The study allowed continued safety follow-up of patients who were on single agent dovitinib or dovitinib in combination with fulvestrant treatment in a Novartis-sponsored study which had met its primary endpoint and were benefiting from the treatment as judged by the investigator.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Dovitinib was available in two formulations: capsules of 100 mg strength, and tablets of 100 mg strength and taken orally.
Fulvestrant is generally available as solution for injection in pre-filled syringes containing 250 mg of fulvestrant in 5 mL solution.
Novartis Investigative Site
Las Vegas, Nevada, United States
Novartis Investigative Site
The Bronx, New York, United States
Novartis Investigative Site
Salzburg, Austria
Novartis Investigative Site
Wilrijk, Belgium
Novartis Investigative Site
Copenhagen, Denmark
Novartis Investigative Site
Pavia, PV, Italy
Novartis Investigative Site
Torino, TO, Italy
Novartis Investigative Site
Osaka, Osaka, Japan
Novartis Investigative Site
Palma de Mallorca, Balearic Islands, Spain
Number of Participants With Adverse Events of Grades 3 and 4 Severity
Participants with grades 3 and 4 severity adverse events were assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03, unless otherwise specified. AEs are provided by System Organ Class (SOC). A patient with multiple adverse events within a primary system organ class was counted only once in the total row.
Time frame: Until the last patient discontinued dovitinib up to 30 months
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