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    Summary
    EudraCT Number:2018-004520-10
    Sponsor's Protocol Code Number:ACNS1021
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2019-06-25
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2018-004520-10
    A.3Full title of the trial
    2018-004520-10
    A Phase II Study of Sunitinib (NSC# 736511, IND# 74019) in Recurrent, Refractory or Progressive High Grade Glioma and Ependymoma Tumors in
    Pediatric and Young Adult Patients
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to test sunitinib in pediatric and young adults patients with brain tumors
    A.4.1Sponsor's protocol code numberACNS1021
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01462695
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/147/2018
    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 (NCI)
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer, Inc.
    B.5.2Functional name of contact pointClinical Trials.gov Call Center
    B.5.3 Address:
    B.5.3.1Street Address235 E 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post code10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number8007181021
    B.5.5Fax number3037391119
    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 Sutent
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Europe MA EEIG
    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 nameSutent
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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
    Recurrent, Refractory or Progressive High Grade Glioma and Ependymoma Tumors
    E.1.1.1Medical condition in easily understood language
    brain tumour
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To estimate the objective response rate (ORR [partial response {PR} or complete response {CR} 8 weeks]) to sunitinib in 2 strata of recurrent or progressive brain tumors in pediatric and young adult patients. The target tumors were:
    •Stratum A: Recurrent/progressive/refractory HGG (excluding diffuse intrinsic pontine glioma).
    •Stratum B: Recurrent/progressive/refractory ependymoma
    E.2.2Secondary objectives of the trial
    •To explore and report descriptively the safety and tolerability of sunitinib in pediatric and young adult patients with brain tumors who had not received prior anthracycline or radiotherapy involving the heart.
    •To describe the PK profile of pediatric and young adult patients taking sunitinib.
    •To describe the cumulative toxicities of sunitinib when administered over multiple courses to pediatric and young adult patients.
    •To estimate progression-free survival (PFS) distributions for these cohorts of patients
    •To evaluate changes in phosphorylation of PDGFR- and -, MEK/extracellular signal-regulated kinases (ERK), S6 kinase and AKT in peripheral blood mononuclear cells (PBMCs) and explore possible associations between these changes and outcome measures.
    •To evaluate plasma levels of soluble isoforms of VEGFR-1 and -2 prior to initiation of therapy and at points during therapy as an exploration of possible biomarkers of clinical response.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Age: 18 months of age and <22 years of age at the time of study enrollment.
    •Diagnosis: Patients must have been diagnosed with ependymoma or HGG (World Health Organization Grade III/IV)
    A histological diagnosis from either the initial presentation or at the time of recurrence was required.
    •Patients had to have radiographically documented measurable disease in the brain, defined as at least 1 lesion that could be accurately measured in at least 2 planes.
    •Cranial and spinal MRI
    Performance level:
    •Patients had to have a performance status corresponding to ECOG scores of 0, 1 or 2. Karnofsky performance status was used for patients >16 years of age and Lansky for patients 16 years of age.
    •Note: Neurological deficits in patients must have been relatively stable for a minimum of 1 week prior to study enrollment. Patients who were unable to walk because of paralysis, but who were up in a wheelchair, were considered ambulatory for the purpose of assessing the performance score.
    •Prior therapy: Patient must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study
    Concomitant medication restrictions:
    •Steroids: Patients who were receiving dexamethasone must have been on a stable or decreasing dose for at least 7 days prior to enrollment.
    •Cytochrome P450-3A4 (CYP)-3A4 inhibitors and/or inducers: Must not have received potent inhibitors within 7 days prior to study enrollment and potent inducers within 12 days prior to study enrollment.
    •Hematopoietic growth factors: At least 7 days must have elapsed since the completion of therapy with a growth factor
    Organ function requirements:
    •Adequate bone marrow function
    •Adequate renal function
    •Adequate liver function
    •Adequate cardiac function
    •Central nervous system (CNS) function
    •Adequate coagulation
    • Patients must have had the ability to take oral medication, either by mouth or via gastric tube

    E.4Principal exclusion criteria
    •Diagnosed with diffuse intrinsic pontine glioma.
    •Had previously received sunitinib or had received other VEGF pathway, PDGFR, or KIT targeted therapy. The one exception to this rule was that patients who received bevacizumab as part of their prior therapy could enroll in the study.
    •Had >2 prior chemotherapy and/or RT regimens. For example, 1 initial treatment course of chemotherapy and/or RT (counted as 1 treatment course) and at relapse, had1 treatment course of chemotherapy and/or RT (counted as 1 treatment course).
    •Evidence of new CNS hemorrhage of more than punctate size and/or >3 foci of punctate hemorrhage on baseline MRI obtained within 14 days prior to study enrollment.Note: Echo gradient MRI sequences per institutional guidelines were required for evaluation of CNS hemorrhage.
    •Received prior therapy with known risk for cardiovascular complications (eg, anthracycline therapy or prior RT that included the heart and/or craniospinal radiation) or had a personal history of genetic and/or congenital cardiac abnormalities.
    • Had a history of cardiac disease
    •Had a cerebrovascular accident, transient ischemic attack, pulmonary embolism or other significant thromboembolic event within 12 months prior to enrollment.
    •Had Grade 3 hemorrhage within 4 weeks prior to enrollment.
    •Had any diagnoses of peptic ulcer disease, inflammatory bowel disease, diverticulitis, abdomen fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to enrollment.
    •Had an uncontrolled infection.
    •Were receiving antiretroviral therapy for human immunodeficiency virus disease, ongoing treatment with therapeutic doses (ie, therapeutic INR levels) of coumarin-derivatives or oral anti-vitamin K agents, or investigational agents.
    •Had hypothyroidism that had not been well-controlled by medications for at least 2 weeks prior to study entry.
    •Were receiving investigational agents.
    •Had a history of allergic reactions to compounds of similar chemical or biological composition to sunitinib.
    •Had any other condition that could result in an inability to swallow capsules/sprinkles or absorb oral sunitinib administered through a gastric tube.
    •BSA <0.55 m2 or >2.18 m2.
    •Pregnancy or breastfeeding
    E.5 End points
    E.5.1Primary end point(s)
    Objective Response Rate
    E.5.1.1Timepoint(s) of evaluation of this end point
    Lasting ≥ 8 weeks
    E.5.2Secondary end point(s)
    Objective Response Rate
    E.5.2.1Timepoint(s) of evaluation of this end point
    Lasting ≥ 8 weeks
    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 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 Information not present in EudraCT
    E.8.1.2Open Yes
    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.8.2.4Number 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
    Australia
    Canada
    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
    24 June 2013 (the study was closed by COG at the time of the planned interim analysis); 31 December 2013 (Data Cut-Off Date for Final
    Analysis)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months2
    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: 30
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 10
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 10
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 10
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 15
    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
    Pediatric population

    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 45
    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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