Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2018-001946-32
    Sponsor's Protocol Code Number:ARRAY-162-115
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-10-30
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2018-001946-32
    A.3Full title of the trial
    A Multicenter, Open-label Phase Ib Study of the Combination of Binimetinib and Encorafenib in Adolescent Patients with Unresectable or Metastatic BRAF V600-mutant Melanoma
    P/071/2018
    Multicentrická otevřená studie fáze 1b hodnotící kombinaci přípravků binimetinib a enkorafenib u dospívajících pacientů s neresekovatelným nebo metastatickým melanomem s mutací BRAF V600 / A Multicenter, Open-label Phase 1b Study of the Combination of Binimetinib and Encorafenib in Adolescent Patients with Unresectable or Metastatic BRAF V600-mutant Melanoma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of binimetinib and encorafenib in patients aged 12 to 17 with a specific type of melanoma (BRAF V600-mutant melanoma) that cannot be completely removed by surgery or that has spread to other areas in the body.
    A.4.1Sponsor's protocol code numberARRAY-162-115
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/074/2018
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorArray BioPharma Inc.
    B.1.3.4CountryUnited States
    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 supportArray Biopharma Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationArray BioPharma Inc.
    B.5.2Functional name of contact pointClinical Trials.gov call centre
    B.5.3 Address:
    B.5.3.1Street Address235 East 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY 10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1908963-6607
    B.5.6E-mailClinicalTrials.gov_Inquiries@Pfizer.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 Mektovi 15 mg film-coated tablets
    D.2.1.1.2Name of the Marketing Authorisation holderPierre Fabre Medicament
    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.3.1Product nameBinimetinib
    D.3.2Product code MEK162
    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 INNBINIMETINIB
    D.3.9.1CAS number 606143-89-9
    D.3.9.2Current sponsor codeARRY-438162
    D.3.9.4EV Substance CodeSUB179942
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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.IMP: 2
    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 Braftovi 75 mg hard capsules
    D.2.1.1.2Name of the Marketing Authorisation holderPierre Fabre Medicament
    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.3.1Product nameEncorafenib
    D.3.2Product code LGX818
    D.3.4Pharmaceutical form Capsule, hard
    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 INNEncorafenib
    D.3.9.1CAS number 1269440-17-6
    D.3.9.2Current sponsor codeLGX818
    D.3.9.3Other descriptive nameNVP-LGX818-NXA
    D.3.9.4EV Substance CodeSUB32790
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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
    Unresectable or metastatic BRAF V600-mutant melanoma
    E.1.1.1Medical condition in easily understood language
    Melanoma (a type of cancer), that cannot be completely removed by surgery or that has spread to other areas of the body
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10029104
    E.1.2Term Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Characterize the pharmacokinetics of binimetinib, its active metabolite (AR00426032), encorafenib and its metabolite (LHY746) in adolescent patients with unresectable or metastatic BRAF V600-mutant melanoma
    E.2.2Secondary objectives of the trial
    - Assess the safety and tolerability of the binimetinib/encorafenib treatment combination
    - Identify the recommended doses in expansion of binimetinib and encorafenib
    - Assess the palatability of pediatric formulations of binimetinib and encorafenib
    - Assess the efficacy of the binimetinib/encorafenib treatment combination
    - Assess the impact of the binimetinib/encorafenib treatment on bone growth and soft tissue mineralization
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male or female 12 to < 18 years of age at the time of consent/assent.
    - Histologically confirmed diagnosis of locally advanced, unresectable or metastatic cutaneous melanoma or unknown primary melanoma American Joint Committee on Cancer Stage IIIB, IIIC, or IV.
    - Presence of BRAF V600E or V600K mutation in tumor tissue as determined by a local or central laboratory.
    - Evidence of at least one evaluable lesion (measurable or non-measurable) as detected by radiological or photographic methods based on RECIST v1.1.
    - Adequate cardiac function:
    a. Left ventricular ejection fraction ≥ 50% as determined by ECHO or MUGA scan and above the institutional lower limit of normal;
    b. Triplicate average baseline QTcF value ≤ 450 ms.
    - Adequate bone marrow, organ function, and laboratory parameters:
    a. Absolute neutrophil count ≥ 1.5 × 109/L;
    b. Hemoglobin ≥ 9 g/dL with or without transfusions;
    c. Platelets ≥ 75 × 109/L without transfusions;
    d. Aspartate aminotransferase and/or alanine aminotransferase ≤ 2.5 × upper limit of normal (ULN); in patients with liver metastases ≤ 5 × ULN;
    e. Total bilirubin ≤ 1.5 × ULN. Patients with documented Gilbert syndrome or hyperbilirubinemia due to non-hepatic cause (e.g., hemolysis, hematoma) may be enrolled following discussion and agreement with the Sponsor;
    f. Creatinine ≤ 1.5 × institutional ULN for age, or calculated creatinine clearance ≥ 70 mL/min/1.73 m2 (following Schwartz formula).
