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    Summary
    EudraCT Number:2011-002008-33
    Sponsor's Protocol Code Number:A6181196
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-12-16
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2011-002008-33
    A.3Full title of the trial
    A PHASE I/II STUDY OF SUNITINIB IN YOUNG PATIENTS WITH ADVANCED GASTROINTESTINAL STROMAL TUMOR
    A SUNITINIB I/II. FÁZISÚ VIZSGÁLATA ELŐREHALADOTT GASZTROINTESZTINÁLIS STRÓMA TUMOROS FIATAL BETEGEK KÖRÉBEN
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of Sunitinib in Young Patients with Advanced Gastrointestinal Stromal Tumor
    A sunitinib vizsgálata előrehaladott gasztrointesztinális stróma tumoros fiatal betegek körében
    A.4.1Sponsor's protocol code numberA6181196
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/045/2012
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPfizer Inc., 235 East 42nd Street, New York, NY 10017
    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 supportPfizer Inc., 235 East 42nd Street, New York, NY 10017
    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 pointClincal Trials.gov Call Center
    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 number001800718 1021
    B.5.5Fax number001303739 1119
    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 Limited
    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.3.4Pharmaceutical form Capsule
    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 INNSunitinib malate
    D.3.9.1CAS number 341031-54-7
    D.3.9.2Current sponsor codeSU011248
    D.3.9.3Other descriptive nameSU011248 L-Malate; SU010398; PHA-290940AD
    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 Yes
    D.2.1.1.1Trade name Sutent
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Limited
    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.3.4Pharmaceutical form Capsule
    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 INNSunitinib malate
    D.3.9.1CAS number 341031-54-7
    D.3.9.2Current sponsor codeSU011248
    D.3.9.3Other descriptive nameSU011248 L-Malate; SU010398; PHA-290940AD
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12.5
    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 nameSutent
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation Yes
    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 INNSunitinib malate
    D.3.9.1CAS number 341031-54-7
    D.3.9.2Current sponsor codeSU011248
    D.3.9.3Other descriptive nameSU011248 L-Malate; SU010398; PHA-290940AD
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6.25
    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
    Pediatric Gastro Intestinal Stromal Tumor (GIST)
    E.1.1.1Medical condition in easily understood language
    GIST in young patients
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10062427
    E.1.2Term Gastrointestinal stromal tumor
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To characterize the plasma PK profile of sunitinib and its active metabolite SU012662 in children and young adults with advanced GIST.
    E.2.2Secondary objectives of the trial
    • To investigate whether doses greater than the established pediatric MTD are tolerated in pediatric patients with GIST;
    • To investigate the safety and tolerability of sunitinib in children and young adults with GIST;
    • To investigate the anti tumor activity of sunitinib in children and young adults with GIST;
    • To explore PK pharmacodynamic relationships with respect to safety and efficacy in children and young adults with GIST.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients must meet all of the following inclusion criteria to be eligible to commence study drug treatment into the study:
    1. Histological diagnosis of GIST (refer to Section 6.1 of the protocol);
    2. Tumor tissue must be available to assess KIT, PDGFRA, and BRAF genotypes (for any of these genes where genotyping was not previously performed) and to assess succinate dehydrogenase (SDH) protein expression by immunohistochemistry. For exceptions see Section 6.1 of the protocol;
    3. Patients must have demonstrated disease progression or intolerance to imatinib mesylate; have GIST with non-mutant KIT (tumor genotyping may be performed prior to or during screening; patients with an indeterminate KIT genotype are eligible if genotyping performed during screening); or cannot obtain imatinib in their country.
    4. Age 6 to <21 years;
    5. Advanced, unresectable GIST for which there are no available options for treatment with curative intent as assessed by the investigator;
    6. Measurable (per Response Evaluation Criteria in Solid Tumors; RECIST version 1.1; or evaluable disease (Refer to Appendix 4 of the protocol);
    7. Resolution of all acute toxic effects of prior cancer treatment, radiotherapy or surgical procedure to NCI CTCAE v4.0 grade ≤1;
    8. ECOG Performance Status 0 2 (for patients ≥11 years of age) or Lansky ≥50% (for patients <11 years);
    9. Adequate organ function determined within 14 days prior to enrollment, defined by:
    • Peripheral absolute neutrophil count (ANC) ≥1500/µL;
    • Platelet count ≥100,000/µL;
    • Hemoglobin ≥10 g/dL;
    • Total bilirubin ≤1.5 x upper limit of normal (ULN) for age;
    • ALT (SGPT) or AST (SGOT) ≤ 3 x ULN for age;
    • Serum albumin ≥2.0 g/dL;
    • Serum amylase and lipase <1.5 x ULN;
    • Serum creatinine based on age/gender
    • Blood Pressure (BP) < the 95th percentile for age, height and gender (refer to Appendix 3 of the protocol for pediatric ranges);
    • Cardiac shortening fraction or ejection fraction greater than the lower limit of normal (LLN).
