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
This trial has been completed.
|Phase||phase 2/phase 3|
|Targets||FGFR, CSF1R, FLT-3, KIT, PDGF, VEGF|
|Start date||May 2014|
|End date||November 2016|
|Trial size||12 participants|
|Trial identifier||NCT02116803, CTKI258A2X01B|
The study allows continued safety follow-up of patients who are on single agent dovitinib or dovitinib in combination with fulvestrant treatment in a Novartis-sponsored study which has met its primary endpoint and are benefiting from the treatment as judged by the investigator.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Las Vegas, NV||Comprehensive Cancer Centers||completed|
|Bronx, NY||Montefiore Medical Center-Weiler Hospital||no longer recruiting|
|Bronx, NY||Montefiore Medical Center SC - TKI258A2X01B||completed|
|Salzburg, Austria||Novartis Investigative Site||completed|
|Wilrijk, Belgium||Novartis Investigative Site||completed|
|Copenhagen, Denmark||Novartis Investigative Site||completed|
|Pavia, Italy||Novartis Investigative Site||completed|
|Torino, Italy||Novartis Investigative Site||completed|
|Osaka-city, Japan||Novartis Investigative Site||completed|
|Palma De Mallorca, Spain||Novartis Investigative Site||completed|
|Intervention model||parallel assignment|
Incidence and severity of adverse events
time frame: Until the last patient discontinues dovitinib; anticipated 2 years
All participants at least 18 years old.
- patient is currently enrolled in Novartis sponsored study, which has met its endpoint and is receiving single agent oral dovitinib or dovitinib and fulvestrant coadministration
- patient is 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 has demonstated compliance
- patient has given written informed consent.
- patient has been permanently discontinued from oral dovitinib study treatment, either alone or in combination with fulvestrant, in the parent study
- patient is 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 Other protocol-defined inclusion/exclusion criteria may apply
|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|
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