Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01735955
First received: November 14, 2012
Last updated: September 1, 2016
Last verified: September 2016
  Purpose
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 Intervention Phase
GIST and CML
Drug: AMN107
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Number of patients receiving nilotinib [ Time Frame: Until no patients are left on study up to 10 years ] [ Designated as safety issue: No ]
    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:
  • Frequency of serious adverse events [ Time Frame: Until no patients are left on study up to 10 years ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    To collect long term data on nature serious adverse events.


Enrollment: 45
Study Start Date: March 2013
Estimated Study Completion Date: December 2023
Estimated Primary Completion Date: December 2023 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AMN107 (nilotinib)
AMN107
Drug: AMN107
AMN107 (nilotinib)

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01735955

  Show 30 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01735955     History of Changes
Other Study ID Numbers: CAMN107A2409  2012-003902-28 
Study First Received: November 14, 2012
Last Updated: September 1, 2016
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
China: Food and Drug Administration
Denmark: Danish Medicines Agency
Hong Kong: Department of Health
Hungary: National Institute of Pharmacy
Japan: Pharmaceuticals and Medical Devices Agency
South Korea: Korea Food and Drug Administration (KFDA)
Singapore: Health Sciences Authority
Slovakia: State Institute for Drug Control
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Austria: Federal Office for Safety in Health Care
Brazil: National Health Surveillance Agency
Egypt: Ministry of Health and Population
Germany: Federal Institute for Drugs and Medical Devices
Israel: Ministry of Health
Italy: National Institute of Health
Netherlands: Ministry of Health, Welfare and Sport
Poland: Ministry of Health
Thailand: Food and Drug Administration
Taiwan: Department of Health

Keywords provided by Novartis:
Tasigna
CML
GIST
nilotinib

ClinicalTrials.gov processed this record on December 08, 2016