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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01735955
Recruitment Status : Active, not recruiting
First Posted : November 28, 2012
Last Update Posted : May 23, 2023
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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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: Nilotinib Phase 4

Study Design
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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 : June 28, 2023
Estimated Study Completion Date : June 28, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Nilotinib

Arms and Interventions
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Arm Intervention/treatment
Experimental: Nilotinib
All participants who were on nilotinib treatment in a Novartis-sponsored study and were benefiting from the treatment as judged by the investigator, will receive nilotinib at the starting dose of the parent study. After this, the dose of nilotinib is based on the investigator's judgment.
 Drug: Nilotinib
Nilotinib can be provided as 200 mg and 150 mg hard gelatin capsules for oral use. Additional strengths of nilotinib can be provided if specified in the parent protocol. The starting dose of nilotinib should be the same as the last dose that was given in the parent nilotinib study. After this, the dose of nilotinib is based on the investigator's judgment.
Other Name: AMN107


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of participants with Adverse events and serious adverse events [ Time Frame: Until no patients are left on study up to 10 years ]
    Percentage of participants with Adverse events and serious adverse events


Secondary Outcome Measures :
  1. Percentage of participants with clinical benefit [ Time Frame: Until no patients are left on study up to 10 years ]
    Percentage of participants with clinical benefit as assessed by the investigator at scheduled visits


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01735955


Locations
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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, 3109601
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
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01735955    
Other Study ID Numbers: CAMN107A2409
2012-003902-28 ( EudraCT Number )
First Posted: November 28, 2012    Key Record Dates
Last Update Posted: May 23, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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