Study to Allow Access to Nilotinib for Patients Who Are on Nilotinib Treatment in a Novartis-sponsored Study
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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 |
- 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.
- 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.
| Estimated Enrollment: | 300 |
| Study Start Date: | March 2013 |
| Estimated Study Completion Date: | March 2023 |
| Estimated Primary Completion Date: | November 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: AMN107 (nilotinib)
AMN107
|
Drug: AMN107
AMN107 (nilotinib)
|
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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. Male patients must use highly effective contraception during the study and for 30 days after the final dose of nilotinib.
Contacts and Locations| Contact: Novartis Pharmaceuticals | 1-888-669-6682 | |
| Contact: Novartis Pharmaceuticals |
Show 34 Study Locations| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Novartis ( 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: | April 15, 2013 |
| 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 May 19, 2013