At a glance
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An Open Label, Multi-center, Extension Study to Evaluate Long-term Safety and Tolerability of Dovitinib in Patients With Solid Tumors, Who Continue to Receive Treatment With Dovitinib (TKI258) in Novartis-sponsored, Single Agent Dovitinib Studies, Which Have Fulfilled the Requirements for the Primary Objective, and Are Benefitting From Continued Dovitinib Treatment as Assessed by the Investigator
In Brief
A Phase 3 clinical trial evaluating dovitinib and fulvestrant for Solid Tumors. Completed, enrolled 12 participants across 9 sites in 7 countries.
Detailed Summary
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 Details
Timeline
Interventions
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.