Last updated: 11/03/2018 21:50:41
This product has been transferred to Novartis. GSK Clinical Study Register is no longer maintained for this study.
ECHO Analyses From Randomized Controlled Trials of Dabrafenib to Evaluate the Potential for Cardiac Valve Abnormalities
GSK study ID
201709
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
No longer a GSK study
No longer a GSK study
Trial overview
Official title: ECHO Analyses From Randomized Controlled Trials of Dabrafenib to Evaluate the Potential for Cardiac Valve Abnormalities
Trial description: An FDA post-marketing requirement (PMR) to further investigate independently reviewed echocardiogram (ECHO) results for subjects treated with dabrafenib, either as monotherapy or in combination with other anti-cancer therapies on randomized controlled clinical trials. These analyses will evaluate the potential for cardiac valve abnormalities in patients treated with dabrafenib based on preclinical findings.(TAFINLAR® is a trademark of the GlaxoSmithKline group of companies)
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Safety
Timeframe: Time Varied through 2020
Secondary outcomes:
None
Timeframe: NA
Interventions:
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
Other
Time perspective:
Other
Clinical publications:
Not applicable
Medical condition
Melanoma
Product
dabrafenib
Collaborators
Not applicable
Study date(s)
September 2013 to November 2020
Type
Observational
Phase
4
Participation criteria
Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable
- subjects treated with dabrafenib, either as monotherapy or in combination with other anti-cancer therapies on randomized controlled clinical trials
- Data from the following phase III randomized studies will be integrated: BRF113683/BREAK-3, MEK115306/COMBI-D, MEK116513/COMBI-V, BRF115532/COMBI-AD
- None
Inclusion and exclusion criteria
Inclusion criteria:
- subjects treated with dabrafenib, either as monotherapy or in combination with other anti-cancer therapies on randomized controlled clinical trials
- Data from the following phase III randomized studies will be integrated: BRF113683/BREAK-3, MEK115306/COMBI-D, MEK116513/COMBI-V, BRF115532/COMBI-AD
- Any additional GSK sponsored randomized study of dabrafenib either as monotherapy or in combination with other anti-cancer agents, which reaches the primary analysis endpoint during the reporting time period for each interim and final report will also be integrated.
- All analyses of the independently reviewed ECHO data will use the Safety population (SAFETY), which comprises all randomized subjects who received at least one dose of study medication and will be based on the actual treatment received if this differed from that to which the subject was randomized
- As the trials to be integrated are reported, the treatment arms to be used in analyses are as follows:
- Dabrafenib monotherapy (BREAK-3 + COMBI-D);
- MEK + Dabrafenib (COMBI-D+COMBI-V+COMBI-AD);
- DTIC (BREAK-3);
- Vemurafenib (COMBI-V); and
- Placebo (COMBI-AD)
Exclusion criteria:
- None
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
No longer a GSK study
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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