To provide continued treatment with trametinib.
ID
Source
Brief title
Condition
- Respiratory tract neoplasms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
None.
Secondary outcome
None.
Background summary
Study MEK114653 is a multicenter randomized open-label phase II parallel group
study comparing treatment with GSK1120212 (trametinib, a MEK-inhibitor) with
standard treatment with docetaxel in patients with non-small cell lung cancer
(NSCLC) stage IIIB or IV with KRAS, NRAS, BRAF of MEK1 mutation.
During a regular interim-analysis it was concluded that the totality of data
did not favour trametinib. Therefore the sponsor decided to discontinue
trametinib-arm of the study. Patients benefitting from trametinib can proceed
with this treatment in a roll-over study.
In the Netherlands only one patient from the study is still on treatment with
trametinib. This will be the only Dutch patient that will be enrolled in the
roll-over study. The sole objective of Dutch participation in this study is to
enable this patient to continue with trametinib.
Study objective
To provide continued treatment with trametinib.
Study design
Open non-comparative phase II study. Treatment with trametinib as monotherapy
or in combination.
Treatment duration as long as the patient has clinical benefit from.
Intervention
Treatment with trametinib.
Study burden and risks
Risk: Adverse effects of study medication.
Belasting: Visits every 3 weeks.
Blood draws every visit (during the first 2 years of treatment with
trametinib), approx. 10 mL/occasion.
ECG every 9 weeks (during the first 2 years of treatment with trametinib).
MUGA scan every 9 week.
No participation in sub-studies in the Netherlands.
Huis ter Heideweg 62
Zeist 3705 LZ
NL
Huis ter Heideweg 62
Zeist 3705 LZ
NL
Listed location countries
Age
Inclusion criteria
• Currently participating in trametinib study and is receiving treatment with trametinib.
• Currently receiving clinical benefit as determined by the investigator from previous treatment with trametinib either as monotherapy or as part of a combination treatment regimen.
Exclusion criteria
• Local access to commercially available GSK1120212.
• Current use of a prohibitive medication(s) as listed in the protocol (section 6.2).
• Bazett-corrected interval >=501 msec at the time of transition to this study.
• LVEF < institutional lower limit of normal.
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 n.n.b. |
| EudraCT | EUCTR2010-023015-33-NL |
| CCMO | NL43632.042.13 |