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    The EU Clinical Trials Register currently displays   37210   clinical trials with a EudraCT protocol, of which   6120   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2011-000954-46
    Sponsor's Protocol Code Number:MO25743
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-07-14
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2011-000954-46
    A.3Full title of the trial
    An open-label, single-arm, phase II, multicenter study to evaluate
    the efficacy of vemurafenib in metastatic melanoma patients with brain metastases
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    This open-label study will assess the efficacy and safety of vemurafenib (RO5185426) in metastatic melanoma patients with untreated or treated brain metastases. Patients will receive vemurafenib (RO5185426) at a dose of 960 mg twice daily orally until disease progression or unacceptable toxicity occurs.
    A.3.2Name or abbreviated title of the trial where available
    NA (no short title)
    A.4.1Sponsor's protocol code numberMO25743
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorF. Hoffman-La Roche Ltd.
    B.1.3.4CountrySwitzerland
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportF.Hoffmann-La Roche Ltd.
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF.Hoffmann-La Roche Ltd.
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post codeCH-4070
    B.5.3.4CountrySwitzerland
    B.5.6E-mailglobal.rochegenentechtrials@roche.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code RO5185426/F17
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVemurafenib
    D.3.9.1CAS number 918504-65-1
    D.3.9.2Current sponsor codeRO5185426-006
    D.3.9.3Other descriptive nameRG7204, PLX4032
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number240
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Metastatic Melanoma with Brain Metastases
    E.1.1.1Medical condition in easily understood language
    Metastatic Melanoma with Brain Metastases
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10027481
    E.1.2Term Metastatic melanoma
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of vemurafenib using Best Overall
    Response Rate (BORR), as assessed by an Independent
    Review Committee (IRC) using Response Evaluation Criteria
    in Solid Tumors, Version 1.1 (RECIST, v1.1) in the brain of
    metastatic melanoma patients with previously untreated brain
    metastases
    E.2.2Secondary objectives of the trial
    • To evaluate the efficacy of vemurafenib using BORR in the brain of patients with previously treated or untreated brain metastases assessed by an IRC using RECIST v1.1 criteria
    • To evaluate the efficacy of vemurafenib using BORR in the brain of patients with previously-treated brain metastases as assessed by an IRC using RECIST v1.1 criteria
    • To evaluate the safety and tolerability of vemurafenib in patients with melanoma metastatic to the brain, as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE, v4.0)
    • To evaluate BORR outside of the brain as assessed by an IRC, duration of response (DOR) in and outside of the brain, progression-free survival (PFS), time to development of new brain metastases in responding patients, and overall survival (OS) in patients with melanoma metastatic to the brain
    • To evaluate the efficacy of vemurafenib using BORR in the brain and outside of the brain
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Adult patients, ≥ 18 years of age
    •Metastatic melanoma (Stage IV, American Joint Committee on Cancer) with BRAF V600 mutation (cobas 4800 BRAF V600 Mutation Test)
    •Measurable brain metastases, treated or untreated
    •Patients may or may not have received prior systemic therapy for metastatic melanoma and either a) have received no prior treatment for brain metastases or b) have received prior treatment for brain metastases and have progressed
    •Patients may or may not have symptoms related to their brain metastases
    •Eastern Cooperative Oncology Group (ECOG) performance status 0-1
    •Patients must have recovered from all side effects of their most recent systemic or local treatment for metastatic melanoma
    E.4Principal exclusion criteria
    •Increasing corticosteroid dose during the 7 days prior to first dose of study drug
    •Leptominingeal involvement in patients with no prior treatment for brain metastases (cohort 1). Leptomeningeal involvement is only allowed in patients with prior treatment for brain metastases (cohort 2)
    •Previous malignancy requiring active treatment within the past 2 years, except for treated and controlled basal or squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix
    •Concurrent administration of any anticancer therapies other than those administered in the study
    •Treatment with any cytotoxic and/or investigational cytotoxic drug or targeted therapy ≤ 4 weeks prior to first administration of vemurafenib and radiation therapy ≤ 1 weeks prior to first administration of vemurafenib and stereotactic radiotherapy ≤ 1 day prior to prior to first administration of vemurafenib.•Prior treatment with BRAF or MEK inhibitors
    •Clinically significant cardiovascular disease or event within the 6 months prior to first dose of study drug
    •History or presence of clinically significant cardiac dysrhythmia
    •Corrected QT interval ≥ 450 ms or history of congenital long QT syndrome
    E.5 End points
    E.5.1Primary end point(s)
    Best Overall Response Rate (BORR) in previously untreated brain metastases (assessed by Independent Review Committee using RECIST)
    E.5.1.1Timepoint(s) of evaluation of this end point
    June 2012
    E.5.2Secondary end point(s)
    •BORR in previously treated or untreated brain metastases (assessed by Independent Review Committee)
    •BORR in previously treated brain metastases (assessed by Independent Review Committee)
    •BORR outside of the brain (assessed by Independent Review Committee)
    •BORR in brain metastases and outside of the brain (assessed by Investigator)
    •Duration Of Response, Progression Free Survival, time to development of new brain metastases, Overall Survival
    •Safety (assessed by NCI CTCAE)
    E.5.2.1Timepoint(s) of evaluation of this end point
    June 2014
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    QUALITY OF LIFE AND PHYSICAL SYMPTOMS
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial0
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA7
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Canada
    France
    Germany
    Italy
    Netherlands
    Spain
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of study will occur when all patients have been followed up for survival for a maximum period of 24 months, have died, withdraw consent or are lost to follow up, whichever occurs first
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 106
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 26
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 61
    F.4.2.2In the whole clinical trial 132
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-07-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-08-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-07-30
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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