Overview

This trial is active, not recruiting.

Condition solid tumors
Treatments dovitinib, fulvestrant
Phase phase 2/phase 3
Targets FGFR, CSF1R, FLT-3, KIT, PDGF, VEGF
Sponsor Novartis Pharmaceuticals
Start date May 2014
End date November 2016
Trial size 12 participants
Trial identifier NCT02116803, CTKI258A2X01B

Summary

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

Study Design

Allocation non-randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
single agent dovitinib starting with last assigned dose and regimen which patient received in parent study. Additional dose modifications are at the discretion of the investigator based on guidance provided in the protocol and IB.
dovitinib TKI258
(Experimental)
dovitinib and fulvestrant coadministration starting with last assigned dose and regimen which patient received in parent study. Additional dose modifications are at the discretion of the investigator based on guidance provided in the protocol and IB.
fulvestrant

Primary Outcomes

Measure
Incidence and severity of adverse events
time frame: Until the last patient discontinues dovitinib; anticipated 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - 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. Exclusion Criteria: - 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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Novartis.
Location data was received from the National Cancer Institute and was last updated in September 2016.