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    Summary
    EudraCT Number:2005-003814-14
    Sponsor's Protocol Code Number:ML19498
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2006-01-17
    Trial 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 ConcernedSpain - AEMPS
    A.2EudraCT number2005-003814-14
    A.3Full title of the trial
    Pharmacodynamic study of Erlotinib (Tarceva) in patients with mestastatic or locally advanced Epidermoid carcinoma of the head and neck
    A.4.1Sponsor's protocol code numberML19498
    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 SponsorUnidad Integral de Investigación en Oncología, S.L.
    B.1.3.4CountrySpain
    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 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 Information not present in EudraCT
    D.2.1.1.1Trade name TARCEVA
    D.2.1.1.2Name of the Marketing Authorisation holderOSI Pharmaceuticals INC.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameErlotinib clorhidrato
    D.3.2Product code RO50-8231/OSI-774
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNErlotinib
    D.3.9.1CAS number 183319-69-9
    D.3.9.2Current sponsor codeRO50-8231/OSI-774
    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) 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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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.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 Information not present in EudraCT
    D.2.1.1.1Trade name TARCEVA
    D.2.1.1.2Name of the Marketing Authorisation holderOSI Pharmaceuticals INC.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameErlotinib clorhidrato
    D.3.2Product code RO50-8231/OSI-774
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNErlotinib
    D.3.9.1CAS number 183319-69-9
    D.3.9.2Current sponsor codeRO50-8231/OSI-774
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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
    Mestastatic or locally advanced Epidermoid carcinoma of the head and neck
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the relation between response rate and the number of CA repetition in the intron nr 1of the EGFR gene in patients with metastatic of locally advanced epidermoid head and neck carcinoma
    E.2.2Secondary objectives of the trial
    To determine relation between number of CA repetition in intron 1of the EGFR gene and time to progression and survival in patients with metastatic or locally advanced epidermoid head-neck cancer
    To determine relation between frequency and intensity of coetaneous toxicity and other toxicities and nr of CA repetition in intron 1 of the EGFR gene in patients with metastatic or locally advanced epidermoid head-neck cancer
    To compare grade of regulation of the p27 protein and phosphorilation state of EGFR protein in coetaneous byopsias in patients with metastatic or locally advanced epidermoid head-neck cancer and with different nr of CA repetitions in intron 1 of the EGFR gene in treatment with erlotinib
    To determine relation between treatment with erlotinib and efficacy, toxicity and pharmacodymanic effects in patients with metastatic or locally advanced epidermoid head-neck cancer and with different number of CA repetitions in intron 1 of the EGFR gene in treatment with erlotinib.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Aceptation of the patiens to participate in the trial with their written consent prior to the commencement of the trial-related procedures.
    Patients with a histological proven diagnosis of cancer of head and neck incurable with other treatments of cirugy and radiotherapy.The nor distinghised carcinomas and not queratinizados as linfoepiteliomas in aereas of cancer of parotida glándula except: Patients with cancer de squamous cell WHO tipo I of nasofaringe.
    Ages 18-70 years
    Life-expectancy >12 weeks
    Measurable disease,RECIST criteria
    Fulfifment of the treatment and the patiens must be geographically accessible for treatment and follow-up.
    ECOG 0-2
    If the patients have received a prior treatment:
    Chemotherapy: the patients musn,t have received more of 2 cycles of chemotherapy to the the treatment of the local disease and/or metastasic.The patients that have received the induction o chemoradiotherapy with a healing intention to local disease can participate in the trial if they have not received more of 2 cycles of chemotherapy to the recurrent disease. That treatment must have completed at least 14 days prior to the commencement of the trial.Every patients must have recovered of the toxic sever effects in relation with the prior treatment.The prior treatment of diana treatment such as inhibidores of tirosin quinasa and monoclonales antibodys.
    Radiotherapy:prior radiotherapy treatment is allowed if the patients
    have recovered of the toxic sever effects in relation the treatment before to start the trial.It must have been passed 14 days since the end of the radiotherapy treatment. The disease progression in a previous irradiated area must be demonstrated by byopsia or tomografic image.
    previous surgery: it is possible it the injury has healed and the surgery has been performed 14 days before the start of the trial
    TArget lesion >=20mm (or >=10mm CT spiral). If the area is a previous irradiated area it must be documented the disease progression or to be present a residual cancer demonstrated by byopsia
    Optima organic function according to: a)adequate medular function, ANC>1.5x109L, platelets>100x109L and hemoglobin>9g/dl
    b)adequate hepatic and renal function
    negative pregnancy test
    Good cardiovascular function
    E.4Principal exclusion criteria
    Not writen informed consent.
    Another medical treatment with experimental drugs or another simultaneous chemotherapeutic drugs during the study.
    Patients with different histologic diagnosis of epidermoid carcinoma.
    Another previous neoplasia, except basal cell carcinoma or squamous carcinoma of skin, previous treated; resecate cervix carcinoma.
    Pregnant or lactancy women.
    Patiens with active infection
    Serious concomitant disease or patients with life expectancy smallest than their neoplasic disease.
    Serious psychiatric disease not controled.
    Patients unable to take oral medication or patients whose take intravenous food or patients with an intervention which interferes to the apsortion or patients with active peptic ulcer.
    Follow-up not possible.
    Symptomatic unstable metastasic brain, not controled with esteroids, life potential menace or with radiotherapy in the 14 days before the beginning of the study.
    Any disease, metabolic malfunction, abnormal physical exploration or analytic information who suggest an inconvenient condition for the administration of the trial medication that might affect the study results or increase the risk of patient treatment.
    Frequent vomits or medical disease who interferes to oral ingestion of medicaments.
    E.5 End points
    E.5.1Primary end point(s)
    To determine the relation between response rate and the number of CA repetition in the intron nr 1of the EGFR gene in patients with metastatic of locally advanced epidermoid head and neck carcinoma
    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 Information not present in EudraCT
    E.6.11Pharmacogenomic Yes
    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 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 No
    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 Information not present in EudraCT
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months24
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-01-17. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state49
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 49
    F.4.2.2In the whole clinical trial 49
    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 Decision2006-03-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-01-03
    P. End of Trial
    P.End of Trial StatusOngoing
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