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    Summary
    EudraCT Number:2009-012983-14
    Sponsor's Protocol Code Number:DMS32212R
    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:2009-07-21
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2009-012983-14
    A.3Full title of the trial
    Randomized, multicenter, double-blind, phase 3 trial of Tavocept versus Placebo in patients with newly diagnosed or relapsed advanced (stage IIIB/IV) primary adenocarcinoma of the lung treated with docetaxel or paclitaxel plus cisplatin
    A.4.1Sponsor's protocol code numberDMS32212R
    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 SponsorBioNumerik 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 nameTavocept
    D.3.2Product code BNP7787
    D.3.4Pharmaceutical form 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.3.9.1CAS number 16208-15-8
    D.3.9.2Current sponsor codeBNP7787
    D.3.9.3Other descriptive nameDisodium, dithio-bismercaptoethansulfonate; 2,2'-thio-bisethanesulphonic acid, disodium salt
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Newly diagnosed or relapsed advanced (Stage IIIB/IV) primary adenocarcinoma of the lung
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10025031
    E.1.2Term Lung adenocarcinoma
    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 if the co-administration of Tavocept with first-line combination chemotherapy (paclitaxel or docetaxel plus cisplatin) as compared to placebo can result in a significant increase in overall survival in the defined patient population.
    E.2.2Secondary objectives of the trial
    To determine if Tavocept co-administration concurrently prevents and/or mitigates cisplatin-induced renal toxicity and other common chemotherapy-induced toxicities, including anemia and emesis in patients.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Pharmacokinetics assesment at selected sites (min. 100 patients)
    E.3Principal inclusion criteria
    1. Patients with confirmed histopathological or cytological diagnosis of inoperable
    advanced (stage IIIB/IV) primary adenocarcinoma (including bronchioalveolar
    cell carcinoma) of the lung.
    2. All patients must have documented stage IIIB disease with malignant pleural or
    pericardial effusions or stage IV disease.
    3. Patients may have newly diagnosed or recurrent/relapsed disease.
    4. No form of any prior systemic treatment for non-small cell lung cancer, including
    chemotherapy, immunotherapy (e.g., monoclonal antibodies, vaccines), hormonal
    therapy (excluding dexamethasone or corticosteroids), targeted therapies (including EGFR inhibitors), or investigational drugs.
    5. Prior radiation therapy is allowed, provided that at least one (1) area of
    measurable (by CT scan) or evaluable disease by RECIST (Version 1.1) that has
    not been subject to prior irradiation.
    6. Prior prophylactic cranial irradiation (PCI) or radiation therapy are allowed provided that any such therapy is completed and any radiation-induced sequelae
    are recovered at least 21 days before receiving study treatment.
    7. Patients with an ECOG performance status of 0 or 1.
    8. Patients who are at least 18 years of age.
    9. Patients with documented stable CNS metastases with no cognitive deficits, or
    progressive sensory or motor deficits or seizures during the last 21 days are
    eligible. Patients must have discontinued anti-seizure medications and steroids at
    least 21 days prior to patient randomization.
    10. Patients must have fully recovered from any prior major surgical or diagnostic
    staging procedure (e.g., thoracotomy, mediastinoscopy), and have a post-operative
    status of at least 30 days.
    11. Patients must have adequate bone marrow, adequate hepatic function, and a
    baseline serum creatinine level documented by specific laboratory criteria:
    • Absolute neutrophil count (ANC) ≥ 1.5 × 109/L
    • Hemoglobin ≥ 10 g/dL
    • Platelet count ≥ 100 × 109/L
    • Total bilirubin < the upper limit of normal (ULN)
    • Aspartate aminotransferase (AST/SGOT) ≤ 1.5 × ULN
    • Alanine aminotransferase (ALT/SGPT) ≤ 1.5 × ULN
    • Alkaline phosphatase ≤ 2.5 × ULN
    • Baseline serum creatinine level no greater than 1.5 mg/dL or 133 μmol/L.
    • Magnesium ≥ 1.7 mg/dL
    12. Female patients of child-bearing potential must have a negative pregnancy test,
    and must agree to use an acceptable contraceptive method during the study. Male
    patients with partners of child-bearing potential must also agree to use an adequate
    method of contraception.
    13. Patients must have been disease-free at least 2 years for other malignancies,
    excluding:
    • Prior surgical resection of primary adenocarcinoma of the lung that occurred
    more than one year prior to randomization,
    • Curatively-treated basal cell carcinoma,
    • Squamous cell carcinoma of the skin, or
    • Carcinoma in situ of the cervix.
    E.4Principal exclusion criteria
    1. Patients with small cell, squamous cell, large cell, or undifferentiated, or any form
    of mixed (e.g., small cell and adenocarcinoma or squamous and adenocarcinoma)
    histopathological or cytological diagnosis of primary lung cancer.
    2. Stage IIIB disease without malignant pleural or pericardial effusions, or Stage IIIIA
    disease.
    3. Patients with adenocarcinoma arising from any primary sites other than the lung.
    4. Patients with recent onset (within 6 months of randomization) of congestive heart
    failure (New York Heart Association Classification Class II or greater), angina
    pectoris, unstable angina pectoris, uncontrolled ventricular tachycardia,
    myocardial infarction, stroke, or transient ischemic attacks.
    5. Patients with unstable CNS metastases (characterized by progressive
    sensory/motor impairment, cognitive/speech impairment, or seizure activity
    within 21 days of initial study treatment.
    6. Patients who do not have at least one (1) measurable or non-measurable but
    assessable disease site that has not been previously irradiated.
    7. Patients who are known to be HIV-positive.
    8. Patients with active infections (including viral, fungal, bacterial, rickettsial,
    mycobacterial, or parasitic), uncontrolled high blood pressure, uncontrolled
    diabetes mellitus, uncontrolled seizures (not due to CNS metastases) within the
    last 6 months, or other serious underlying medical condition.
    9. Patients with documented hypersensitivity to any of the study medications or
    supportive agents that may be used.
    10. Patients who are pregnant or are breastfeeding.
    11. Patients with a life expectancy of less than 5 months.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is overall survival (OS); defined as the time period from the date of patient randomization to the date of death due to any cause.
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    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 Yes
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA27
    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 Yes
    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
    The end of the trial is defined as 3 years after last patient is randomized to the study (see protocol)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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 years4
    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.1.3Elderly (>=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 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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 170
    F.4.2.2In the whole clinical trial 575
    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 Decision2009-10-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-10-07
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2013-04-22
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