An Open Label Multi-center Extension Study to Evaluate Long-term Safety/ Tolerability of Dovitinib in Patients With Solid Tumors Who Continue to Receive Treatment With Dovitinib (TKI258) in Novartis-sponsored Single Agent Dovitinib Studies Which Fulfilled the Requirements for the Primary Objective

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Solid Tumors

Intervention / Treatment
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* Drug: dovitinib
* Drug: fulvestrant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patient was currently enrolled in Novartis sponsored study, which had met its endpoint and was receiving single agent oral dovitinib or dovitinib and fulvestrant coadministration patient was currently benefiting from treatment with single agent oral dovitinib or dovitinib and fulvestrant coadministration as determined by the guidelines of the parent protocol and according to the investigator's clinical judgment. patient had demonstated compliance patient had given written informed consent. Exclusion Criteria: patient had been permanently discontinued from oral dovitinib study treatment, either alone or in combination with fulvestrant, in the parent study patient was pregnant or nursing at the time of entry women of child-bearing potential and male patients with sexual partners of child-bearing potential unwilling to use highly effective methods of contraception during dosing and for a specified duration after stopping study treatment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dovitinib<br>Participants were given single agent dovitinib starting with last assigned dose and regimen which patient received in parent study. Additional dose modifications were given at the discretion of the investigator based on guidance provided in the protocol and investigative brochure (IB). | Drug: dovitinib<br>* Dovitinib was available in two formulations: capsules of 100 mg strength, and tablets of 100 mg strength and taken orally.<br>* Other names: TKI258;|
| Experimental: dovitinib + fulvestrant<br>Participants were given dovitinib and fulvestrant coadministration starting with last assigned dose and regimen which patient received in parent study. Additional dose modifications were at the discretion of the investigator based on guidance provided in the protocol and IB. | Drug: dovitinib<br>* Dovitinib was available in two formulations: capsules of 100 mg strength, and tablets of 100 mg strength and taken orally.<br>* Other names: TKI258;Drug: fulvestrant<br>* Fulvestrant is generally available as solution for injection in pre-filled syringes containing 250 mg of fulvestrant in 5 mL solution.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Until the last patient discontinued dovitinib up to 30 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nodule, solid tumors, TKI258, Dovitinib, fulvestrant, cancers with a mass, bulky tumor, lump, cancer, solid malignancies