Solid Tumors Clinical Trial
Official title:
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
Verified date | January 2018 |
Source | Novartis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 12 |
Est. completion date | November 28, 2016 |
Est. primary completion date | November 28, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Austria | Novartis Investigative Site | Salzburg | |
Belgium | Novartis Investigative Site | Wilrijk | |
Denmark | Novartis Investigative Site | Copenhagen | |
Italy | Novartis Investigative Site | Pavia | PV |
Italy | Novartis Investigative Site | Torino | TO |
Japan | Novartis Investigative Site | Osaka-city | Osaka |
Spain | Novartis Investigative Site | Palma De Mallorca | Islas Baleares |
United States | Novartis Investigative Site | Bronx | New York |
United States | Novartis Investigative Site | Las Vegas | Nevada |
Lead Sponsor | Collaborator |
---|---|
Novartis Pharmaceuticals |
United States, Austria, Belgium, Denmark, Italy, Japan, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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