    - Adequate performance status at Screening:
    a. Patients < 16 years old: Lansky Performance Scale score ≥ 80
    b. Patients 16 to 17 years old: Karnofsky Performance Scale score ≥ 80
    - Female patients of childbearing potential must agree to take appropriate precautions to avoid pregnancy from screening through 8 weeks following end of therapy and must have a negative pregnancy test at Screening and predose at Day 1.
    - Males must agree to take appropriate precautions to avoid fathering a child from Screening through 90 days following end of therapy.
    E.4Principal exclusion criteria
    - Presence of BRAFwt or indeterminate melanoma in tumor tissue as determined by local and central laboratory.
    - Known sensitivity or contraindication to any component of study treatment (binimetinib and encorafenib), or their excipients.
    - Uveal or mucosal melanoma.
    - Brain metastases that are uncontrolled or symptomatic, require steroids, are potentially life-threatening or have required radiation within 28 days prior to starting study drug.
    - History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO.
    - Prior therapy with a BRAF inhibitor and/or a MEK inhibitor
    - Impaired cardiovascular function or clinically significant cardiovascular disease, including any of the following:
    a. History of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass grafting, coronary angioplasty or stenting) < 6 months prior to screening,
    b. Symptomatic chronic heart failure, history or current evidence of clinically significant cardiac arrhythmia and/or conduction abnormality < 6 months prior to screening except atrial fibrillation and paroxysmal supraventricular tachycardia.
    - Concurrent neuromuscular disorder associated with elevated creatine kinase.
    - Impairment of gastrointestinal function.
    - Uncontrolled arterial hypertension despite medical treatment.
    - Known history of positive test for human immunodeficiency virus or known acquired immunodeficiency syndrome.
    - Known active hepatitis B and/or active hepatitis C infection.
    - Patients who have undergone major surgery or radiotherapy ≤ 2 weeks prior to starting study treatment or who have not recovered from side effects of such procedure.
    - Pregnant or lactating females.
    - History of Gilbert’s syndrome.
    - Receipt of non-topical medication known to be a strong inhibitor or strong inducer of cytochrome P450 3A4 within 3 days prior to Screening.
    E.5 End points
    E.5.1Primary end point(s)
    Plasma concentration-time profiles and PK parameter estimates for binimetinib, its active metabolite (AR00426032), encorafenib and its metabolite (LHY746)
    E.5.1.1Timepoint(s) of evaluation of this end point
    57 days
    E.5.2Secondary end point(s)
    - Incidence and severity of adverse events, including ophthalmologic events, and changes in clinical laboratory tests, vital signs, 12-lead electrocardiograms, echocardiogram/multi-gated acquisition scans and ophthalmic evaluations
    - Incidence of dose-limiting toxicities
    - Palatability score for the pediatric formulations as assessed by an age-appropriate questionnaire
    - Objective response rate as assessed by the investigator, based on Response Criteria Evaluation in Solid Tumors (RECIST) v1.1
    - Duration of response
    - Time to response
    - Progression-free survival
    - One-year survival rate
    - Change from baseline bone age and the difference in bone age and chronological age
    - Change from Baseline in bone densitometry based on dual-energy X-ray absorptiometry (DEXA) scan
    - Change from Baseline in calcium-phosphorus product (Ca × P)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Up to 2 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 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
    Palatability of paediatric formulation
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Phase IB to assess PK, safety and efficacy
    E.7.2Therapeutic exploratory (Phase II) No
    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 No
    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 trial1
    E.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Information not present in EudraCT
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    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
    Czechia
    Germany
    Italy
    New Zealand
    Switzerland
    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
    End of study will be defined as the point when all patients have had the opportunity to be followed for at least 2 years after the start of study treatment.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months48
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months48
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 18
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 18
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 state1
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 18
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Patients still receiving study drugs at the end of the study will be allowed to continue at the discretion of the Investigator in consultation with the Sponsor provided none of the treatment discontinuation criteria are met.
    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 Decision2021-12-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-11-07
    P. End of Trial
    P.End of Trial StatusCompleted
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri May 09 14:32:53 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA