Primary: To allow continued use of panobinostat to patients receiving single agent therapy with panobinostat in a Novartis-sponsored study.Secondary: To collect long term data on SAEs.
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
NA.
Secondary outcome
SAEs.
Background summary
This is an extension study for subjects who have completed the study
CLBH589X2105 (A phase I, open label, multi-center study to evaluate the
pharmacokinetics and safety of oral panobinostat in patients with advanced
solid tumors and varying degrees of renal function).
By joining the study subjects can continue treatment with panobinostat. In this
study the long term effects of the drug will be investigated. All subjects will
be treated with active study drug.
Study objective
Primary: To allow continued use of panobinostat to patients receiving single
agent therapy with panobinostat in a Novartis-sponsored study.
Secondary: To collect long term data on SAEs.
Study design
Multicenter phase II non-comparative extension study. Continuation of the
panobinostat dose during previous study. Dose adjustment possible.
Treatment period until unacceptable side effects, withdrawal of consent or lack
of benefit from treatment, max. 5 years.
Approx. 8-15 patients (1 in NL).
Intervention
Treatment with panobinostat.
Study burden and risks
Risk: Adverse effects of study medication.
Burden: Study duration max 5 years. Visits every 3 months. Final visit 30 days
post last dose of study treatment. No study related tests and procedures
required (investigator judgement).
Raapopseweg 1
Arnhem 6824 DP
NL
Raapopseweg 1
Arnhem 6824 DP
NL
Listed location countries
Age
Inclusion criteria
* Patient is currently enrolled in a Novartis-sponsored, Oncology Clinical Development & Medical Affairs study receiving single agent panobinostat and has fulfilled all their requirements in the parent study.
* Patient is currently benefiting from the treatment with single agent panobinostat, as determined by the investigator.
Exclusion criteria
* Patient has been permanently discontinued from panobinostat study treatment in the parent study due to unacceptable toxicity, non-compliance to study procedures, withdrawal of consent or any other reason.
* Patient has participated in a Novartis sponsored combination trial where panobinostat was dispensed in combination with another study medication and is still receiving combination therapy.
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 | clinical trials.gov; NCT01802879 |
| EudraCT | EUCTR2012-005252-41-NL |
| CCMO | NL48997.058.14 |