Clinical trial · Interventional
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
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| dovitinib | Drug | Dovitinib | ALIAS |
| fulvestrant | Drug | Fulvestrant | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- dovitinib
- description
- Participants were given single agent dovitinib starting with last assigned dose and regimen which patient received in parent study. Additional dose modifications were given at the discretion of the investigator based on guidance provided in the protocol and investigative brochure (IB).
- interventionNames
- Drug: dovitinib
- type
- EXPERIMENTAL
- label
- dovitinib + fulvestrant
- description
- Participants were given dovitinib and fulvestrant coadministration starting with last assigned dose and regimen which patient received in parent study. Additional dose modifications were at the discretion of the investigator based on guidance provided in the protocol and IB.
- interventionNames
- Drug: dovitinib
- Drug: fulvestrant
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available