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

• ClinicalTrials.gov Identifier: NCT01735955
• Recruitment Status: Active, not recruiting
• First Posted: November 28, 2012
• Last Update Posted: May 7, 2021
• Sponsor: Novartis Pharmaceuticals
• Information provided by (Responsible Party): Novartis ( Novartis Pharmaceuticals )

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 (Clinical Trial)
• 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: March 29, 2013
• Estimated Primary Completion Date: April 28, 2023
• Estimated Study Completion Date: April 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Until no patients are left on study up to 10 years ]
   To collect long term data on nature serious adverse events.

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, New York

New York Oncology Hematology SC - 2

Albany, New York, United States, 12208

United States, Texas

University of Texas/MD Anderson Cancer Center SC - 5

Houston, Texas, United States, 77030-4009

Austria

Novartis Investigative Site

Vienna, Austria, A-1090

Canada, British Columbia

Novartis Investigative Site

Vancouver, British Columbia, Canada, V5Z 4E6

Canada, Nova Scotia

Novartis Investigative Site

Halifax, Nova Scotia, Canada, B3H 1V7

Canada, Ontario

Novartis Investigative Site

Hamilton, Ontario, Canada, L8V 5C2

Novartis Investigative Site

Toronto, Ontario, Canada, M5G1X5

France

Novartis Investigative Site

Lille, France, 59000

Novartis Investigative Site

Paris, France, 75571

Hong Kong

Novartis Investigative Site

Hong Kong SAR, Hong Kong

Hungary

Novartis Investigative Site

Budapest, Hungary, 1062

Novartis Investigative Site

Budapest, Hungary, 1097

Israel

Novartis Investigative Site

Haifa, Israel, 3525408

Italy

Novartis Investigative Site

Bologna, BO, Italy, 40138

Novartis Investigative Site

Genova, GE, Italy, 16147

Novartis Investigative Site

Modena, MO, Italy, 41124

Novartis Investigative Site

Roma, RM, Italy, 00161

Novartis Investigative Site

Candiolo, TO, Italy, 10060

Korea, Republic of

Novartis Investigative Site

Suwon, Gyeonggi-do, Korea, Republic of, 443380

Novartis Investigative Site

Seoul, Korea, Korea, Republic of, 05505

Novartis Investigative Site

Seoul, Korea, Republic of, 06351

Netherlands

Novartis Investigative Site

Amsterdam, Netherlands, 1081 HV

Novartis Investigative Site

Leiden, Netherlands, 2300 RC

Russian Federation

Novartis Investigative Site

Moscow, Russian Federation, 117198

Singapore

Novartis Investigative Site

Singapore, Singapore, 119228

Novartis Investigative Site

Singapore, Singapore, 169608

Slovakia

Novartis Investigative Site

Bratislava, Slovakia, 833 10

Spain

Novartis Investigative Site

Barcelona, Spain, 08041

Sweden

Novartis Investigative Site

Malmö, Sweden, SE-205 02

United Kingdom

Novartis Investigative Site

Cambridge, London, United Kingdom, CB2 2QQ

Novartis Investigative Site

London, United Kingdom, SW3 6JJ

Novartis Investigative Site

Manchester, United Kingdom, M20 4BX

Novartis Investigative Site

Newcastle upon Tyne, United Kingdom, NE7 7DN

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

• Study Director: Novartis Pharmaceuticals; Novartis Pharmaceuticals

More Information

• Responsible Party: Novartis Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT01735955
• Other Study ID Numbers: CAMN107A2409; 2012-003902-28 ( EudraCT Number )
• First Posted: November 28, 2012
• Last Update Posted: May 7, 2021
• Last Verified: May 2021

Individual Participant Data (IPD) Sharing Statement:

• 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 ( Novartis Pharmaceuticals ):

Tasigna; CML; GIST; nilotinib