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

An Open Label, Multi-center Nilotinib Roll-over Protocol for Patients Who Have Completed a Previous Novartis-sponsored Nilotinib Study and Are Judged by the Investigator to Benefit From Continued Nilotinib Treatment

ClinicalTrials.gov Identifier: NCT01735955

Novartis Reference Number: CAMN107A2409

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

The purpose of this study is to allow continued use of nilotinib in patients who are on nilotinib treatment in a Novartis-sponsored, Oncology Clinical Development & Medical Affairs (CD&MA) study and are benefiting from the treatment as judged by the investigator

Condition 
GIST and CML
Phase 
Phase 4
Overall status 
Recruiting
Enrollment count 
300 participants
Start date 
Mar 29, 2013
Completion date 
Apr 28, 2023
Gender 
All
Age(s)
(Child, Adult, Older Adult)

Interventions

Drug
AMN107
AMN107 (nilotinib)

Eligibility Criteria

Inclusion Criteria:

-Patient is currently enrolled in a Novartis-sponsored, Oncology Clinical Development & Medical Affairs study receiving nilotinib and has fulfilled all their requirements in the parent study -Patient is currently benefiting from the treatment with nilotinib, as determined by the investigator -Patient has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements -Willingness and ability to comply with scheduled visits, treatment plans and any other study procedures -Written informed consent obtained prior to enrolling in roll-over study

Exclusion Criteria:

- Patient has been permanently discontinued from nilotinib treatment in the parent study due to unacceptable toxicity, non-compliance to study procedures, withdrawal of consent or any other reason - Patient has participated in a Novartis sponsored combination trial where nilotinib was dispensed in combination with another study medication and patient is still receiving combination therapy -Patients who are currently receiving treatment with any medications that have the potential to prolong the QT interval or inducing Torsade de Pointes and the treatment cannot be either safely discontinued at least one week prior to nilotinib treatment or switched to a different medication prior to start of nilotinib treatment and for the duration of the study -Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hcG laboratory test. -Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during the study and for 30 days after the final dose of nilotinib.

Study Locations

United States
New York Oncology Hematology SC - 2
Completed
Albany, 12208
New York
United States
University of Texas/MD Anderson Cancer Center SC - 5
Recruiting
Houston, 77030-4009
Texas
United States
Austria
Novartis Investigative Site
Completed
Vienna, A-1090
-
Austria
Canada
Novartis Investigative Site
Completed
Vancouver, V5Z 4E6
British Columbia
Canada
Novartis Investigative Site
Terminated
Halifax, B3H 1V7
Nova Scotia
Canada
Novartis Investigative Site
Active, not recruiting
Hamilton, L8V 5C2
Ontario
Canada
Novartis Investigative Site
Active, not recruiting
Toronto, M5G1X5
Ontario
Canada
France
Novartis Investigative Site
Completed
Lille, 59000
-
France
Novartis Investigative Site
Completed
Paris, 75571
-
France
Hong Kong
Novartis Investigative Site
Completed
Hong Kong SAR,
-
Hong Kong
Hungary
Novartis Investigative Site
Completed
Budapest, 1062
-
Hungary
Novartis Investigative Site
Active, not recruiting
Budapest, 1097
-
Hungary
Israel
Novartis Investigative Site
Completed
Haifa, 3525408
-
Israel
Italy
Novartis Investigative Site
Completed
Bologna, 40138
BO
Italy
Novartis Investigative Site
Recruiting
Genova, 16147
GE
Italy
Novartis Investigative Site
Active, not recruiting
Modena, 41124
MO
Italy
Novartis Investigative Site
Completed
Roma, 00161
RM
Italy
Novartis Investigative Site
Completed
Candiolo, 10060
TO
Italy
Korea, Republic of
Novartis Investigative Site
Completed
Suwon, 443380
Gyeonggi-do
Korea, Republic of
Novartis Investigative Site
Completed
Seoul, 05505
Korea
Korea, Republic of
Novartis Investigative Site
Completed
Seoul, 06351
-
Korea, Republic of
Netherlands
Novartis Investigative Site
Active, not recruiting
Amsterdam, 1081 HV
-
Netherlands
Novartis Investigative Site
Completed
Leiden, 2300 RC
-
Netherlands
Russian Federation
Novartis Investigative Site
Active, not recruiting
Moscow, 117198
-
Russian Federation
Singapore
Novartis Investigative Site
Active, not recruiting
Singapore, 119228
-
Singapore
Novartis Investigative Site
Active, not recruiting
Singapore, 169608
-
Singapore
Slovakia
Novartis Investigative Site
Completed
Bratislava, 833 10
-
Slovakia
Spain
Novartis Investigative Site
Active, not recruiting
Barcelona, 08041
-
Spain
Sweden
Novartis Investigative Site
Completed
Malmö, SE-205 02
-
Sweden
United Kingdom
Novartis Investigative Site
Completed
Cambridge, CB2 2QQ
London
United Kingdom
Novartis Investigative Site
Completed
London, SW3 6JJ
-
United Kingdom
Novartis Investigative Site
Completed
Manchester, M20 9BX
-
United Kingdom
Novartis Investigative Site
Completed
Newcastle upon Tyne, NE7 7DN
-
United Kingdom

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
1-888-669-6682
Email: 
Name: 
Novartis Pharmaceuticals
Phone: 
+41613241111
Email: 

Have a question?

Call 1-999-669-6682 or email [email protected]