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    The EU Clinical Trials Register currently displays   36091   clinical trials with a EudraCT protocol, of which   5934   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2014-000199-25
    Sponsor's Protocol Code Number:009436
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-04-11
    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 ConcernedUK - MHRA
    A.2EudraCT number2014-000199-25
    A.3Full title of the trial
    A Phase II, randomised, open-label study of Gemcitabine/Carboplatin first-line chemotherapy in combination with or without the antisense oligonucleotide Apatorsen (OGX-427) in advanced squamous cell lung cancers
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    CEDAR
    A.3.2Name or abbreviated title of the trial where available
    CEDAR
    A.4.1Sponsor's protocol code number009436
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorQueen Mary, University of London
    B.1.3.4CountryUnited Kingdom
    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 supportOncoGenex Technologies Inc.
    B.4.2CountryCanada
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationQueen Mary, University of London
    B.5.2Functional name of contact pointCEDAR Trial Coordinator
    B.5.3 Address:
    B.5.3.1Street AddressCentre for Experimental Cancer Medicine, Barts Cancer Institute
    B.5.3.2Town/ cityOld Anatomy Building, Charterhouse Square, London
    B.5.3.3Post codeEC1M 6BQ
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number02078828490
    B.5.5Fax number02078828409
    B.5.6E-mailbci-CEDAR@qmul.ac.uk
    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 nameApatorsen (OGX-427)
    D.3.4Pharmaceutical form Infusion
    D.3.4.1Specific paediatric formulation No
    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 INNApatorsen (OGX-427)
    D.3.9.1CAS number 915443-09-3
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25.00
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Advanced squamous cell lung cancer
    E.1.1.1Medical condition in easily understood language
    Lung Cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    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
    The Primary Objective of this study is to estimate the clinical benefit of Gemcitabine and Carboplatin in combination with Apatorsen (OGX-427) compared to Gemcitabine and Carboplatin chemotherapy alone in patients previously untreated advanced squamous cell lung cancer
    E.2.2Secondary objectives of the trial
    1. Assess the clinical activity, by response rate (RECIST 1.1), clinical benefit rate, and duration of response of gemcitabine/carboplatin + Apatorsen compared to gemcitabine/carboplatin alone

    2. Establish the safety and tolerability of gemcitabine/carboplatin + Apatorsen compared to gemcitabine/carboplatin alone

    3. Evaluate drug exposure of gemcitabine/carboplatin + Apatorsen
    4. Estimate the overall survival benefit of gemcitabine/carboplatin + Apatorsen compared to gemcitabine/carboplatin alone

    5. Compare the differences in health-related quality of life (HRQL) and symptoms for patients by treatment assignment
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1 Written informed consent prior to admission to this study
    2 Histologically confirmed squamous cell lung cancer; patients with adenosquamous or mixed histology are not eligible for this study
    3 Stage IIIB disease that is unsuitable to radio-chemotherapy or Stage IV disease or recurrent NSCLC; recurrent disease must not be amenable to resection or radical radiotherapy with curative intent.
    4 Patients must have:
    • at least one lesion, not previously irradiated, that can be measured accurately at baseline as ≥10 mm in the longest diameter (except lymph nodes which must have short axis ≥15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) which is suitable for accurate repeated measurements
    OR
    •lytic or mixed (lytic + sclerotic) bone lesions in the absence of measurable disease as defined above; NOTE: patients with sclerotic/osteoblastic bone lesions only in the absence of measurable disease are not eligible
    5. Willing to donate archival diagnostic tissue for translational research, if available.
    6. Haematologic and biochemical indices within the ranges shown below. These measurements must be performed within one week prior to randomisation
    • ANC ≥1.5 x 109/L;, platelet count ≥100 x 109/L,
    • Serum creatinine < 1.5 times the upper limit of normal (ULN)
    • Bilirubin level < 1.5 X ULN
    • AST or ALT <3.0 X ULN or <5 X ULN in the presence of liver metastases
    7. ECOG performance status 0-2
    8. Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who has had a hysterectomy, bilateral oophorectomy, bilateral tubular ligation or is post-menopausal (total cessation of menses for ≥ 1 year; if the patient is of childbearing potential, she must have a negative serum pregnancy test within 2 weeks prior to the first dose of study treatment, preferably as close to the first dose as possible, and agrees to use adequate contraception (for example, intrauterine device [IUD], birth control pills unless clinically contraindicated, or barrier device) beginning 2 weeks before the first dose of investigational product and for 28 days after the final dose of investigational product.Male patients must be surgically sterile or agree to use adequate contraception
    9.Male or Female aged ≥18 years
    E.4Principal exclusion criteria
    Patients meeting any of the following exclusion criteria are not to be enrolled in the study.
    1. Symptomatic CNS involvement or CNS involvement requiring steroid therapy; patients with treated brain metastases that are asymptomatic and have been clinically stable for 1 month will be eligible for protocol participation


    2. Previous systemic treatment for lung cancer (exception for patients with recurrent disease: adjuvant chemotherapy is allowed as long as this was finished at least 1 year prior to enrolment and did not contain gemcitabine)

    3. Known tumour EGFR mutation, unless contraindication to EGFR-directed therapy

    4. Known tumour ALK rearrangements, unless contraindication to Alk-directed therapy or Alk-directed therapy not available 1

    5. Pre-existing sensory or motor polyneuropathy ≥ Grade 2 according to NCI CTCAE

    6. Significant cardiovascular disease, such as

    •History of myocardial infarction, acute coronary syndromes (including unstable angina), or history of coronary angioplasty/stenting/bypass grafting within past 6 months.

