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    The EU Clinical Trials Register currently displays   39188   clinical trials with a EudraCT protocol, of which   6421   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2005-006022-29
    Sponsor's Protocol Code Number:A6181058
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2008-03-18
    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 number2005-006022-29
    A.3Full title of the trial
    RANDOMIZED, DOUBLE-BLIND, PHASE 2 STUDY OF ERLOTINIB WITH OR WITHOUT SU011248 IN THE TREATMENT OF METASTATIC NON-SMALL CELL LUNG CANCER
    A.4.1Sponsor's protocol code numberA6181058
    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 SponsorPfizer Inc. - 235 East 42nd Street - New York - 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 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 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.3.2Product code SU011248 L-Malate Salt
    D.3.4Pharmaceutical form Capsule, hard
    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 INNSunitinib Malate
    D.3.9.1CAS number 341031-54-7
    D.3.9.2Current sponsor codeSU011248
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number12,5 to 50
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Tarceva
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration 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.3.1Product nameTarceva
    D.3.4Pharmaceutical form Film-coated 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 Hydrochloride
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number25 to 150
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Platinum-refractory, locally advanced or metastatic non-small cell lung cancer (NSCLC)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.0
    E.1.2Level VTb
    E.1.2Classification code 10061873
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level PT
    E.1.2Classification code 10061873
    E.1.2Term Non-small cell lung cancer
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the progression-free survival (PFS) for SU011248 plus erlotinib versus placebo plus erlotinib in patients with platinum-refractory NSCLC.
    E.2.2Secondary objectives of the trial
    • To compare the objective response rate (ORR) for SU011248 plus erlotinib versus placebo plus erlotinib as treatment for platinum-refractory NSCLC.
    • To compare measures of duration of tumor control and survival.
    • To compare the safety and tolerability of SU011248 plus erlotinib versus placebo plus erlotinib.
    • To evaluate the plasma pharmacokinetics of erlotinib and SU011248 and its active metabolite SU012662 when these drugs are co-administered.
    • To explore the relationships of cancer biomarkers with cancer- and treatment-related outcomes.
    • To compare patient reported outcomes (PRO) including health-related quality of life
    (HRQOL) and lung cancer-related symptoms in patients treated with SU011248 plus erlotinib versus placebo plus erlotinib.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    TITLE:
    RANDOMIZED, DOUBLE-BLIND, PHASE 2 STUDY OF ERLOTINIB WITH OR WITHOUT SU011248 IN THE TREATMENT OF METASTATIC NON-SMALL CELL LUNG CANCER

    Version and Date: Final - 2 September 2005

    STUDY OBJECTIVES:
    The primary objective of this additional research component is to allow for the collection, storage, and use of samples to investigate possible associations between genetic variation in relation to response to the combination of erlotinib and SU011248 and in relation to characteristics of Non Small Cell Lung Cancer (NSCLC) and related conditions. Scientific information about these differences among groups of subjects can help researchers to better understand the response of subjects to investigational drugs such as SU011248 and to learn more about conditions such as NSCLC.

    The second objective is to collect, store, and use the samples as controls in genetic investigations of the causes, natural history, and other aspects of important diseases and conditions for which Pfizer is researching new or improved drug therapies.
    E.3Principal inclusion criteria
    1. Histologically proven diagnosis of NSCLC.
    2. Disease that is locally advanced (Stage IIIB with malignant effusion), metastatic (Stage IV), or recurrent (after treatment for Stage IIIB with malignant effusion or Stage IV NSCLC).
    3. Prior treatment with 1 or 2 chemotherapy regimens including a platinum-based regimen for advanced disease (Stage IIIB with malignant effusion or Stage IV).
    4. Evidence of unidimensionally measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST).
    5. Radiographic evidence of disease progression during or following treatment in the advanced disease setting confirmed by the Principal Investigator prior to enrollment in the study.
    6. Formalin-fixed, paraffin-embedded tumor tissue available from patients enrolling into the randomized component of this study. (Paired samples collected at the time of the most recent recurrence and at the initial diagnosis are optimal, though samples collected at any time are acceptable).
    7. Male or female, 18 years of age or older.
    8. ECOG performance status 0 or 1.
    9. Resolution of all acute toxic effects of prior therapy or surgical procedures to grade ≤1 (except alopecia).
    10. Adequate organ function as defined by the following criteria:
    • NCI CTCAE severity ≤ 2 for dyspnea
    • Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤2.5 x upper limit of normal (ULN), or AST and ALT ≤5 x ULN if liver function abnormalities are
    due to underlying malignancy
    • Total serum bilirubin ≤1.5 x ULN
    • Serum albumin ≥3.0 g/dL
    • Absolute neutrophil count (ANC) ≥1500/µL
    • Platelets ≥100,000/µL
    • Hemoglobin ≥9.0 g/dL
    • Serum creatinine ≤1.5 x ULN
    11. Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrollment.
    12. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
    E.4Principal exclusion criteria
    1. Prior treatment with >2 systemic chemotherapy-based regimens for advanced disease (Stage IIIB with malignant effusion or Stage IV).
    2. Prior treatment with any receptor tyrosine kinase inhibitors, VEGF inhibitors, or other angiogenic inhibitors (including but not limited to SU011248, erlotinib, gefitinib, or thalidomide). Note: Patients previously treated with bevacizumab or an IGFR inhibitor will be considered eligible for study entry.
    3. Major surgery, radiation therapy, or systemic therapy within 4 weeks of starting the study treatment.
    4. Prior high-dose chemotherapy requiring hematopoietic stem cell rescue.
    5. Prior radiation therapy to >25% of the bone marrow.
    6. Evidence of hemoptysis <4 weeks of starting study treatment. Patients with blood-tinged or blood-streaked sputum will be permitted on study if the hemoptysis amounts to less than 5 mL of blood per episode and less than 10 mL of blood per 24-hour period in the best estimate of the investigator.
    7. History of or known brain metastases, spinal cord compression, carcinomatous meningitis, or new evidence of brain or leptomenengeal disease on screening CT or MRI scan.
    8. Diagnosis of any second malignancy within the last 3 years, except basal cell carcinoma, squamous cell skin cancer, or in situ carcinoma that has been adequately treated.
    9. Any of the following within the 12 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident including transient ischemic attack, or pulmonary embolism.
    10. Ongoing cardiac dysrhythmias of NCI CTCAE grade ≥2, atrial fibrillation of any grade, or QTc interval >450 msec for males or >470 msec for females.
    11. Hypertension that cannot be controlled by medications (>150/100 mmHg despite optimal medical therapy).
    12. Ongoing treatment with therapeutic doses of warfarin (however low dose warfarin up to 2 mg daily for deep vein thrombosis prophylaxis is allowed during the Phase 2 component of this study but not during the lead-in portion).
    13. Known human immunodeficiency virus (HIV) infection.
    14. Current treatment on another therapeutic clinical trial.
    15. Pregnancy or breastfeeding.
    16. Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, 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)
    Progression-Free Survival (PFS)
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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) Yes
    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.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    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
    Patients should continue to receive treatment as assigned at randomization until RECIST-defined disease progression or for up to 18 cycles. At the time of progression or after 18 cycles on study patients will be unblinded to treatment assignment and all patients offered continued access to SU011248 through participation on a separate protocol at the discretion of the investigator.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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.1.3Elderly (>=65 years) Yes
    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 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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 136
    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 see section 6 of 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 Decision2008-06-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-06-04
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
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