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    Summary
    EudraCT Number:2009-014396-43
    Sponsor's Protocol Code Number:HN001 (TEMHEAD)
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-01-20
    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 ConcernedGermany - BfArM
    A.2EudraCT number2009-014396-43
    A.3Full title of the trial
    A single arm, open-label multicenter phase II trial of temsirolimus in patients with relapsed/ recurrent squamous cell cancer of the Head and Neck (HNSCC)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial of temsirolimus in patients with squamous cell cancer of the head and neck
    A.3.2Name or abbreviated title of the trial where available
    TEMHEAD
    A.4.1Sponsor's protocol code numberHN001 (TEMHEAD)
    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 SponsorMedical School Hannover
    B.1.3.4CountryGermany
    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 supportWyeth/Pfizer
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHannover Medical School
    B.5.2Functional name of contact pointDr. med. Viktor Grünwald
    B.5.3 Address:
    B.5.3.1Street AddressCarl-Neuberg-Str. 1
    B.5.3.2Town/ cityHannover
    B.5.3.3Post code30625
    B.5.3.4CountryGermany
    B.5.4Telephone number+495115329196
    B.5.5Fax number+495115328077
    B.5.6E-mailgruenwald.viktor@mh-hannover.de
    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 TORISEL
    D.2.1.1.2Name of the Marketing Authorisation holderWyeth Europa Ltd.
    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 nameTemsirolimus
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous drip use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTemsirolimus
    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) 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
    Patients with metastatic or local recurrenct squamous carcinoma of the head and neck (HNSCC) who have measurable progressive disease after platinum-based radiochemotherapy or recurrence or metastatic progressive disease after first line platinum-based chemotherapy. Failure of at least one line of cisplatin-based therapy and cetuximab is required.
    E.1.1.1Medical condition in easily understood language
    Patients with cancer of the head and neck who have progressive disease after radiochemotherapy or recurrence or metastatic progressive disease after first line chemotherapy.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10060121
    E.1.2Term Squamous cell carcinoma of head and neck
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to determine the efficacy (progression free rate at day 84
    [12 weeks]; PFR) of temsirolimus 25 mg i.v. once weekly in patients with relapsed or
    recurrent HNSCC after failure of platinum- and cetuximab-based regimens.
    E.2.2Secondary objectives of the trial
    - Time to progression (TTP)
    - The disease control rate (DCR: CR+PR+SD)
    - The over all survival rate (OS)
    - Safety and tolerability of temsirolimus (evaluating according to CTC 3.0 criteria)
    - Evaluation of predictive markers of tumor response in serum and tumor specimen
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Signed written informed consent must be given prior to study inclusion
    - Histological or cytological confirmed recurrent or metastatic squamous cell carcinoma
    of the head and neck (HNSCC)
    - Measurable progressive disease after platinum-based radiochemotherapy or
    recurrence or metastatic progressive disease after first line platinum-based
    chemotherapy
    - Patients with loco-regional recurrence need to be progression free for at least 6
    months after platinum-based radiochemotherapy, if locoregional recurrence is the
    only lesion
    - Cetuximab must have been included in at least one prior line of therapy
    - Prior exposure to a taxane is permitted
    - Disease is not amenable to surgery, radiotherapy or platinum-based chemotherapy
    - At least one measurable lesion according to RECIST (version 1.0) criteria
    - Age > 18 years
    - ECOG performance status 0-2
    - Brain metastases require completion of local therapy with discontinuation of steroids
    prior to start of teatment
    E.4Principal exclusion criteria
    - Live expectancy less than 3 months
    - Anticancer treatment during the last 30 days prior to start of treatment including
    systemic therapy, radiotherapy or major surgery
    - Participation in a clinical trial within the last 30 days prior to study treatment
    - Serious illness or medical condition other than the disease under study
    - Other malignancies within 3 years, with exception of HNSCC, history of a previous
    basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix
    - Inability to potentially complete follow up and treatment per protocol for
    psychological, familial, sociological or geographical reasons
    - Pregnancy or breast feeding
    - Known allergic/ hypersensitivity reaction to any component of the treatment
    - Concurrent treatment with oral anticoagulants
    - Uncontrolled diabetes: fasting serum glucose > 2.0 ULN
    - Active or uncontrolled infection
    E.5 End points
    E.5.1Primary end point(s)
    - progressive free rate (PFR) at treatment day 84 (12 weeks)
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks
    E.5.2Secondary end point(s)
    1) time to progression
    2) disease control rate
    3) overall survival rate
    4) safety and tolerablility of temsirolimus
    5) evaluation of predictive markers of tumor response in serum and tumor specimen
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) - 5) until end of follow-up period
    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 No
    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 No
    E.8.1.2Open No
    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.8.3 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 concerned7
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    Study treatment will continue until tumor progression or unless unacceptable toxicity is encountered.
    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 months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    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 No
    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) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    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)
    After end of protocol treatment, patients will be treated according to the local standards,
    which are not prespecified in the 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 Decision2010-02-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-02-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-03-12
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