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

Completed · Phase 2/Phase 3

Conditions studied: Solid Tumors

In brief

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.

Key facts

Study ID

NCT02116803

Run by

Novartis Pharmaceuticals

People needed

12

Starts

2014-05-28

Expected to finish

2016-11-28

Last updated by the study team

2018-03-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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