinase (KIT) Mutated Melanoma
Interventions
DRUG

Nilotinib

Patients who were on nilotinib treatment in a Novartis-sponsored study (parent study) and were benefiting from nilotinib treatment met the criteria for enrolment into the CAMN107A2409 study and to receive continued nilotinib treatment. The starting dose of nilotinib in the CAMN107A2409 study should have been the same as the last dose administered in the parent study. After the starting dose, the dose of nilotinib was based on the investigator's judgement. The dose of nilotinib should have been ≤ 800 mg/day for adult patients, 230mg/m2 body surface area (BSA) and ≤ 800 mg/day for pediatric patients.

Trial Locations (33)

1062

Novartis Investigative Site, Budapest

1097

Novartis Investigative Site, Budapest

10060

Novartis Investigative Site, Candiolo

12208

Novartis Investigative Site, Albany

16147

Novartis Investigative Site, Genova

40138

Novartis Investigative Site, Bologna

41124

Novartis Investigative Site, Modena

59000

Novartis Investigative Site, Lille

75571

Novartis Investigative Site, Paris

77030

Novartis Investigative Site, Houston

117198

Novartis Investigative Site, Moscow

119228

Novartis Investigative Site, Singapore

169608

Novartis Investigative Site, Singapore

443380

Novartis Investigative Site, Suwon

3109601

Novartis Investigative Site, Haifa

A 1090

Novartis Investigative Site, Vienna

V5Z 4E6

Novartis Investigative Site, Vancouver

B3H 1V7

Novartis Investigative Site, Halifax

L8V 5C2

Novartis Investigative Site, Hamilton

M5G1X5

Novartis Investigative Site, Toronto

Unknown

Novartis Investigative Site, Hong Kong SAR

00161

Novartis Investigative Site, Roma

1081 HV

Novartis Investigative Site, Amsterdam

2300 RC

Novartis Investigative Site, Leiden

833 10

Novartis Investigative Site, Bratislava

05505

Novartis Investigative Site, Seoul

06351

Novartis Investigative Site, Seoul

08041

Novartis Investigative Site, Barcelona

SE-205 02

Novartis Investigative Site, Malmo

CB2 2QQ

Novartis Investigative Site, Cambridge

SW3 6JJ

Novartis Investigative Site, London

M20 4BX

Novartis Investigative Site, Manchester

NE7 7DN

Novartis Investigative Site, Newcastle upon Tyne

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY