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    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   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:2007-000371-42
    Sponsor's Protocol Code Number:3066K1-139-US
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-08-06
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2007-000371-42
    A.3Full title of the trial
    A Phase I/II Safety and Exploratory Pharmacodynamic Study of Intravenous Temsirolimus (CCI-779) in Pediatric Subjects with Relapsed/Refractory Solid Tumors
    A.4.1Sponsor's protocol code number3066K1-139-US
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorWyeth Research Division of Wyeth Pharmaeuticals 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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    B.Sponsor: 2
    B.1.1Name of SponsorWyeth Research Division of Wyeth Pharmaceuticals 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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameTemsirolimus IV
    D.3.2Product code CCI-779
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNTemsirolimus
    D.3.9.1CAS number 162635043
    D.3.9.2Current sponsor codeCCI-779
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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/refractory neuroblastoma,high-grade glioma, and rhabdomyosarcoma.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10018338
    E.1.2Term Glioma
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10029260
    E.1.2Term Neuroblastoma
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10039022
    E.1.2Term Rhabdomyosarcoma
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Part 1 (Part 1 is now closed):
    Primary Objective - To evaluate the safety of IV temsirolimus given once weekly to children with solid tumors with disease that is recurrent or refractory to standard therapy or for whom standard therapy is not available.

    Part 2:
    Primary objective - To obtain preliminary information on the anti-tumor activity of IV temsirolimus in children with relapsed/refractory neuroblastoma, high-grade glioma, and rhabdomyosarcoma. Anti-tumor activity will be assessed by determining the percentage of subjects exhibiting objective response (CR + PR) within 12 weeks.
    E.2.2Secondary objectives of the trial
    Part 1 (Part 1 is now closed):
    1) To identify the maximum tolerated dose or a biologically effective dose of IV temsirolimus when administered once weekly.
    2) To obtain preliminary information on the anti-tumor activity of IV temsirolimus.
    3) To determine the single- and multiple-dose pharmacokinetics of temsirolimus in children with once-weekly IV treatment.
    4) To determine the effects of IV temsirolimus on changes in the mTOR signaling pathway in the PBMCs.

    Part 2:
    1) To verify the safety of the selected dose.
    2) To evaluate the percentage of subjects exhibiting freedom from progression (disease stabilization defined as CR+VGPR+MR+PR+SD for subjects with neuroblastoma and CR+PR+SD for all other subjects) at 3 months.
    3) To determine the multiple-dose pharmacokinetics of temsirolimus in children with once-weekly IV treatment.
    4) To determine the effects of IV temsirolimus on changes in the mTOR signaling pathway in the bone marrow.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Part 1 only: (Now closed)
    1. Subjects with a histological diagnosis of advanced cancer (solid tumors or central nervous system [CNS] tumors) with disease that is recurrent or refractory to standard therapy or for whom standard therapy is not available (histological confirmation waived for brains team gliomas and optic pathway tumors).
    2. Evaluable disease.

    Part 2 only:
    1. Subjects with a histologically confirmed diagnosis of refractory or relapsed:
    - Neuroblastoma
    - High-grade gliomas: gliobalstoma multiforme, anaplastic astrocytmas, and other high-grade gliomas (histological confirmation waived for brain stem gliomas)
    - Rhabdomyosarcoma

    2. Measurable disease (for subjects with neuroblastoma, evaluable disease as determined by a positive metaiodobenzylguanidine (MIBG) scan will also be permitted).

    Part 1 and Part 2:

    1. At least 3 months since prior autologous or allogenic bone marrow transplantation (BMT) or stem cell transplant (SCT) at the time of study entry.
    2. Prior Radiotherapy:
    - at least 2 weeks since prior local radiation therapy at the time of study entry
    - at least 3 months since prior craniospinal radiotherapy at the time of study entry
    - at least 6 months since prior radiotherapy to: whole abdomen or pelvis, whole lungs, >25% of bone marrow reserve, or total body irradiation at the time of study entry
    3. At least 3 weeks since prior chemotherapy (6 weeks since nitrosoureas) at the time of study entry
    4. At least 3 weeks since prior immunotherapy at the time of study entry
    5. At least 3 weeks since any other prior investigational therapy at the time of study entry. Investigational therapy is defined as treatment that is not approved for any indication
    6. Age: 1-21 years or up to pediatric age limit as defined by local regulations at the time of study entry
    7. Lansky performance status 60%-100% for subjects aged 1 to 10 or Karnofsky performance status 60%-100% for subjects aged 11 to 21 or up to pediatric age limit as defined by local regulations
    8. Absolute Neutrophil Count (ANC) >= 1,000/mm3, platelet count >=75,000/mm3 (>= 50,000/mm3 for subjects with bone marrow involvement), and hemoglobin (Hgb) >=8 g/dL (transfusion of packed red cells is permitted if subject is known to have bone marrow involvement).
    9. Adequate renal function based on either of the following criteria:
    - creatinine clearance (estimated from the Schwartz formula) >= lower limit for age, or
    - serum creatinine concentration <=2x normal for age.
    10. Adequate hepatic function: Bilirubin <=1.5 x institutional upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <=3 x institutional ULN.
    11. Life expectancy of at least 2 months.
    12. Subjects of childbearing potential or with partners of childbearing potential must be willing to use a reliable method of birth control during entire course of study and for 12 weeks after study completion.
    13. Signed and dated, Independent Ethics Committee or institutional review board (IRB) approved informed consent form (and documented assent for subjects of appropriate age as required by each institution or local regulation) before any screening procedures not considered standard-of-care are performed
    E.4Principal exclusion criteria
    1. Subjects known to be human immunodeficiency virus (HIV) positive
    2. Active infection or serious intercurrent illness
    3. Subjects with known hepatitis C or known active hepatitis B
    4. Pulmonary hypertension or pneumonitis
    5. Any other major illness which in the investigator’s judgment, will substantially increase the risk associated with the subject’s participation in this study
    6. Concomitant therapy with any other investigational therapy
    7. Subjects receiving enzyme-inducing anticonvulsants
    8. Major surgery within 6 weeks prior to study entry
    9. Pregnant or lactating women
    10. Known hypersensitivity to any of the components in the temsirolimus infusion or other medical reasons for not being able to receive adequate pre-medication
    11. Unwillingness or inability to comply with procedures required in this protocol
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of Part 2 of this study is objective response (CR+PR) rate within 12 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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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
    phase I/II trial
    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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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 visit of last subject
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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.1.1.5Children (2-11years) Yes
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.2Adults (18-64 years) Yes
    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
    Paediatric patients
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 95
    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)
    please refer to 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 Decision2007-10-03
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-01-04
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