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
- 10027655solid tumors
- Registration Number
- NL-OMON41205
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 1
* Patients with solid tumors, who are currently receiving treatment with single agent dovitinib within a Novartis study which has fulfilled the requirements for the primary objective.
* Patient is currently benefiting from the treatment with single agent dovitinib, as determined by the investigator.
* Patient has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements
* Concurrent severe and/or uncontrolled concomitant medical conditions that could cause unacceptable safety risks or compromise compliance with the protocol
* Unresolved toxicities for which study drug dosing has been interrupted in the parent study.
* Pregnancy, lactation.
* Fertile males not willing to use safe contraception.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Adverse events.</p><br>
- Secondary Outcome Measures
Name Time Method <p>None.</p><br>