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

• Sponsor: Novartis Pharmaceuticals (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT01735955
• Collaborator: (none)
• Enrollment: 57
• Locations: 33
• Arm: 1
• Anticipated Duration (Months): 121
• Patients Per Site: 1.7
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
GIST and CML	Drug: AMN107	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 57 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: Mar 29, 2013
• Anticipated Primary Completion Date: Apr 28, 2023
• Anticipated Study Completion Date: Apr 28, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AMN107 (nilotinib) AMN107	Drug: AMN107; AMN107 (nilotinib)

Outcome Measures

Primary Outcome Measures

1. Number of patients receiving nilotinib [Until no patients are left on study up to 10 years]

   To allow continued use of nilotinib to patients receiving nilotinib in a Novartis-sponsored Oncology CD&MA study which has reached its objectives and who are benefiting from treatment with nilotinib.

Secondary Outcome Measures

1. Frequency of serious adverse events [Until no patients are left on study up to 10 years]

   To collect long term data on serious adverse events.

2. Nature of serious adverse events [Until no patients are left on study up to 10 years]

   To collect long term data on nature serious adverse events.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York Oncology Hematology SC - 2	Albany	New York	United States	12208
2	University of Texas/MD Anderson Cancer Center SC - 5	Houston	Texas	United States	77030-4009
3	Novartis Investigative Site	Vienna		Austria	A-1090
4	Novartis Investigative Site	Vancouver	British Columbia	Canada	V5Z 4E6
5	Novartis Investigative Site	Halifax	Nova Scotia	Canada	B3H 1V7
6	Novartis Investigative Site	Hamilton	Ontario	Canada	L8V 5C2
7	Novartis Investigative Site	Toronto	Ontario	Canada	M5G1X5
8	Novartis Investigative Site	Lille		France	59000
9	Novartis Investigative Site	Paris		France	75571
10	Novartis Investigative Site	Hong Kong SAR		Hong Kong
11	Novartis Investigative Site	Budapest		Hungary	1062
12	Novartis Investigative Site	Budapest		Hungary	1097
13	Novartis Investigative Site	Haifa		Israel	3109601
14	Novartis Investigative Site	Bologna	BO	Italy	40138
15	Novartis Investigative Site	Genova	GE	Italy	16147
16	Novartis Investigative Site	Modena	MO	Italy	41124
17	Novartis Investigative Site	Roma	RM	Italy	00161
18	Novartis Investigative Site	Candiolo	TO	Italy	10060
19	Novartis Investigative Site	Suwon	Gyeonggi-do	Korea, Republic of	443380
20	Novartis Investigative Site	Seoul	Korea	Korea, Republic of	05505
21	Novartis Investigative Site	Seoul		Korea, Republic of	06351
22	Novartis Investigative Site	Amsterdam		Netherlands	1081 HV
23	Novartis Investigative Site	Leiden		Netherlands	2300 RC
24	Novartis Investigative Site	Moscow		Russian Federation	117198
25	Novartis Investigative Site	Singapore		Singapore	119228
26	Novartis Investigative Site	Singapore		Singapore	169608
27	Novartis Investigative Site	Bratislava		Slovakia	833 10
28	Novartis Investigative Site	Barcelona		Spain	08041
29	Novartis Investigative Site	Malmö		Sweden	SE-205 02
30	Novartis Investigative Site	Cambridge	London	United Kingdom	CB2 2QQ
31	Novartis Investigative Site	London		United Kingdom	SW3 6JJ
32	Novartis Investigative Site	Manchester		United Kingdom	M20 4BX
33	Novartis Investigative Site	Newcastle upon Tyne		United Kingdom	NE7 7DN

Sponsors and Collaborators

• Novartis Pharmaceuticals

Investigators

• Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novartis Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT01735955
• Other Study ID Numbers: CAMN107A2409; 2012-003902-28
• First Posted: Nov 28, 2012
• Last Update Posted: Jul 26, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Novartis Pharmaceuticals: Tasigna; CML; GIST; nilotinib

Study Results

No Results Posted as of Jul 26, 2022