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Phase 4 N=57 Treatment

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

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

Enrolled (actual)
57
Serious AEs
29.8%
Results posted
Feb 2024
Primary outcome: Primary: Number of Participants With Adverse Events and Serious Adverse Events — 29; 15; 17; 2 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Nilotinib (Drug)
Age
Pediatric, Adult, Older Adult
Sex
All
Sponsor
Novartis Pharmaceuticals
Primary completion
Jul 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With Adverse Events and Serious Adverse Events
29; 15; 17; 2; 3; 3
SECONDARY
Number of Participants With Clinical Benefit From Nilotinib
15; 11; 17; 11; 19; 23

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

Eligibility 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01735955). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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