Last updated: 03/10/2020 14:40:12
Adherence to Dabrafenib plus Trametinib in subjects with BRAF V600 mutant unresectable or metastatic melanoma
GSK study ID
201431
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
Trial overview
Official title: Adherence to Dabrafenib plus Trametinib in subjects with BRAF V600 mutant unresectable or metastatic melanoma
Trial description: Adherence patterns to oral metastatic melanoma treatments are not well known. Therefore, there is a need for a prospective study that documents adherence in this subject population in routine clinical practice. The primary objective of this prospective, observational, multi-center, open-label, single group study is to describe medication adherence to and persistence with combination dabrafenib/trametinib therapy over a follow-up period of 12 months in adult subjects with BRAF V600 mutation positive unresectable or metastatic melanoma. Adherence will be measured by using a medication event monitoring system (MEMS) and manual pill count. All subjects enrolled in the study will be treated with dabrafenib/trametinib combination therapy as determined by their physician per usual care. All decisions regarding subject care including treatment, frequency of clinic visits, and assessment of clinical response, will be made by the treating physician. Subjects will also complete study specific questionnaires and Health Related Quality of life questionnaires
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Dose-taking adherence measured by MEMS and pill count (PC)
Timeframe: Up to 12 Months
Secondary outcomes:
Correlation coefficients between adherence or persistence and subject
Timeframe: Up to 12 Months
Interventions:
Enrollment:
0
Primary completion date:
Not applicable
Observational study model:
Case-Only
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Melanoma
Product
dabrafenib, trametinib
Collaborators
Not applicable
Study date(s)
May 2015 to August 2016
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
none
- Subjects >18 years of age
- Subjects with histologically confirmed BRAF V600 mutation positive unresectable or metastatic melanoma
- Current participation in any prospective (interventional or non-interventional) clinical study
- Subjects who are not capable of understanding and cooperating with the requirements of the study
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects >18 years of age
- Subjects with histologically confirmed BRAF V600 mutation positive unresectable or metastatic melanoma
- Subjects planning to initiate combination dabrafenib/trametinib treatment per usual care
Exclusion criteria:
- Current participation in any prospective (interventional or non-interventional) clinical study
- Subjects who are not capable of understanding and cooperating with the requirements of the study
- Subjects who are not willing to provide informed consent to participate in the study Subjects who are pregnant
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
Other
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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