To collect long term data on safety and tolerability of dovitinib monotherapy.
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Adverse events.
Secondary outcome
None.
Background summary
This is an extension study for subjects who have completed the study
CTKI258A2120.
By joining the study subjects can continue treatment with dovitinib. In this
study the long term effects of the drug dovitinib will be investigated. All
subjects will be treated with active study drug.
Study objective
To collect long term data on safety and tolerability of dovitinib monotherapy.
Study design
Multicenter phase III non-comparative extension study. Continuation of the
dovitinib dose from the previous study. Dose adjustment possible.
Treatment period until unacceptable side effects, withdrawal of consent or lack
of benefit from treatment.
At least 25 patients.
Intervention
Treatment with dovitinib.
Study burden and risks
Risk: Adverse effects of study medication.
Burden: Visits every 4 weeks. Final visit 30 days post last dose of study
treatment. All visits: physical examination, blood tests (approx. 10 ml blood),
urine tests and ECG. At least every 16 weeks: tumor measurements. At start of
study: MUGA-scan or echocardiogram.
Raapopseweg 1
Arnhem 6824 DP
NL
Raapopseweg 1
Arnhem 6824 DP
NL
Listed location countries
Age
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | clinicaltrials.gov; registratienummer NCT02116803 |
| EudraCT | EUCTR2014-000368-17-NL |
| CCMO | NL49595.031.14 |