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    Summary
    EudraCT Number:2014-005190-36
    Sponsor's Protocol Code Number:20050252
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2015-01-22
    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 number2014-005190-36
    A.3Full title of the trial
    A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of Panitumumab in Children with Solid Tumors
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the safety of panitumumab and children with solid tumours
    A.4.1Sponsor's protocol code number20050252
    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 SponsorAmgen 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 supportAmgen Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmgen (EUROPE) GmbH
    B.5.2Functional name of contact pointIHQ Medical Information – Clinical
    B.5.3 Address:
    B.5.3.1Street AddressDammstrasse 23, PO Box 1557
    B.5.3.2Town/ cityZug
    B.5.3.3Post codeCH 6300
    B.5.3.4CountrySwitzerland
    B.5.6E-mailMedinfoInternational@amgen.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 Vectibix 20 mg/ml concentrate for solution for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderAmgen Europe B.V.
    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 nameVectibix
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPANITUMUMAB
    D.3.9.1CAS number 339177-26-3
    D.3.9.2Current sponsor codeAMG 954
    D.3.9.4EV Substance CodeSUB25390
    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 No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 Tumours
    E.1.1.1Medical condition in easily understood language
    Solid Tumours
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10065147
    E.1.2Term Malignant solid tumor
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10065252
    E.1.2Term Solid tumor
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10049280
    E.1.2Term Solid tumour
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    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 evaluate the safety and pharmacokinetics (PK) of up to 3 different dose schedules of panitumumab in pediatric subjects with solid tumors.
    E.2.2Secondary objectives of the trial
    To evaluate the incidence of human anti-panitumumab antibody
    (HAPA) formation and to preliminarily determine if there is evidence of anti-tumor activity of panitumumab in this patient population.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • All parents or legal guardians must provide voluntary, signed-written informed consent before any study-specific procedure is conducted. In addition to providing written informed consent, the assent of the child (if applicable) must also be obtained in accordance with the institutional review board (IRB)/independent ethics committee before
    any study-specific procedure is conducted.
    • 1 to < 18 years of age
    • Histologically or cytologically confirmed solid tumor that has recurred after standard therapy, or for which there is no standard therapy. Subjects with brainstem glioma DO NOT need histologic proof of the diagnosis.
    • Central nervous system (CNS) tumors (primary or metastatic) are allowed.
    Note:
    Subjects who have received prior radiotherapy for CNS metastases must have a minimum of 4 weeks elapsed since last dose of radiotherapy and be considered medically stable and must be on a stable dose of corticosteroids for a minimum of 2 weeks prior to participation in the study.
    • Paraffin-embedded tumor tissue from primary tumor or metastasis for determination of epidermal growth factor receptor (EGFr) expression and biomarker testing (not required for brainstem gliomas, if not available)
    • Presence of measurable or non-measurable disease
    • Life expectancy of ≥ 12 weeks
    • Performance status: Karnofsky ≥ 60% for 12 to < 18 years of age (Appendix M); Lansky play scale ≥ 60% for children 1 to < 12 years of age (Appendix N)
    • Adequate hematologic function, as follows:
    - Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
    - Platelet count ≥ 75 x 109/L
    - Hemoglobin ≥ 9 g/dL
    • Adequate renal function as follows:
    - Serum creatinine ≤ 1.5 x upper limit of normal (ULN) for age
    • Adequate hepatic function, as follows:
    − Aspartate aminotransferase (AST) ≤ 3 x ULN (≤ 5 X ULN if liver metastases)
    − Alanine aminotransferase (ALT) ≤ 3 x ULN (≤ 5 X ULN if liver metastases)
    − Total bilirubin ≤ 1.5 X ULN
    • Magnesium ≥ lower limit of normal
    • Adequate pulmonary function, as follows:
    − Resting O2 saturation on room air ≥ 92% by pulse oximetry
    • All previous therapy-related toxicities must have resolved or returned to baseline
    E.4Principal exclusion criteria
    • Diagnosis of leukemia, non-Hodgkin’s lymphoma, Hodgkin’s disease, or other hematologic malignancy
    • Any prior allogeneic transplant
    • Prior autologous bone marrow or peripheral stem cell transplant less than 3 months prior to enrollment
    • Substantial radiotherapy to the bone marrow within 6 weeks prior to enrollment (or within 6 months prior to enrollment if prior radiotherapy to the craniospinal axis or to at least 59% of the pelvis was received; within 2 weeks prior to enrollment if local palliative radiotherapy was received)
    • Prior use of any monoclonal antibodies directly targeting the EGFr. Subjects who have received prior tyrosine kinase inhibitors such as gefitinib (Iressa) or erlotinib (Tarceva) are eligible.
