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



Status:Recruiting
Healthy:No
Age Range:Any
Updated:3/15/2019
Start Date:March 29, 2013
End Date:April 28, 2023
Contact:Novartis Pharmaceuticals
Phone:1-888-669-6682

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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

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


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.
We found this trial at
3
sites
Houston, Texas 77030
Principal Investigator: Vinod Ravi
Phone: 713-563-0004
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Albany, New York 12208
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Vienna,
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