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    The EU Clinical Trials Register currently displays   43977   clinical trials with a EudraCT protocol, of which   7312   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).

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    Summary
    EudraCT Number:2016-003498-16
    Sponsor's Protocol Code Number:20290
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2018-01-23
    Trial 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 number2016-003498-16
    A.3Full title of the trial
    A Phase 1/2 Study of the Oral TRK Inhibitor Larotrectinib in Pediatric Patients with Advanced Solid or Primary Central Nervous System Tumors
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to test the safety and efficacy of the drug larotrectinib for the treatment of tumors with NTRK-fusion in children.
    A.3.2Name or abbreviated title of the trial where available
    SCOUT
    A.4.1Sponsor's protocol code number20290
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02637687
    A.5.4Other Identifiers
    Name:Bayer Compound Number / Study NumberNumber:BAY 2757556 / 20290
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/179/2017
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBayer Consumer Care AG
    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 supportBayer Consumer Care AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBayer AG
    B.5.2Functional name of contact pointBayer Clinical Trials Contact
    B.5.3 Address:
    B.5.3.1Street AddressS102, Level 2, Room 156
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code13342
    B.5.3.4CountryGermany
    B.5.6E-mailclinical-trials-contact@bayer.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.3.1Product namelarotrectinib
    D.3.2Product code BAY 2757556
    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 INNlarotrectinib
    D.3.9.3Other descriptive nameBAY 2757556
    D.3.9.4EV Substance CodeSUB179762
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 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.3.1Product namelarotrectinib
    D.3.2Product code BAY 2757556
    D.3.4Pharmaceutical form Oral solution
    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 INNlarotrectinib
    D.3.9.3Other descriptive nameBAY 2757556
    D.3.9.4EV Substance CodeSUB179762
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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: 3
    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.3.1Product namelarotrectinib
    D.3.2Product code BAY 2757556
    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 INNlarotrectinib
    D.3.9.3Other descriptive nameBAY 2757556
    D.3.9.4EV Substance CodeSUB179762
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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: 4
    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.3.1Product namelarotrectinib
    D.3.2Product code BAY 2757556
    D.3.4Pharmaceutical form Oral solution
    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 INNlarotrectinib
    D.3.9.3Other descriptive nameBAY 2757556
    D.3.9.4EV Substance CodeSUB179762
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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
    Solid tumors harboring NTRK fusion
    E.1.1.1Medical condition in easily understood language
    Solid cancers harboring an NTRK gene fusion, rare cancers caused by specific changes in the genes
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10007959
    E.1.2Term Central nervous system neoplasm NOS
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10007958
    E.1.2Term Central nervous system neoplasm
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level HLT
    E.1.2Classification code 10007960
    E.1.2Term Central nervous system neoplasms malignant NEC
    E.1.2System Organ Class 100000004852
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10065147
    E.1.2Term Malignant solid tumor
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level PT
    E.1.2Classification code 10081769
    E.1.2Term NTRK gene fusion overexpression
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Phase 1: The primary objective of the study is to determine the safety of
    oral larotrectinib, including DLT, in pediatric patients with advanced
    solid or primary CNS tumors.
    Phase 2: To determine the overall response rate (ORR) as determined by
    an independent radiology review committee and measured by the
    proportion of patients with best overall confirmed response of complete
    response (CR) or partial response (PR) according to the appropriate
    tumor response criteria following treatment with larotrectinib in
    pediatric patients with an advanced cancer harboring a fusion involving
    NTRK1, NTRK2, or NTRK3 (collectively referred to as NTRK fusions)
    fusions.
    E.2.2Secondary objectives of the trial
    Phase 1: - To characterize the PK properties of larotrectinib, describe
    the antitumor activity of larotrectinib and describe pain and health
    related quality of life (HRQoL) in pediatric patients with advanced solid
    or primary CNS tumors.
    - To identify the MTD and/or the recommended dose of larotrectinib for further clinical investigation in this patient population.
    Phase 2: - To determine the ORR.