    • Immunotherapy, radiotherapy, or chemotherapy ≤ 2 weeks prior to enrollment (≤ 6 weeks for nitrosoureas, mitomycin-C, and liposomal doxorubicin, and ≤ 6 weeks from prior antibody therapy)
    • Requirement to receive concurrent chemotherapy, immunotherapy, radiotherapy (except for pain control), or any other investigational drug while on this study
    • Prior seizures < 3 months prior to enrollment. Subjects with a history of seizure disorders ≥ 3 months prior to enrollment must be seizure free and on stable anticonvulsant medication(s) for ≥ 3 months prior to enrollment.
    • Presence of a serious uncontrolled medical disorder
    • Dementia, altered mental status, or any other medical condition or disorder that would prohibit the understanding or rendering of assent (if applicable), or ability to comply with study procedures
    • Major surgery ≤ 28 days prior to enrollment
    • Known or suspected history of interstitial lung disease (eg, pneumonitis or pulmonary fibrosis)
    • Active inflammatory bowel disease or other bowel disease causing chronic diarrhea (defined as ≥ CTC grade 2 [CTCAE version 3.0])
    • Known positive test for human immunodeficiency virus infection, hepatitis C virus, acute or chronic hepatitis B infection, or any co-morbid disease that would increase risk of toxicity
    • Females of childbearing potential not using adequate contraception precautions for the duration of the study treatment and for 2 months after the last administration of investigational product
    • Pregnant or breast-feeding, or planning to become pregnant during study treatment and within 2 months after the last administration of investigational product
    • Received investigational therapy or procedure ≤ 30 days prior to enrollment
    E.5 End points
    E.5.1Primary end point(s)
    • Safety and Tolerability: subject and cohort incidence of grade 3 and 4 adverse events (AEs) including DLTs, serious adverse events (SAEs), and events requiring the discontinuation of study drug
    • Safety: subject incidence of clinically significant laboratory changes, clinically significant changes in vital signs, and all AEs
    • PK parameters: AUC, Cmin and Cmax, t1/2, CL, and V
    The results of this study will be used to define a safe dose schedule to be tested in a Phase 2 study in this population.
    E.5.1.1Timepoint(s) of evaluation of this end point
    There are no set timepoints for the evaluation of the endpoints, as the study is cohort driven.
    E.5.2Secondary end point(s)
    • Immunogenicity: incidence of human anti-panitumumab antibody formation
    • Efficacy: tumor response. These endpoints will pertain only to subjects with measurable disease at baseline. Tumor response will be assessed per the investigator (ie, no central review) using a modification of the RECIST criteria version 1.0 (Appendix L).
    E.5.2.1Timepoint(s) of evaluation of this end point
    There are no set timepoints for the evaluation of the endpoints, as the study is cohort driven.
    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 No
    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) 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
    Evaluation of pharmacokinetics in children with solid tumors
    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 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
    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 is defined as completion of the 30 days ± 3 days safety visit after the last dose of panitumumab after the last subject is enrolled.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years3
    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: 24
    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: 6
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 6
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 12
    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 No
    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
    Paediatric subjectes whom adults carers will provide informed signed consent
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Paediatrics
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 36
    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)
    There is no long term follow-up planned for this study.
    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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