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

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ClinicalTrials.gov Identifier: NCT01735955
Recruitment Status : Recruiting
First Posted : November 28, 2012
Last Update Posted : July 15, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE November 14, 2012
First Posted Date  ICMJE November 28, 2012
Last Update Posted Date July 15, 2019
Actual Study Start Date  ICMJE March 29, 2013
Estimated Primary Completion Date April 28, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 29, 2012)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 21, 2012)
Number of patients receiving [ 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.
Change History Complete list of historical versions of study NCT01735955 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 21, 2012)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Allow Access to Nilotinib for Patients Who Are on Nilotinib Treatment in a Novartis-sponsored Study
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE GIST and CML
Intervention  ICMJE Drug: AMN107
AMN107 (nilotinib)
Study Arms  ICMJE Experimental: AMN107 (nilotinib)
AMN107
Intervention: Drug: AMN107
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 21, 2012)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 28, 2023
Estimated Primary Completion Date April 28, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals +41613241111
Listed Location Countries  ICMJE Italy,   Austria,   Canada,   France,   Hong Kong,   Hungary,   Israel,   Korea, Republic of,   Netherlands,   Russian Federation,   Singapore,   Slovakia,   Spain,   Sweden,   United Kingdom,   United States
Removed Location Countries Argentina,   China,   Germany,   Thailand
 
Administrative Information
NCT Number  ICMJE NCT01735955
Other Study ID Numbers  ICMJE CAMN107A2409
2012-003902-28 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP