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
Other
Other
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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
    Primary completion date:
    2015-24-07
    Observational study model:
    Cohort
    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)

    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
    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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