CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 57 enrolled
Drug / intervention
Nilotinibdrug
Likely dose
Nilotinib 800 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01735955
NCT01735955Phase 4Completed
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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

Novartis Pharmaceuticals·interventional·Posted Nov 28, 2012·Updated Feb 8, 2024

In Brief

A Phase 4 clinical trial evaluating Nilotinib for Chronic Myelogenous Leukemia (CML) and 3 related conditions. Completed, enrolled 57 participants across 33 sites in 16 countries.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Myelogenous Leukemia (CML), Metastatic Gastrointestinal Stromal Tumors (GIST), Acute Lymphoblastic Leukemia (ALL), Receptor Tyrosine Kinase (KIT) Mutated Melanoma
CountriesAustria, Canada, France, Hong Kong, Hungary, Israel, Italy, Netherlands, Russia, Singapore, Slovakia, South Korea, Spain, Sweden, United Kingdom, United States
Collaborators--

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedNov 28, 2012
Enrollment StartMar 29, 2013
Primary CompletionJul 7, 2023
TodayJul 2, 2026
Enrollment to primary: 10.3 yearsPosted 13.6 years ago

Interventions

Nilotinibdrug

Patients who were on nilotinib treatment in a Novartis-sponsored study (parent study) and were benefiting from nilotinib treatment met the criteria for enrolment into the CAMN107A2409 study and to receive continued nilotinib treatment. The starting dose of nilotinib in the CAMN107A2409 study should have been the same as the last dose administered in the parent study. After the starting dose, the dose of nilotinib was based on the investigator's judgement. The dose of nilotinib should have been ≤ 800 mg/day for adult patients, 230mg/m2 body surface area (BSA) and ≤ 800 mg/day for pediatric patients.