Last updated: 11/03/2018 20:57:09
This product has been transferred to Novartis. GSK Clinical Study Register is no longer maintained for this study.

Dabrafenib Melanoma Named Patient Programme Chart ReviewDESCRIBE

GSK study ID
200775
See study documents
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: Dabrafenib Melanoma Named Patient Programme Chart Review
Trial description: Rationale: The purpose of this study is to understand the clinical outcomes and treatment patterns in patients who participated in the Named Patient Programme for dabrafenib in metastatic melanoma.
Objectives:
Primary Objectives
• Describe treatment patterns including systemic therapy, surgery, radiotherapy and any other interventions/procedures for patients with unresectable or metastatic melanoma who received dabrafenib monotherapy as compassionate use.
• Describe dabrafenib treatment duration.
Secondary Objectives
• Describe serious adverse events (SAEs) and AEs of special interest (AESI) during treatment with dabrafenib monotherapy.
• Determine best overall response (OR) for dabrafenib monotherapy.
• Determine progression-free survival (PFS) and overall survival (OS).
• Describe patterns of progression by location (brain, visceral and non-visceral) and by type of progression (tumour growth, new lesion(s) and clinical progression).
Data Source/Study Design: Data will be collected via retrospective review of patient medical records.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Dabrafenib treatment duration

Timeframe: From initiation to termination of dabrafenib therapy

Treatment patterns for patients with aSTS who received dabrafenib as compassionate use.

Timeframe: From initiation of first therapy to the last therapy recorded in the medical notes

Secondary outcomes:

Overall survival (OS) for dabrafenib

Timeframe: From initiation of dabrafenib until death

Serious adverse events (SAEs) and AEs of special interest (AESI) during treatment with dabrafenib monotherapy.

Timeframe: From initiation of dabrafenib until 28 days post dabrafenib termination

Type of progression (tumour growth, new lesion(s) and clinical progression).

Timeframe: at time of progression

Location of disease progression (brain, visceral and non-visceral).

Timeframe: At time of progression

Best overall response (OR) for dabrafenib

Timeframe: From initiation of dabrafenib until dabrafenib termination

Progression free survival (PFS) for dabrafenib

Timeframe: From initiation of dabrafenib until progression

Interventions:
  • Drug: Dabrafenib
    • Enrollment:
    300
    Primary completion date:
    Not applicable
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Not applicable
    Medical condition
    Melanoma
    Product
    dabrafenib
    Collaborators
    Not applicable
    Study date(s)
    March 2014 to October 2014
    Type
    Observational
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    none
    • Patient received at least one dose of dabrafenib as part of the Named Patient Programme at one of the participating study sites during the eligibility period (between 1 December 2010 and 1 August 2013).
    • Patient was 18 years of age or older at the time of enrolment into the Named Patient Programme.
    • Medical chart is missing, empty, or not retrievable.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Patient received at least one dose of dabrafenib as part of the Named Patient Programme at one of the participating study sites during the eligibility period (between 1 December 2010 and 1 August 2013).
    • Patient was 18 years of age or older at the time of enrolment into the Named Patient Programme.
    Exclusion criteria:
    • Medical chart is missing, empty, or not retrievable.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    No longer a GSK study
    Actual primary completion date
    Not applicable
    Actual study completion date
    2014-09-10

    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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