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    Summary
    EudraCT Number:2021-005604-35
    Sponsor's Protocol Code Number:APEC1621B
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2022-01-18
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2021-005604-35
    A.3Full title of the trial
    NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) - Phase 2 Subprotocol of JNJ-42756493 (Erdafitinib) in Patients With Tumors Harboring FGFR1/2/3/4 Alterations
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Erdafitinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With FGFR Mutations (A Pediatric MATCH Treatment Trial)
    A.4.1Sponsor's protocol code numberAPEC1621B
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03210714
    A.5.4Other Identifiers
    Name:Janssen protocol ID Number:42756493STM2001
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/223/2021
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNational Cancer Institute (NCI)
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNational Cancer Institute funding support
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationChildren's Oncology Group
    B.5.2Functional name of contact pointS. Dir. Industry sponsored trials
    B.5.3 Address:
    B.5.3.1Street Address800 Royal Oaks Dr, Suite 210
    B.5.3.2Town/ cityMonrovia
    B.5.3.3Post codeCA 91016
    B.5.3.4CountryUnited States
    B.5.4Telephone number(626) 241-1512
    B.5.5Fax number(626) 445-4334
    B.5.6E-mailntowcimak@childrensoncologygroup.org
    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.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameErdafitinib
    D.3.2Product code JNJ-42756493
    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 INNErdafitinib
    D.3.9.1CAS number 1346242-81-6
    D.3.9.2Current sponsor codeJNJ-42756493
    D.3.9.3Other descriptive nameERDAFITINIB
    D.3.9.4EV Substance CodeSUB167731
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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
    Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With FGFR Mutations
    E.1.1.1Medical condition in easily understood language
    Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With FGFR Mutations
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10065143
    E.1.2Term Malignant solid tumour
    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 determine the objective response rate (ORR; complete response + partial response) in pediatric patients treated with JNJ-42756493 (erdafitinib) with advanced solid tumors (including central nervous system [CNS] tumors), non-Hodgkin lymphomas or histiocytic disorders that harbor genetic alterations in the FGFR1/2/3/4 pathway.
    E.2.2Secondary objectives of the trial
    I. To estimate the progression free survival in pediatric patients treated
    with JNJ-42756493 (erdafitinib) with advanced solid tumors (including
    CNS tumors), non-Hodgkin lymphomas or histiocytic disorders that
    harbor genetic alterations in the FGFR1/2/3/4.

    II. To obtain information about the tolerability of JNJ-42756493
    (erdafitinib) in children with relapsed or refractory cancer.

    III. To provide preliminary estimates of the pharmacokinetics of JNJ-
    42756493 (erdafitinib) in children with relapsed or refractory cancer.

    EXPLORATORY OBJECTIVES:

    I. To explore approaches to profiling changes in tumor genomics over
    time through evaluation of circulating tumor deoxyribonucleic acid
    (DNA).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patient must have enrolled onto APEC1621SC and must have been given a treatment assignment to molecular analysis for therapy choice (MATCH) to APEC1621B based on the presence of an actionable mutation.

    Patients must have a body surface area >= 0.53 m^2 at enrollment

    Patients must have radiographically measurable disease at the time of study enrollment; patients with neuroblastoma who do not have measurable disease but have metaiodobenzylguanidine (MIBG) positive (+) evaluable disease are eligible; measurable disease in patients with CNS involvement is defined as tumor that is measurable in two
    perpendicular diameters on magnetic resonance imaging (MRI) and visible on more than one slice
    Note: The following do not qualify as measurable disease:
    - Malignant fluid collections (e.g., ascites, pleural effusions)
    - Bone marrow infiltration except that detected by MIBG scan for neuroblastoma
    - Lesions only detected by nuclear medicine studies (e.g., bone, gallium or positron emission tomography [PET] scans) except as noted for neuroblastoma
    - Elevated tumor markers in plasma or cerebrospinal fluid (CSF)
    - Previously radiated lesions that have not demonstrated clear progression post radiation
    - Leptomeningeal lesions that do not meet the measurement requirements for Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

    Karnofsky >= 50% for patients > 16 years of age and Lansky >= 50 for patients =< 16 years of age; Note: neurologic deficits in patients with CNS tumors must have been stable for at least 7 days prior to study enrollment; patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score
    E.4Principal exclusion criteria
    Pregnant or breast-feeding women will not be entered on this study due to risks of
    fetal and teratogenic adverse events as seen in animal studies. Pregnancy tests must
    be obtained in girls who are post-menarchal. Males or females of reproductive
    potential may not participate unless they have agreed to use an effective
    contraceptive method, while receiving study treatment and for 3 months after the
    last dose of JNJ-42756493 (erdafitinib). Male subjects (with a partner of childbearing
    potential) must use a condom with spermicide when sexually active and must
    not donate sperm from the first dose of study drug until 5 months after the last dose
    of study drug.

