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    Summary
    EudraCT Number:2010-024133-23
    Sponsor's Protocol Code Number:NO25530
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-05-16
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2010-024133-23
    A.3Full title of the trial
    An Open-Label, Multi-Center Phase II Study of the BRAF Inhibitor RO5185426 in Patients with Metastatic or Unresectable Papillary Thyroid Cancer (PTC) positive for the BRAF V600 Mutation and Resistant to Radioactive Iodine
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of RO5185426 in Patients With Metastatic or Unresectable Papillary Thyroid Cancer Positive for the BRAF V600 Mutation
    A.4.1Sponsor's protocol code numberNO25530
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01286753
    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 Yes
    D.2.1.1.1Trade name Zelboraf
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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
    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 or unresectable papillary thyroid cancer positive for BRAFV600 mutation and resistant to radioactive iodine therapy
    E.1.1.1Medical condition in easily understood language
    Neoplasms
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.1
    E.1.2Level LLT
    E.1.2Classification code 10033701
    E.1.2Term Papillary thyroid cancer
    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 best overall response rate (BORR) (complete + partial response) in Cohort 1 (TKI-naïve patients).
    − BORR will be based on investigator assessment, based on the findings on computed tomography (CT) or magnetic resonance imaging, using RECIST 1.1
    E.2.2Secondary objectives of the trial
    1. To evaluate clinical benefit rate (CBR) in TKI-naïve patients
    2. To further assess efficacy of vemurafenib using the following secondary variables: duration of response, progression free survival (PFS), and overall survival (OS) in TKI-naïve patients
    3. To evaluate the efficacy (BORR, CB, duration of response, PFS, and OS) in TKI-exposed patients
    4. To evaluate the tolerability and safety profile of vemurafenib using the NCI CTCAE (version 4.0) in both TK-naïve and TKI-treated patients
    5. To characterize the pharmacokinetic (PK) profile of vemurafenib in patients with thyroid cancer
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Adult patients. >/= 18 years of age

    - Metastatic or unresectable papillary thyroid cancer for which standard curative or palliative measures do not exist or are no longer effective

    - Positive for BRAF V600 mutation (Roche Cobas 4800 BRAF V600 Mutation Test)

    - Radioactive Iodine resistant disease

    - Prior therapy excluding (Cohort 1) or including (Cohort 2) tyrosine kinase inhibitor with activity against VEGFR2

    - Clinically relevant disease progression according to RECIST criteria within the prior 14 months

    - Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

    - Adequate hematological, renal and liver function
    E.4Principal exclusion criteria
    - Histological diagnosis other than papillary thyroid carcinoma (PTC), including squamous cell variants of PTC or PTC with areas of squamous metaplasia

    - Active or untreated CNS metastases

    - History of or known carcinomatous meningitis

    - Anticipated or ongoing administration of any anti-cancer therapies other than those administered in the study

    - Active squamous cell skin cancer that has not been excised or adequately healed post excision

    - Previous treatment with any agent that specifically and selectively targets the MEK or BRAF pathway

    - Prior radiotherapy to the only measurable lesion

    - Clinically relevant cardio-vascular disease or event within the prior 6 months
    E.5 End points
    E.5.1Primary end point(s)
    Best overall response rate (BORR) in tyrosine kinase inhibitor-naïve patients (Cohort 1), assessed by the investigator according to RECIST criteria
    E.5.1.1Timepoint(s) of evaluation of this end point
    18 months
    E.5.2Secondary end point(s)
    1. Clinical benefit rate (objective response rate + stable disease) in tyrosine kinase inhibitor-naïve patients
    2. Duration of response in tyrosine kinase inhibitor-naïve patients
    3. Progression-free survival in tyrosine kinase inhibitor-naïve patients
    4. Overall survival in tyrosine kinase inhibitor-naïve patients
    5. Best overall response rate in tyrosine kinase inhibitor-exposed patients (Cohort 2)
    6. Clinical benefit rate in tyrosine kinase inhibitor-exposed patients
    7. Duration of response in tyrosine kinase inhibitor-exposed patients
    8. Progression-free survival in tyrosine kinase inhibitor-exposed patients
    9. Overall survival in tyrosine kinase inhibitor-exposed patients
    10. Safety: Incidence of adverse events
    11. Pharmacokinetics (Tmax, Cmax, Cmin, AUC)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Time Frame: 18 months
    2. Time Frame: 4.5 years
    3. Time Frame: 4.5 years
    4. Time Frame: 4.5 years
    5. Time Frame: 18 months
    6. Time Frame: 18 months
    7. Time Frame: 4.5 years
    8. Time Frame: 4.5 years
    9. Time Frame:4.5 years
    10. Time Frame:4.5 years
    11. Time Frame: 4.5 years
    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 Yes
    E.6.7Pharmacodynamic Yes
    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
    Samples for BRAF V600 testing, exploratory biomarkers, Roche Clinical Repository, tolerability
    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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA8
    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
    France
    Italy
    Netherlands
    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 study will end when all patients have completed at least 6 months of follow up after discontinuation of study drug.
    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 months1
    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 months1
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 31
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 9
    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 32
    F.4.2.2In the whole clinical trial 40
    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 Decision2011-05-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-10-31
    P. End of Trial
    P.End of Trial StatusCompleted
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