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    Summary
    EudraCT Number:2010-023077-19
    Sponsor's Protocol Code Number:CP14B012
    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:2010-12-14
    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 number2010-023077-19
    A.3Full title of the trial
    A Randomized Phase II Study of Imetelstat as Maintenance Therapy after Initial Induction Chemotherapy for Advanced Non-Small Cell Lung Cancer (NSCLC)
    A.4.1Sponsor's protocol code numberCP14B012
    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 SponsorGeron Corporation
    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 nameImetelstat sodium
    D.3.2Product code GRN163L
    D.3.4Pharmaceutical form Powder for 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.3.8INN - Proposed INNImetelstat sodium
    D.3.9.1CAS number 1007380-31-5
    D.3.9.2Current sponsor codeGRN163L
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number210
    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 Yes
    D.3.11.13.1Other medicinal product typeSynthetic oligonucleotide (with a 5’-conjugated C16 lipid attached through an aminoglycerol linker)
    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
    Non-small cell lung cancer
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10061873
    E.1.2Term Non-small cell lung cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To obtain a preliminary estimate of efficacy as defined by progression-free survival for patients with advanced NSCLC who receive four to six cycles of induction chemotherapy and are randomized to receive treatment with either:
    - Imetelstat maintenance therapy in addition to standard of care (bevacizumab or
    observation);
    − Standard of care alone (bevacizumab or observation)
    E.2.2Secondary objectives of the trial
    To assess the safety and tolerability of imetelstat as part of maintenance therapy
    following initial induction chemotherapy in patients with advanced NSCLC.
    To obtain a preliminary estimate of the response rate when imetelstat is used as part of maintenance therapy in patients with advanced NSCLC.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Signed informed consent.
    • Ability and willingness to comply with requirements of the study protocol.
    • Male or female, age 18 or over.
    • Histologically or cytologically confirmed diagnosis of NSCLC
    • Stage IV (using the 7th edition of AJCC, or wet IIIb / IV using the 6th edition), or
    recurrent locally advanced disease not amenable to radiation or surgery with curative
    intent, or are not amenable to concurrent chemoradiation.
    • Patients have completed four to six cycles of platinum-based chemotherapy doublet
    for first line, advanced NSCLC, with no evidence of disease progression according to
    RECIST version 1.1. Adjuvant chemotherapy greater than one year prior to
    progression is allowed.
    • Patients are willing and able to continue treatment with bevacizumab, if they received
    it with their platinum based chemotherapy.
    • ECOG performance status 0-1
    • Adequate bone marrow reserve as measured by ANC ≥ 1500/mm3, hemoglobin
    ≥ 9 g/dL, platelet count ≥ 75,000 μL. Must be measured ≥ 1 week after last
    transfusion of blood products and/or last dose of hematopoietic growth factor.
    • Prothrombin Time (PT) or INR or aPTT ≤ 1.5 x ULN.
    • Serum creatinine < 1.5 mg/dL or creatinine clearance > 45 mL/min.
    • Urinalysis with < 2+ protein or urinary excretion of < 2 g of protein/day (for patients
    to receive bevacizumab).
    • AST (SGOT) and ALT (SGPT) < 2.5 x the ULN, (AST (SGOT) and ALT (SGPT)
    < 5 x the ULN if documented liver metastases).
    • Serum bilirubin < 2.0 mg/dL (patients with Gilbert's syndrome: serum bilirubin < 3 x
    ULN).
    • Alkaline phosphatase < 2.5 x ULN (patients with documented liver or bone
    metastases, alkaline phosphatase ≤ 5 x ULN).
    • No other obvious related major organ toxicities which would compromise the
    patient’s ability to participate in a clinical trial of a novel agent.
    • Patients may have received prior radiation therapy for local or locally advanced
    disease providing that any clinically significant adverse effects associated with prior
    therapy have recovered to Grade 1 or less.
    • Women of childbearing potential must have a negative serum pregnancy test and
    agree to use effective birth control during and for 12 weeks after the last treatment
    with imetelstat.
    • Males must agree to use effective birth control for themselves or their partner during and for 12 weeks after the last treatment with imetelstat.
    E.4Principal exclusion criteria
    Patients who meet any of the following criteria will be excluded from screening and study entry:
    • Patients who are not eligible for induction therapy with a platinum based
    chemotherapy doublet
    • Patients who are scheduled to receive, or have received, pemetrexed or erlotinib as maintenance therapy.
    • Patients receiving bevacizumab must not have a recent history of hemoptysis ≥ ½
    teaspoon of red blood, or ≥ 2 g/24 hr urinary protein while receiving prior
    bevacizumab, or squamous cell histology.
    Patients will be excluded from being randomized if any of the following criteria apply:
    • Last dose of induction chemotherapy < 21 days prior to randomization or > 42 days prior to randomization
    • History of pulmonary hemorrhage (> 1 teaspoon) within the previous 4 weeks
    • Anti-platelet therapy within 2 weeks prior to first study drug administration, other
    than low dose aspirin prophylaxis therapy (baby aspirin).
    • Therapeutic anticoagulation therapy except for low dose warfarin (e.g., 1 mg by
    mouth per day).
    • Radiation therapy within 3 weeks prior to first study drug administration (palliative
    radiation therapy is allowed, provided that sites of bone marrow production, i.e. iliac
    crests are not in the radiation field).
    • Major surgery within 4 weeks prior to first study drug administration (central line
    placement is allowed)
    • Active central nervous system (CNS) metastatic disease. Patients with stable CNS
    disease following completion of radiation therapy and/or surgery are eligible.
    • Any other active malignancy
    • Active or chronically recurrent bleeding (e.g., active peptic ulcer disease)
    • Clinically significant infection
    • Active autoimmune disease requiring immunosuppressive therapy
    • Clinically significant cardiovascular disease or condition (listed in protocol).
    • Any other severe, acute, or chronic medical or psychiatric condition, laboratory
    abnormality, or difficulty complying with protocol requirements that may increase the
    risk associated with study participation or study drug administration or may interfere
    with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for the study
    E.5 End points
    E.5.1Primary end point(s)
    Progression-free survival, defined as the time from randomization to documented disease progression, as determined by the Investigator’s assessment according to RECIST criteria (version 1.1) or death from any cause, whichever occurs first.
    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 Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) 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.8.4.1Number of sites anticipated in Member State concerned5
    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 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
    In addition to last visit of the last subject, Geron may terminate the study 1) if the incidence of severity of adverse events indicates a potential health hazard to patients, 2) patient enrollment is unsatisfactory, 3) data recording is inaccurate or incomplete.
    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 days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months2
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 96
    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 Decision2011-02-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-02-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-07-08
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