    - To evaluate the duration of response (DOR), duration of progressionfree
    survival (PFS) and duration of OS.
    - To estimate the proportion of patients that has any tumor regression as
    a best response.
    - To assess the safety profile and tolerability of larotrectinib.
    - To evaluate the clinical benefit rate (CBR) and the concordance of prior
    molecular profiling.
    - To characterize post-operative staging and surgical margin status.
    - To describe the putative pretreatment surgical plan and capture the
    post treatment actual approach with an emphasis on the functional and
    cosmetic outcome.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Phase 1 (Closed):
    -- Dose escalation: Birth through 21 years of age at C1D1 with a locally
    advanced or metastatic solid tumor or primary CNS tumor that has
    relapsed, progressed or was nonresponsive to available therapies and
    for which no standard or available systemic curative therapy exists; OR
    Infants from birth and older with a diagnosis of malignancy and with a
    documented NTRK fusion that has progressed or was nonresponsive to
    available therapies, and for which no standard or available curative
    therapy exists; OR Patients with locally advanced infantile fibrosarcoma
    who would require, in the opinion of the investigator, disfiguring surgery
    or limb amputation to achieve a complete surgical resection. Phase I
    dose escalation cohorts are closed to enrollment.
    -- Dose expansion: In addition to the above stated inclusion criteria,
    patients must have a malignancy with a documented NTRK gene fusion
    with the exception of patients with infantile fibrosarcoma, congenital
    mesoblastic nephroma or secretory breast cancer. Patients with infantile
    fibrosarcoma, congenital mesoblastic nephroma or secretory breast
    cancer may enroll into this cohort with documentation of an ETV6
    rearrangement by FISH or RT-PCR or a documented NTRK fusion by next
    generation sequencing.
    - Phase 2:
    -- Infants from birth and older at C1D1 with a locally advanced or
    metastatic infantile fibrosarcoma, patients with locally advanced
    infantile fibrosarcoma who would require, in the opinion of the
    investigator, disfiguring surgery or limb amputation to achieve a
    complete surgical resection; OR Birth through 21 years of age at C1D1
    with a locally advanced or metastatic solid tumor or primary CNS tumor
    that has relapsed, progressed or was nonresponsive to available
    therapies and for which no standard or available systemic curative
    therapy exists with a documented NTRK gene fusion (or in the case of
    infantile fibrosarcoma, congenital mesoblastic nephroma or secretory
    breast cancer with documented ETV6 rearrangement (or NTRK3
    rearrangement after discussion with the sponsor) by FISH or RT-PCR or
    a documented NTRK fusion by next generation sequencing) (identified
    through molecular assays as routinely performed at CLIA or other
    similarly certified laboratories). Patients with NTRK-fusion positive
    benign tumors are also eligible; OR Potential patients older than 21
    years of age with a tumor diagnosis with histology typical of a pediatric
    patient and an NTRK fusion may be considered for enrollment following
    discussion between the local site Investigator and the Sponsor.
    - Patients with primary CNS tumors or cerebral metastasis
    - Karnofsky (those 16 years and older) or Lansky (those younger than 16 years) performance score of at least 50.
    - Adequate hematologic function
    - Adequate hepatic and renal function
    E.4Principal exclusion criteria
    Patients meeting any of the following criteria are to be excluded from study participation:
    1. Major surgery within 14 days (2 weeks) prior to C1D1.
    2. Clinically significant active cardiovascular disease or history of myocardial infarction within 6 months prior to C1D1; ongoing cardiomyopathy; or current prolonged QTc interval > 480 milliseconds.
    3. Active uncontrolled systemic bacterial, viral, or fungal infection.
    4. Malabsorption syndrome or other condition affecting oral absorption.
    5. Current treatment with a strong CYP3A4 inhibitor or inducer other than those allowed per Section 6.3.2 of the study protocol.
    6. Pregnancy or lactation.
    7. Phase 2 only: Prior progression while receiving approved or investigational tyrosine kinase inhibitors targeting TRK, including entrectinib, crizotinib and lestaurtanib. Patients who received a TRK inhibitor for less than 28 days of treatment and discontinued because of intolerance remain eligible.
