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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/NCT01765556
Registration number
NCT01765556
Ethics application status
Date submitted
9/01/2013
Date registered
10/01/2013
Date last updated
2/11/2016
Titles & IDs
Public title
A Pharmacokinetics Study to Investigate the Effect of Ketoconazole on Vemurafenib in Patients With BRAFV600 Mutation-Positive Metastatic Melanoma
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Scientific title
A Phase I, Open-Label, Multicenter, Three-Period, One-Sequence Study To Investigate The Effect Of Ketoconazole On The Pharmacokinetics Of A Single Oral Dose Of 960 Mg Of Vemurafenib
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Secondary ID [1]
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2012-003143-29
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Secondary ID [2]
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GO28054
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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:
Malignant Melanoma, Neoplasms
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Condition category
Condition code
Cancer
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Malignant melanoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - ketoconazole
Treatment: Drugs - vemurafenib
Experimental: Ketoconazole treatment -
Experimental: Vemurafenib treatment -
Treatment: Drugs: ketoconazole
multiple doses of ketoconazole in Period B and C
Treatment: Drugs: vemurafenib
single dose of vemurafenib in Period A and C
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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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Pharmacokinetics: Area under the concentration time curve
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Assessment method [1]
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Timepoint [1]
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Approximately 19 days
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Primary outcome [2]
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Pharmacokinetics: Maximum plasma concentration
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Assessment method [2]
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Timepoint [2]
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Approximately 19 days
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Primary outcome [3]
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Pharmacokinetics: Time to maximum plasma concentration
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Assessment method [3]
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Timepoint [3]
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Approximately 19 days
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Primary outcome [4]
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Pharmacokinetics: Terminal half-life
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Assessment method [4]
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Timepoint [4]
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Approximately 19 days
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Primary outcome [5]
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Pharmacokinetics: Apparent clearance
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Assessment method [5]
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Timepoint [5]
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Approximately 19 days
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Secondary outcome [1]
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Safety: Incidence of adverse events
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Assessment method [1]
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Timepoint [1]
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Approximately 19 days
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Eligibility
Key inclusion criteria
- Male or female patients >= 18 years old
- Patients with either unresectable Stage IIIc or Stage IV metastatic melanoma positive
for the BRAFV600 mutation or other malignant tumor type that harbors a V600-activating
mutation of BRAF, as determined by results of cobas® 4800 BRAF V600 mutation test or a
DNA sequencing method, and who have no acceptable standard treatment options
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Life expectancy >= 12 weeks
- Full recovery from the effects of any major surgery or significant traumatic injury
within 14 days prior to the first dose of study treatment
- Adequate hematologic and end organ function
- Female patients of childbearing potential and male patients with partners of
childbearing potential must agree to always use two effective methods of contraception
- Negative serum pregnancy test within 7 days prior to commencement of dosing in women
of childbearing potential
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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 vemurafenib or other BRAF inhibitor within 42 days of first dose
of study drug
- Requirement for immediate or urgent treatment with daily vemurafenib and for whom the
intermittent schedule of vemurafenib employed during the 19-day period for this trial
is not clinically acceptable
- Allergy or hypersensitivity to components of the vemurafenib formulation
- Experimental therapy within 4 weeks prior to first dose of study drug
- Major surgical procedure or significant traumatic injury within 14 days prior to first
dose of study drug or anticipation of the need for major surgery during study
treatment
- Prior anti-cancer therapy within 28 days before the first dose of study drug
- History of clinically significant cardiac or pulmonary dysfunction
- History of symptomatic congestive heart failure of any New York Heart Association
class or serious cardiac arrhythmia requiring treatment
- History of myocardial infarction within 6 months prior to first dose of study drug
- Current dyspnea at rest, owing to complications of advanced malignancy or any
requirement for supplemental oxygen to perform activities of daily living
- History of congenital long QT syndrome or QTc > 450 ms
- Active central nervous system lesions
- Uncontrolled or poorly controlled diabetes
- Current severe, uncontrolled systemic disease
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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
Single group
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Withdrawn
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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
1/10/2013
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Actual
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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
1/10/2013
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Actual
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Sample size
Target
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Hoffmann-La Roche
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This open-label, multi-center, three-period, one sequence study will investigate the effect
of ketoconazole on the pharmacokinetics of vemurafenib in patients with unresectable
BRAFV600-mutation positive metastatic melanoma or other malignant tumor type that harbors a
V600-activating mutation of BRAF without acceptable standard treatment options. Patients will
receive a single dose of vemurafenib in Periods A and C and multiple doses of ketoconazole in
Periods B and C. Eligible patients will have the option to continue treatment with
vemurafenib as part of an extension study (NCT01739764). The anticipated time on study
treatment is approximately 19 days.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01765556
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
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Clinical Trials
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Address
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Hoffmann-La Roche
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01765556
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