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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02039947
Registration number
NCT02039947
Ethics application status
Date submitted
19/12/2013
Date registered
20/01/2014
Date last updated
21/05/2019
Titles & IDs
Public title
Study to Evaluate Treatment of Dabrafenib Plus Trametinib in Subjects With BRAF Mutation-Positive Melanoma That Has Metastasized to the Brain
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Scientific 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
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Secondary ID [1]
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117277
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Melanoma and Brain Metastases
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Condition category
Condition code
Cancer
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Malignant melanoma
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Cancer
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Brain
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Dabrafenib
Treatment: Drugs - Trametinib
Experimental: Cohort A - Subjects will receive dabrafenib 150 milligram (mg) twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity.
Experimental: Cohort B - Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity
Experimental: Cohort C - Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity
Experimental: Cohort D - Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity
Treatment: Drugs: Dabrafenib
Dabrafenib will be provided as 50 mg and 75 mg capsules
Treatment: Drugs: Trametinib
Trametinib will be provided as 0.5 mg and 2.0 mg tablets
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Intracranial Response (IR) Rate in Cohort A
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Assessment method [1]
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The intracranial response rate is defined as the percentage of subjects achieving a confirmed intracranial CR or PR. This is based on investigator-assessed best intracranial response.
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Timepoint [1]
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From the start of treatment until disease progression or the start of new anti-cancer therapy
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Secondary outcome [1]
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Intracranial Response Rate of Cohorts B, C and D
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Assessment method [1]
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The intracranial response rate is defined as the percentage of subjects achieving a confirmed intracranial CR or PR. This is based on investigator-assessed best intracranial response. No hypothesis testing completed for cohort A, B,C and D
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Timepoint [1]
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Approximately 2 years
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Secondary outcome [2]
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Disease Control for Intracranial, Extracranial and Overall Response for Each Cohort
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Assessment method [2]
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Disease Control rate is defined as the percentage of subjects achieving a confirmed intracranial/extracranial/overall CR or PR or SD or Non-CR/Non-PD. This is based on investigator-assessed response. No hypothesis testing completed for cohort A, B,C and D
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Timepoint [2]
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Approximately 2 years
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Secondary outcome [3]
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Extracranial Response Rate (ER) for Each Cohort
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Assessment method [3]
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Extracranial Response Rate was defined as the percentage of participants with Complete response (CR) or Partial response (PR) at anytime. This is based on investigator-assessed response. No hypothesis testing completed for cohort A,B,C and D
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Timepoint [3]
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Approximately 2 years
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Secondary outcome [4]
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Overall Response (OR) for Each Cohort
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Assessment method [4]
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the number of subjects with a confirmed overall Complete response (CR) or Partial response (PR) by investigator assessment using the Response evaluation criteria in solid tumors (RECIST 1.1 criteria). To determine the overall response, all target and non-target lesions will be assessed using modified RECIST 1.1 criteria.
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Timepoint [4]
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Approximately 2 years
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Secondary outcome [5]
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Duration of Intracranial, Extracranial and Overall Response for Each Cohort
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Assessment method [5]
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Duration of intracranial, extracranial and overall response, are defined as the time from first documented evidence of CR or PR until time of first documented intracranial, extracranial, or overall disease progression. No hypothesis testing completed for cohort A,B,C and D
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Timepoint [5]
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From first documented evidence of CR or PR until time of first documented intracranial, extracranial, or overall disease progression
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Secondary outcome [6]
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Progression-free Survival (PFS) for Each Cohort Based on Investigator Assessment
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Assessment method [6]
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PFS is defined as the interval between first dose and the earliest date of disease progression or death due to any cause. No hypothesis testing completed for cohort A,B,C and D
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Timepoint [6]
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From the first dose to the earliest date of disease progression or death
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Secondary outcome [7]
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Overall Survival (OS) for Each Cohort
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Assessment method [7]
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Overall survival (OS) is defined as the time from the first dose until death due to any cause. No hypothesis testing completed for cohort A,B,C and D
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Timepoint [7]
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From the first dose to death
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
21/02/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
14/02/2018
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Sample size
Target
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Accrual to date
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Final
127
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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Novartis Investigative Site - North Sydney
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Recruitment hospital [2]
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Novartis Investigative Site - Greenslopes
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Recruitment hospital [3]
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Novartis Investigative Site - Melbourne
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Recruitment postcode(s) [1]
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2060 - North Sydney
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Recruitment postcode(s) [2]
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4120 - Greenslopes
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Recruitment postcode(s) [3]
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3004 - Melbourne
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Recruitment outside Australia
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United States of America
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Alabama
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California
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North Carolina
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Ohio
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Boulogne-Billancourt
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Lille
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Marseille Cedex 5
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Montpellier cedex 5
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Nantes Cedex 1
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Paris Cedex 10
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Bayern
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Thueringen
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Barcelona
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Las Palmas De Gran Canaria
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Pamplona
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Valencia
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Spain
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Zaragoza
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Novartis Pharmaceuticals
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02039947
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Novartis Pharmaceuticals
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Address
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Novartis Pharmaceuticals
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02039947
Download to PDF