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
| Status: | Completed |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/17/2018 |
| Start Date: | May 28, 2014 |
| End Date: | November 28, 2016 |
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
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.
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.
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
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