Last updated: 02/03/2020 19:00:16

PGx6039 PGx Investigation of Pyrexia in Subjects Receiving GSK2118436 Monotherapy

GSK study ID
116604
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: PGx6039 PGx Investigation of Pyrexia in Subjects Receiving GSK2118436 Monotherapy
Trial description: Dabrafenib (GSK2118436) is a potent inhibitor of BRAF kinase, being developed for the treatment of BRAF V600 mutation positive metastatic melanoma and BRAF V600 mutation positive advanced non-small cell lung cancer (NSCLC).
Pyrexia, or fever, is one of the most common adverse events (AE) in subjects exposed to dabrafenib, and is observed in up to 1/3 of subjects receiving this drug. The majority of these AEs are transient and resolve after treatment interruption, while a small proportion (2-5%) of subjects develops serious non-infectious febrile events such as influenza-like illness, cytokine release syndrome, and systemic inflammatory response syndrome which may require extensive management. The underlying mechanism for development of pyrexia on treatment with dabrafenib is not clear.
This study aims to identify germline genetic variants that may be associated with the development of pyrexia in subjects receiving dabrafenib, using data from three metastatic melanoma studies (BRF113710, BRF113929 and BRF113683).
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

In a meta-analysis of the metastatic melanoma subjects from BRF113710, BRF113929 and BRF113683 studies, identify germline genetic variants (from candidate genes, HLA region or whole genome scan) that may associate with development of pyrexia in subjects

Timeframe: N/A

Secondary outcomes:
Not applicable
Interventions:
  • Drug: dabrafenib (GSK2118436)
    • Enrollment:
    0
    Primary completion date:
    2012-05-10
    Observational study model:
    Case-Control
    Time perspective:
    Retrospective
    Clinical publications:
    Not applicable
    Medical condition
    Melanoma and Brain Metastases
    Product
    dabrafenib
    Collaborators
    Not applicable
    Study date(s)
    March 2012 to October 2012
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable
    Accepts healthy volunteers
    none
    • Patients that provided written informed consent for PGx research when they enrolled in the clinical studies BRF113710, BRF113929 and BRF113683 and did not withdraw consent prior to PGx experiment
    • Patients that provided a blood sample for genotyping
    • Patients that did not provide written informed consent for PGx research when they enrolled in the clinical studies BRF113710, BRF113929 and BRF113683 or withdrew their PGx consent prior to genotyping being conducted
    • Patients that did not provide any or an adequate blood sample for genotyping
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Patients that provided written informed consent for PGx research when they enrolled in the clinical studies BRF113710, BRF113929 and BRF113683 and did not withdraw consent prior to PGx experiment
    • Patients that provided a blood sample for genotyping
    • Patients that successfully genotyped for at least one of the genetic variants under study and passed quality control measures
    • Patients with valid clinical data available
    Exclusion criteria:
    • Patients that did not provide written informed consent for PGx research when they enrolled in the clinical studies BRF113710, BRF113929 and BRF113683 or withdrew their PGx consent prior to genotyping being conducted
    • Patients that did not provide any or an adequate blood sample for genotyping
    • Patients that failed genotyping for all of the genetic variants under study
    • Patients that did not have valid clinical data available

    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
    Study complete
    Actual primary completion date
    2012-05-10
    Actual study completion date
    2012-05-10

    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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