Last updated: 11/03/2018 20:14:58
This product has been transferred to Novartis. GSK Clinical Study Register is no longer maintained for this study. The most up to date information is available on clinicaltrials.gov.

BRF117277: A Phase II, Open-Label, Multicentre Study of Dabrafenib plus Trametinib in Subjects with BRAF Mutation-Positive Melanoma that has Metastasized to the Brain

GSK study ID
117277
Clinicaltrials.gov ID
NCT02039947
EudraCT ID
2013-003452-21
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: BRF117277: A Phase II, Open-Label, Multicentre Study of Dabrafenib plus Trametinib in Subjects with BRAF Mutation-Positive Melanoma that has Metastasized to the Brain
Trial description: This is a multi-cohort, open label, Phase II study with Dabrafenib (GSK2118436) and Trametinib (GSK1120212) combination therapy in subject with BRAF mutation-positive melanoma that has metastasized to the brain. This study will evaluate the safety and efficacy of 4 cohorts. Cohorts will consist of; V600 E, D, K, R mutations, metastases to the brain, symptomatic and asymptomatic, with or without prior local (brain) therapy, with or without prior local (brain) therapy, and range of ECOG scores from 0-2.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

Intracranial response (IR) rate

Timeframe: Approximately 2 years

Secondary outcomes:

Intracranial response rate of cohorts B, C and D

Timeframe: Approximately 2 years

Disease Control for intracranial, extracranial and overall response for each cohort

Timeframe: Approximately 2 years

Extracranial response rate (ER) for each cohort

Timeframe: Approximately 2 years

Overall response (OR) for each cohort

Timeframe: Approximately 2 years

Duration of intracranial, extracranial and overall response for each cohort

Timeframe: Approximately 2 years

Progression-free survival (PFS) for each cohort

Timeframe: Approximately 2 years

Overall survival (OS) for each cohort

Timeframe: Approximately 2 years

Characterize the safety of dabrafenib and trametinib in combination therapy for all cohorts. Safety will be measured by the frequency and severity of adverse events, skin assessments, laboratory abnormalities, vital signs, and assessment data.

Timeframe: Approximately 2 years

Interventions:
Drug: Dabrafenib
Drug: Trametinib
Enrollment:
126
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Melanoma and Brain Metastases
Product
dabrafenib, dabrafenib/trametinib, trametinib
Collaborators
Not applicable
Study date(s)
February 2014 to June 2022
Type
Interventional
Phase
2/3

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
none
  • ECOG Performance Status range of 0-2
  • Histologically confirmed cutaneous metastatic melanoma of V600 E, K, D or R.
  • Prior treatment with any BRAF inhibitor or any mitogen-activated protein/extracellular signal–regulated kinase inhibitor.
  • Anti-cancer therapy or investigational anti-cancer therapy or chemotherapy without delayed toxicity within treatment specific timeframe.
Inclusion and exclusion criteria
Inclusion criteria:
  • ECOG Performance Status range of 0-2
  • Histologically confirmed cutaneous metastatic melanoma of V600 E, K, D or R.
  • May be systemic naïve or received up to two previous systemic treatment regimens for metastatic melanoma.
  • Must be able to undergo MRI and have at least one measurable intracranial lesion for which specific criteria have to be met.
Exclusion criteria:
  • Prior treatment with any BRAF inhibitor or any mitogen-activated protein/extracellular signal–regulated kinase inhibitor.
  • Anti-cancer therapy or investigational anti-cancer therapy or chemotherapy without delayed toxicity within treatment specific timeframe.
  • Treatment with stereotactic radiosurgery or treatment with whole-brain radiation within treatment specific timeframe.
  • Any presence of leptomeningeal disease or any parenchymal brain metastasis
  • History of another malignancy, some exceptions may apply.
  • A history or evidence of cardiovascular risk- specific criteria have to be met
  • A history or current evidence/risk of retinal vein occlusion or retinal pigment epithelial detachment
  • specific criteria have to be met.

Trial location(s)

No location data available.

Study documents

No study documents available.

Results overview

Study Results yet to be posted

Recruitment status
No longer a GSK study
Actual primary completion date
Not applicable
Actual study completion date
Not applicable

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

Additional information
Not applicable
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