    • History of symptomatic congestive heart failure (CHF) New York Heart Association (NYHA) Classes III-IV or LVEF <50% by either ECHO or MUGA within past 6 months.

    • Severe cardiac arrhythmia requiring medication or severe conduction abnormalities

    • Poorly controlled hypertension (resting diastolic blood pressure >115 mmHg)

    • Clinically significant valvular disease, cardiomegaly, ventricular hypertrophy, or cardiomyopathy

    7. Active second malignancy (except non-melanomatous skin cancer): active secondary malignancy is defined as a current need for cancer therapy or a high possibility (>30%) of recurrence during the study.

    8. Concurrent treatment with other experimental drugs or participation in another clinical trial with any investigational drug within 30 days prior to study entry.

    9. Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the investigator’s opinion, gives reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, may affect the interpretation of the results, render the patient at high risk from treatment complications or interferes with obtaining informed consent.

    10. Psychological, familial, sociological or geographical conditions that do not permit compliance with the study protocol.

    11.Pregnant or nursing women

    12.Male or Female aged <18 years
    E.5 End points
    E.5.1Primary end point(s)
    The Primary outcome measure for the study is progression free survival (PFS).

    PFS is defined as the time from randomisation to disease progression or relapse (as assessed by the site radiologist and/or investigator, using RECIST, Version 1.1) or death on study from any cause (defined as death within 30 days of the last study treatment), whichever occurs first. For patients who have not died or experienced disease progression at the end of study, PFS will be censored on the last date the patient was known to be progression free.
    E.5.2Secondary end point(s)
    secondary Efficacy Endpoints:

    Objective response:

    RECIST 1.1 criteria will be used to assess response. Objective response will be calculated in patients with measurable disease at baseline. Patients without measurable disease at baseline will not be included in this analysis. Patients without a post-baseline tumour assessment will be considered to be non-responders. An estimate of the objective response rate and 95% CIs (Blyth–Still–Casella) will be calculated for each treatment arm. CIs for the difference in tumour response rate will be calculated. The relative risk (treatment: control) will be reported along with the associated 95% confidence interval. Statistical inference will be evaluated using Chi-square statistic; the Fisher’s exact test may be used if the expected counts in some cells are small.

    Change in tumour size at 12 weeks:

    Change in tumour size at 12 weeks is based on RECIST measurements taken at baseline and at week 12. Tumour size is the sum of the diameters of the target lesions (TL) that have been selected at baseline. Baseline for RECIST is defined to be the last evaluable assessment prior to starting treatment. The change in tumour size will be assessed using the log (ratio) of the week 12 tumour size over the baseline tumour size for each patient

    Clinical Benefit rate:

    Clinical Benefit rate is defined as number of patients with complete or partial response or stable disease maintained ≥24 weeks (as assessed by the site radiologist and/or investigator, using RECIST1.1) divided by the number of patients in the analysis. Patients without a post-baseline tumour assessment will be considered to have no clinical benefit

    Duration of Objective Response or Clinical Benefit:

    For patients with an objective response, duration of objective response is defined as the time from initial complete or partial response to disease progression or death on study from any cause (defined as death within 30 days of the last study treatment), whichever occurs first.

    For patients with a clinical benefit (objective response or stable disease maintained ≥24 weeks), duration of clinical benefit is defined as the time from randomisation to disease progression or death on study from any cause (defined as death within 30 days of the last study treatment), whichever occurs first

    Overall Survival:

    Overall survival is defined as the time from randomisation to death from any cause.

    Proportion of patients without progressive disease at 12 and 24 weeks:

    The proportion of patients without progressive disease at 12 and 24 weeks, respectively, is defined as the percentage of patients with a 12 or 24 week visit response of CR, PR or SD (as defined by RECIST 1.1) with no evidence of previous progression
    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) 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 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.8.2.4Number of treatment arms in the trial2
    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 concerned22
    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 No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    For the purposes of Clinical Trial Authorisation (CTA) under the European Union Directive 2001/20/EC, the study is deemed to have ended 30 days after the last patient receives the last dose of the investigational medicinal product (IMP). For all other purposes, the study end date is deemed to be the date of last data capture. More specifically, end of recruitment is deemed to be when 111 patients have progressed and/or have died.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days2
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days2
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 90
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state140
    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)
    Patients will be treated until disease progression, treatment-limiting toxicity or death due to any cause, elective...
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-04-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-04-11
    P. End of Trial
    P.End of Trial StatusOngoing
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