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 GSK Clinical Study Register is no longer maintained for this study.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
Observational study model:
Cohort
Primary completion date:
Not applicable
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)

No location data available.

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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