Last updated: 02/03/2020 19:20:04
A Prospective Observational Study of Oral Oncolytic Therapies in Metastatic Melanoma Populations: A Post-Market Analysis of Utilization Patterns
GSK study ID
201355
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Cancelled
Cancelled
Trial overview
Official title: A Prospective Observational Study of Oral Oncolytic Therapies in Metastatic Melanoma Populations: A Post-Market Analysis of Utilization Patterns
Trial description: The goal of this study is to characterize the demographics, utilization patterns, duration of therapy (persistence), and healthcare resource utilization of subjects with metastatic melanoma receiving a BRAF- or MEK-targeted therapy from a specialty pharmacy. The information collected in this observational study will assist in the formation of individualized programs designed to maximize adherence, persistence, and outcomes for patients receiving therapy for metastatic melanoma. The primary objective of this study is to describe treatment patterns (therapy sequencing, adherence, and duration of therapy) in subjects receiving a BRAF-targeted kinase inhibitor (dabrafenib, vemurafenib) and/or a MEK-targeted kinase inhibitor (trametinib) from a specialty pharmacy. The secondary objectives are to characterize a subject's BRAF testing status and sites of metastasis prior to receiving one of the specified therapies, describe dose modifications and reasons for discontinuation across therapy cohorts, and describe healthcare resource utilization and pharmacy counseling events across therapy cohorts. The design of this study is prospective, observational cohort study. Data used in this study will be obtained from Diplomat Pharmacy, Inc. records, patient reports, and provider notes.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Treatment patterns
Timeframe: 12 months
Secondary outcomes:
Healthcare resource utilization
Timeframe: 12 months
BRAF testing status and sites of metastasis
Timeframe: 12 months
Dose modifications and discontinuation
Timeframe: 12 months
Demographics and subject characteristics
Timeframe: 12 months
Interventions:
Drug: trametinib and dabrafenib
Drug: dabrafenib
Drug: trametinib
Drug: vemurafenib
Enrollment:
0
Observational study model:
Cohort
Primary completion date:
2015-24-07
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Melanoma
Product
dabrafenib, dabrafenib/trametinib, trametinib, vemurafenib
Collaborators
Not applicable
Study date(s)
May 2014 to July 2015
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
none
- Receives therapy through Diplomat Specialty Pharmacy
- Age 18 years of age and older
- Patient is not able to provide informed consent regarding survey participation
- Patient has any other non-melanoma primary malignancy diagnosed within 6 months prior to starting the therapy of interest
Inclusion and exclusion criteria
Inclusion criteria:
- Receives therapy through Diplomat Specialty Pharmacy
- Age 18 years of age and older
- Diagnosed with malignant melanoma (International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) 172.x)
- Newly prescribed (no longer than 30 days since initiation of therapy) one the following: Dabrafenib 50 mg capsules (National Drug Code (NDC) 0173-0846-08) or 75 mg capsules (NDC 0173-0847-08),Trametinib 0.5 mg tablets (NDC 0173-0849-13), 1 mg tablets (NDC 0173-0858-13), or 2 mg tablets (NDC 0173-0848-13), Vemurafenib 240 mg film-coated tablets (NDC 50242-090-01), or Trametinib and Dabrafenib in combination
- Patient is able to read and understand English
- Patient is able to provide verbal (telephonic) informed consent
Exclusion criteria:
- Patient is not able to provide informed consent regarding survey participation
- Patient has any other non-melanoma primary malignancy diagnosed within 6 months prior to starting the therapy of interest
- Patient uses any of the therapies of interest in combination with other anti-cancer therapies, excluding the combination of trametinib and dabrafenib
Trial location(s)
No location data available.
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Cancelled
Actual primary completion date
2015-24-07
Actual study completion date
2015-24-07
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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