    Concomitant Medications
    - Corticosteroids: Patients receiving corticosteroids who have not been on
    a stable or decreasing dose of corticosteroid for at least 7 days prior to
    enrollment are not eligible. If used to modify immune adverse events
    related to prior therapy, ≥ 14 days must have elapsed since last dose of
    corticosteroid (See Section 4.1.6.1.d).

    - Investigational Drugs: Patients who are currently receiving another
    investigational drug are not eligible.

    - Anti-cancer Agents: Patients who are currently receiving other anti-cancer
    agents are not eligible.
    - Anti-GVHD agents post-transplant: Patients who are receiving cyclosporine, tacrolimus or other agents to
    prevent graft-versus-host disease post bone marrow transplant are not
    eligible for this trial.

    - CYP3A4 Agents: Patients who are currently receiving drugs that are
    strong inducers or inhibitors of CYP3A4 are not eligible.

    - CYP2C9 Agents: Patients who are currently receiving drugs that are
    moderate to strong inducers or inhibitor of CYP2C9 are not eligible.

    - P-glycoprotein: Patients who are currently receiving drugs that are potent
    inhibitors of p-glycoprotein are not eligible.

    Infection: Patients who have an uncontrolled infection are not eligible.

    Patients who have received a prior solid organ transplantation are not eligible.

    Patients who in the opinion of the investigator may not be able to comply with the
    safety monitoring requirements of the study are not eligible.

    A history of cardiovascular diseases: Unstable angina, myocardial infarction, or
    known congestive heart failure Class IIIV within the preceding 12 months;
    cerebrovascular accident or transient ischemic attack within the preceding 3
    months, pulmonary embolism within the preceding 2 months.

    A history of any of the following: sustained ventricular tachycardia, ventricular
    fibrillation, Torsades de Pointes, cardiac arrest, Mobitz II second degree heart
    block or third degree heart block; known presence of dilated, hypertrophic, or
    restrictive cardiomyopathy.

    Uncontrolled intercurrent illness including, but not limited to, ongoing or active
    infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
    arrhythmia, or psychiatric illness/social situations that would limit compliance
    with study requirements.

    Patients with known significant ophthalmologic conditions (uncontrolled
    glaucoma, history of retinal vein occlusion or retinal detachment, excluding
    patients with longstanding findings secondary to existing conditions) are not
    eligible
    E.5 End points
    E.5.1Primary end point(s)
    Pharmacokinetics (PK) will be performed to determine the PK of JNJ-42756493 (erdafitinib) in children.

    Plasma Protein Binding(PPB), binding of erdafitinib to plasma proteins will be determined.

    The alpha-1 acid glycoprotein concentration
    E.5.1.1Timepoint(s) of evaluation of this end point
    Blood samples will be obtained for PK & PPB on the following timepoints :
    note, the PPB samples will also be used to determine the alpha-1 acid glycoprotein concentration
    - PK & PPB Blood Sample No. 1, Cycle 2, Day 1, Pre-dose
    - PK Blood Sample No. 2, Cycle 2, Day 1, 1 hour post-dose
    - PK & PPB Blood Sample No. 3, Cycle 2, Day 1, 2 hour post-dose
    - PK Blood Sample No. 4, Cycle 2, Day 1, 4 hour post-dose
    - PK Blood Sample No. 5, Cycle 2, Day 1, 6-8 hour post-dose
    - PK Blood Sample No. 6, Cycle 2, Day 2, 24 hour post-dose
    E.5.2Secondary end point(s)
    Circulating Tumor DNA Study(optional)
    E.5.2.1Timepoint(s) of evaluation of this end point
    (1) Cycle 5 Day 1
    (2) At disease progression or end of protocol therapy (for patients receiving ≥ 5 cycles of therapy only)
    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 No
    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 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 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    Puerto Rico
    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
    Patients will continue to be followed on the APEC1621SC screening protocol. Follow-up data submission will occur until one of the APEC1621SC Off Study Criteria is met, withdrawal of consent or the patient dies or is lost to follow-up.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years7
    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 Yes
    F.1.1Number of subjects for this age range: 49
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 14
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 22
    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
    All patients and/or their parents or legally authorized representatives must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 49
    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
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: United States
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    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
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