    10. Evidence of a personally signed and dated informed consent (and where applicable, assent) document indicating that the patient (or a legal representative) has been informed of all pertinent aspects of the study;
    11. Patients (including legal guardian for minors where applicable) who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures, including anticipated ability to swallow capsules;
    12. Male and female patients of childbearing potential who are sexually active must agree to use a highly effective method of contraception throughout the study and for 30 days after the last sunitinib treatment. A patient is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active (refer to section 4.3 of the protocol).
    E.4Principal exclusion criteria
    Patients presenting with any of the following will not be included in the study:
    1. Current treatment with another investigational agent and/or systemic anti-cancer therapy within 4 weeks before starting sunitinib treatment;
    2. Prior sunitinib treatment;
    3. Prior therapy with known risk for cardiovascular complications, eg, high intensity anthracycline therapy (ie, total equivalent cumulative dose > 100 mg/m2 of doxorubicin) or prior radiation therapy that included the heart (cardiac silhouette) and/or craniospinal radiation;
    4. Concomitant treatment with any drug having proarrhythmic potential (terfenadine, quinidine, procainamide, disopyramide, sotalol, probucol, bepridil, haloperidol, risperidone, indapamide and flecainide);
    5. Prior diagnosis of cardiac disease, including, but not limited to:
    • Ongoing cardiac dysrhythmias of NCI CTCAE v4.0 ≥ grade 2, atrial fibrillation of any grade;
    • QTc interval >450 msec for males or >470 msec for females;
    • Hypertension that cannot be controlled by medications;
    • Any of the following within the 12 months prior to starting study treatment: congestive heart failure, cerebrovascular accident including transient ischemic attack or pulmonary embolism.
    6. Grade ≥3 hemorrhage within 4 weeks prior to study entry;
    7. Current treatment with therapeutic doses of coumarin derivative anticoagulants such as warfarin or anti vitamin K agents;
    8. Concurrent administration of strong cytochrome P450 3A (CYP3A4) inhibitor(s) and/or inducer(s) within 7 and 12 days prior to first dose of study drug, respectively (see Section 5.5.2 of the protocol);
    9. Prior radiation to >25% of the bone marrow.
    10. Patients with history of allergic reaction attributed to any component of sunitinib capsules;
    11. Pregnant females; breastfeeding females; males and females of childbearing potential not using highly effective contraception or not agreeing to continue highly effective contraception for 30 days after last dose of investigational product; in the UK, males and females of childbearing potential not using two (2) methods of highly effective
    contraception or not agreeing to continue two (2) methods of highly effective contraception for 30 days after last dose of investigational product;
    12. Active infection with HIV, or receiving antiretroviral therapy for HIV disease;
    13. Patients who are investigational site staff members or relatives of those site staff members or patients who are Pfizer employees directly involved in the conduct of the trial;
    14. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
    E.5 End points
    E.5.1Primary end point(s)
    Pharmacokinetic parameters of sunitinib and its main active metabolite (SU012662) including total plasma exposure (AUC24) and oral clearance (CL/F).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Descriptive statistics for observed and dose-corrected (where appropriate) PK data will be reported for all patients with at least one PK observation by presenting the population size, arithmetic mean, standard deviation, percent coefficient of variation (CV%), median, minimum, maximum values at the end of the study.
    E.5.2Secondary end point(s)
    • Type, incidence, severity (graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events [CTCAE], Version 4.0 [v4.0]), timing, seriousness, and relatedness of adverse events and laboratory abnormalities;
    • Objective response rate, duration of response, PFS and OS at 2 years after study enrollment;
    • Pharmacokinetic pharmacodynamic relationships with respect to safety and efficacy in pediatric GIST
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the end of the study.
    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) 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
    PK profile of sunitinib and its active metabolite SU012662 in children and young adults with GIST
    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 Information not present in EudraCT
    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.8.3 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 EEA29
    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
    Argentina
    Austria
    Belgium
    Brazil
    Canada
    Chile
    Czech Republic
    Egypt
    France
    Germany
    Hungary
    India
    Italy
    Jordan
    Mexico
    Netherlands
    Norway
    Poland
    Singapore
    Slovakia
    Spain
    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
    End of Trial in all participating countries is defined as collection of the final data point in the study. Because this clinical trial includes a survival endpoint, the last data point is anticipated to be the last survival follow-up (i.e., date last known alive or of death) prior to the cutoff date for database lock for the final Clinical Study Report.
    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 months0
    E.8.9.1In the Member State concerned days0
    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: 15
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 3
    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) Yes
    F.1.2.1Number of subjects for this age range: 15
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 Patients
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 12
    F.4.2.2In the whole clinical trial 30
    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)
    as per protocol
    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 Decision2012-02-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-01-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-08-21
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