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

Completed · Phase 4

Conditions studied: Chronic Myelogenous Leukemia (CML), Metastatic Gastrointestinal Stromal Tumors (GIST), Acute Lymphoblastic Leukemia (ALL), Receptor Tyrosine Kinase (KIT) Mutated Melanoma

In brief

The purpose of this study was to allow continued use of nilotinib in patients who were on nilotinib treatment in a Novartis-sponsored, Oncology Clinical Development \& Medical Affairs (CD\&MA) study and were benefiting from the treatment as judged by the investigator

Key facts

Study ID

NCT01735955

Run by

Novartis Pharmaceuticals

People needed

57

Starts

2013-03-29

Expected to finish

2023-07-07

Last updated by the study team

2024-02-08

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Novartis Investigative Site — Albany, New York, United States
• Novartis Investigative Site — Houston, Texas, United States
• Novartis Investigative Site — Vienna, Austria
• Novartis Investigative Site — Vancouver, British Columbia, Canada
• Novartis Investigative Site — Halifax, Nova Scotia, Canada
• Novartis Investigative Site — Hamilton, Ontario, Canada
• Novartis Investigative Site — Toronto, Ontario, Canada
• Novartis Investigative Site — Lille, France
• Novartis Investigative Site — Paris, France
• Novartis Investigative Site — Hong Kong SAR, Hong Kong
• Novartis Investigative Site — Budapest, Hungary
• Novartis Investigative Site — Budapest, Hungary
• Novartis Investigative Site — Haifa, Israel
• Novartis Investigative Site — Bologna, BO, Italy
• Novartis Investigative Site — Genova, GE, Italy
• Novartis Investigative Site — Modena, MO, Italy
• Novartis Investigative Site — Roma, RM, Italy
• Novartis Investigative Site — Candiolo, TO, Italy
• Novartis Investigative Site — Amsterdam, Netherlands
• Novartis Investigative Site — Leiden, Netherlands
• Novartis Investigative Site — Moscow, Russia
• Novartis Investigative Site — Singapore, Singapore
• Novartis Investigative Site — Singapore, Singapore
• Novartis Investigative Site — Bratislava, Slovakia
• Novartis Investigative Site — Suwon, Gyeonggi-do, South Korea

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.