Last updated: 11/03/2018 21:50:49
This product has been transferred to Novartis. GSK Clinical Study Register is no longer maintained for this study.

Evaluation of Secondary Malignancies in Patients Treated with Dabrafenib in Randomized, Controlled Trials

GSK study ID
201710
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
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Evaluation of Secondary Malignancies in Patients Treated with Dabrafenib in Randomized, Controlled Trials
Trial description: An FDA post-marketing requirement (PMR) to further characterize secondary malignancies in subjects treated with dabrafenib, either as monotherapy or in combination with other anti-cancer therapies on randomized controlled clinical trials. (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:
  • Other: Not Applicable
    • 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 October 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 will use the Safety population (SAFETY) for each study, 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 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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