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    Summary
    EudraCT Number:2007-006193-29
    Sponsor's Protocol Code Number:KOS-1584-203
    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:2008-10-28
    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 number2007-006193-29
    A.3Full title of the trial
    OPEN LABEL, MULTI-CENTER, PHASE 2 STUDY OF KOS-1584 IN PATIENTS
    WITH ADVANCED OR METASTATIC STAGE IIIB/IV NON-SMALL CELL LUNG CANCER
    PREVIOUSLY TREATED WITH FIRST-LINE CHEMOTHERAPY
    A.4.1Sponsor's protocol code numberKOS-1584-203
    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 SponsorKOSAN BIOSCIENCES, 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 nameKOS-1584
    D.3.2Product code KOS-1584
    D.3.4Pharmaceutical form Intravenous 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 INN(E)-9,10-didehydroepothilone D
    D.3.9.1CAS number 350493-61-7
    D.3.9.2Current sponsor codeKOS-1584
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5.5
    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
    Advanced or Metastatic Stage IIIB/IV Non-Small Cell Lung Cancer
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level PT
    E.1.2Classification code 10029522
    E.1.2Term Non-small cell lung cancer stage IV
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level PT
    E.1.2Classification code 10029521
    E.1.2Term Non-small cell lung cancer stage IIIB
    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 Objective Response Rate (ORR) of KOS-1584 as a single agent, administered weekly for 2 weeks out of every 3 weeks intravenously in patients with stage IIIB/IV NSCLC whose disease has progressed following initial chemotherapy
    E.2.2Secondary objectives of the trial
    To evaluate KOS-1584 for Progression Free Survival (PFS), Time To Progression (TTP), Time To Treatment Failure (TTF), time to response, duration of response, and overall survival.
    To evaluate separately the safety of KOS-1584.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Current diagnosis of histologically or cytologically proven NSCLC, Stage IIIB or Stage IV, according to the American Joint Committee on Cancer (AJCC) staging system. Disease must not be amenable to curative therapy either by maximally feasible surgical resection or radiotherapy. Eligible patients must have received only one prior chemotherapy regimen for Stage IIIB/IV NSCLC.
    2. Age greater than or equal to 18 years.
    3. ECOG performance status 0 or 1.
    4.Radiographic or physical examination evidence of at least one site of unidimensionally-measurable disease, as per RECIST criteria. Tumor measurements must be assessed by RECIST within 28 days prior to first study drug administration.
    5. All clinically significant adverse events, excluding alopecia, of any prior chemotherapy, surgery or radiotherapy must have resolved to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 Grade less than or equal to 1. A minimum of 3 weeks must occur between last administration of chemotherapy, radiotherapy, or surgery and first study drug administration.
    6. The following laboratory results, within 10 days of first study drug administration:
    Hemoglobin greater than or equal to 8.5 g/dL (85 g/L)
    Absolute neutrophil count greater than or equal to 1.5 x 10 to the 9/L
    Platelet count greater than or equal to 75 x 10 to the 9/L
    Serum bilirubin less than or equal to 1.5 x ULN
    AST and ALT less than or equal to 2.5 x ULN (less than or equal to 5 x ULN in case of hepatic metastases)
    7. Women of child bearing potential: negative pregnancy test (serum or urine). Female patients must be >1 year postmenopausal, surgically sterile or they must agree to use a physical method of contraception. Male patients must be surgically sterile or must agree to use an acceptable method of contraception.
    8. Signed informed consent.
    E.4Principal exclusion criteria
    1. Neurological disease (including but not limited to peripheral sensory or motor neuropathy, seizures, gait disturbances, or tremors/involuntary movements) of CTCAE Grade greater than or equal to 2 due to any cause at time of screening; pre-existing painful neuropathy which at the time of screening is of CTCAE Grade greater than or equal to 1.
    2. Prior treatment with an epothilone.
    3. Pre-existing diarrhea uncontrolled with supportive care. Prior hemorrhagic diarrhea due to ulcerative colitis, inflammatory bowel disease or other cause. Active, uncontrolled peptic ulcer disease (patients maintained with omeprazole, ranitidine or famotidine are acceptable to enroll).
    4. Presence of clinically or radiologically detectable (by physical examination) third-space fluid collections (e.g., pleural and/or peritoneal effusions) unless these can be controlled by drainage at a frequency of not more than once every 2 weeks prior to first study drug administration.
    5. Documented hypersensitivity reaction (NCI CTCAE Grade greater than or equal 2) to prior therapy containing hydroxypropyl-β-cyclodextrin, ethanol, and propylene glycol.
    6. Current history of ethanol abuse or concomitant administration of Antabuse® (disulfiram).
    7. Pregnant or breast-feeding women.
    8. Known CNS metastases. A patient with focal neurological deficits identified during the screening period must undergo baseline CT or MRI with contrast of the head to investigate possible CNS metastases.
    9. Administration of any investigational agent (therapeutic or diagnostic) including any investigational compound for the treatment of NSCLC, within 3 weeks prior to first study drug administration.
    10. Any medical condition that would impose excessive risk to the patient. Examples of such conditions include congestive heart failure of Class III or IV of the NYHA classification, uncontrolled dysrhythmia, infection requiring parenteral or oral anti-infective treatment, any altered mental status or any psychiatric condition that would interfere with the understanding of the informed consent.
    11. Patients with previous malignancies unless free of recurrence for at least 5 years except cured basal cell carcinoma of the skin or treated carcinoma-in-situ.
    E.5 End points
    E.5.1Primary end point(s)
    Response rate (based on tumor measurements according to RECIST criteria)
    Duration of response, time to response
    PFS, TTP, TTF, survival (both overall and patients with CR/PR/Stable Disease (SD))
    Adverse events reported by the patients or noted during physical examination and laboratory tests results.
    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 Yes
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Yes
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA6
    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
    Provided in the Protocol
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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 years2
    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) 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 state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 23
    F.4.2.2In the whole clinical trial 48
    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 Decision2008-05-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-06-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-08-07
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