    E.5 End points
    E.5.1Primary end point(s)
    Phase 1:
    1. Number of participants in an assigned dose cohort with treatment
    emergent adverse events (TEAEs) by grade assessed by National Cancer
    Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)
    v 4.03 who experience a Dose-limiting toxicity (DLT).
    2. Number of participants with TEAEs
    3. Severity of TEAEs
    Phase 2:
    4. Overall response rate (ORR) by independent radiology review
    committee (IRRC)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Phase 1:
    1. From Day 1 to Day 28 of Cycle 1 (1 Cycle=28 days)
    2. From first dose of larotrectinib up to 93 months
    3. From first dose of larotrectinib up to 93 months
    Phase 2:
    4. From first dose of Larotrectinib to disease progression or subsequent
    therapy or surgical intervention or death, up to 76 months
    E.5.2Secondary end point(s)
    Phase 1:
    1. Maximum concentration of larotrectinib in plasma (Cmax)
    2. Area under the concentration versus time curve from time 0 to
    t(AUC0–t) of larotrectinib in plasma
    3. Oral clearance (CL/F)
    4. Cerebral spinal fluid/plasma ratio of Larotrectinib
    5. Maximum tolerated dose (MTD)
    6. Recommended dose for Phase 2
    7. Overall Response Rate (ORR)
    8. Mean change from baseline in Pain scores as assessed by the Wong-
    Baker Faces scale
    9. Mean change in Health-related quality of life scores by PedsQL-Core
    Phase 2:
    10. Best overall response (BOR)
    11. Duration of response (DOR)
    12. Progression-free survival (PFS)
    13. Overall survival (OS)
    14. Number of participants with Treatment emergent adverse events
    (TEAEs)
    15. Severity of adverse events as assessed by NCI-CTCAE grading V 4.03
    16. Clinical Benefit Rate (CBR)
    17. Concordance coefficient
    18. Post-operative tumor staging
    19. Post-operative surgical margin assessment
    20. Pre-treatment surgical plan to preserve function and cosmetic
    outcome
    21. Post-treatment plans to conserve function and cosmetic outcome
    E.5.2.1Timepoint(s) of evaluation of this end point
    Phase 1:
    1-3. Cohort 1 and 2: Cycle 1 Day 1 (C1D1) at 1 and 4 hours post-dose
    and C2D1 at pre-dose, and at 1 and 4 hours post-dose; Cohort 3 and
    Dose Expansion Cohort: C1D1 at 1 and 4 hours post-dose and C4D1 at
    pre-dose, 1 and 4 hours post-dose
    4. C1D1 in conjunction with the post-dose 1-hour PK sample
    5. Up to 16 months
    6. Up to 16 months
    7. Up to 93 months
    8. Up to 93 months
    9. Up to 93 months
    Phase 2:
    10. Up to 76 months
    11. Up to 76 months
    12. Up to 76 months
    13. Up to 112 months
    14. Up to 112 months
    15. Up to 112 months
    16. Up to 112 months
    17. Up to 76 months
    18. Up to 112 months
    19. Up to 112 months
    20. Up to 112 months
    21. Up to 112 months
    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 Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    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
    Dose escalation
    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 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.8.3 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 EEA14
    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
    Switzerland
    Ukraine
    Ireland
    Australia
    Canada
    China
    Czechia
    Denmark
    France
    Germany
    Israel
    Italy
    Japan
    Korea, Republic of
    Netherlands
    Poland
    Russian Federation
    Spain
    Sweden
    Turkey
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee No
    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
    Last Patient Last Visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years10
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days22
    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: 161
    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) Yes
    F.1.1.3.1Number of subjects for this age range: 10
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 50
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 50
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 37
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 13
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Patients newborn to their legal majority age, with a documented NTRK fusion
    Infants from birth with a diagnosis malignancy and for patients with a locally advanced or metastatic infantile fibrosarcoma
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 174
    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)
    None
    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 Decision2018-01-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-09-25
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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