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    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2012-002447-14
    Sponsor's Protocol Code Number:TV1011-LC-303
    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:2012-10-17
    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 number2012-002447-14
    A.3Full title of the trial
    A Multinational, Randomized, Open-Label Phase III Study of Custirsen (TV-1011/OGX-011) In Combination With Docetaxel Versus Docetaxel As A Second-Line Treatment In Patients With Advanced or Metastatic (Stage IV) Non-Small Cell Lung Cancer
    Nemzetközi, randomizált, nyílt, III. fázisú vizsgálat a második vonalbeli kezelésként adott, docetaxellel kombinált kusztirszen (TV-1011/OGX-011) és az önmagában adott docetaxel összehasonlítására, előrehaladott vagy áttétes (IV. stádiumú), nem kissejtes tüdőrákban szenvedő betegeknél
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to find out if being treated with docetaxel and custirsen (new experimental drug) can increase survival in patients with advanced or metastatic non-small cell lung cancer, compared to the treatment with docetaxel alone. The patients must have received one prior line of platinum-based systemic anticancer therapy.
    A.3.2Name or abbreviated title of the trial where available
    ENSPIRIT
    A.4.1Sponsor's protocol code numberTV1011-LC-303
    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 SponsorOncoGenex Technologies Inc
    B.1.3.4CountryCanada
    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 supportOncoGenex Technologies Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOncoGenex Technologies Inc
    B.5.2Functional name of contact pointCarol Bailey
    B.5.3 Address:
    B.5.3.1Street Address19820 North Creek Parkway Suite 201
    B.5.3.2Town/ cityBothwell, WA
    B.5.3.3Post code98011
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1425686 1533
    B.5.5Fax number+1425686 1600
    B.5.6E-mailcbailey@oncogenex.com
    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 nameCustirsen 20mg/ml concentrate for solution for infusion
    D.3.2Product code OGX-011, TV-011
    D.3.4Pharmaceutical form Concentrate for solution for 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 INNcustirsen
    D.3.9.1CAS number 685922-56-9
    D.3.9.2Current sponsor codeOGX-011, TV-011
    D.3.9.3Other descriptive nameCustirsen 20mg/ml concentrate for solution for infusion
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 Yes
    D.3.11.13.1Other medicinal product typeantisense oligonucleotide
    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 stage IV
    E.1.1.1Medical condition in easily understood language
    Metastatic Non-Small Cell Lung Cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10029522
    E.1.2Term Non-small cell lung cancer stage IV
    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 evaluate if the combination regimen of custirsen and docetaxel improves the Overall Survival (OS) of patients with advanced or metastatic (Stage IV) NSCLC who have received one prior line of platinum-based systemic anticancer therapy.
    E.2.2Secondary objectives of the trial
    Efficacy:
    1.To compare Progression Free Survival (PFS) between patients receiving docetaxel with or without custirsen.
    2.To compare Objective Response Rate (ORR) between patients receiving docetaxel with or without custirsen.
    3.To compare Duration of Objective Response between patients receiving docetaxel with or without custirsen
    4.To compare Disease Control Rate (DCR) between patients receiving docetaxel with or without custirsen
    5.To compare Duration of Disease Control (DC), between patients receiving docetaxel with or without custirsen.

    Safety:
    To assess the safety profile of custirsen in combination with docetaxel.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Patients must have a histologically or cytologically confirmed, unresectable, advanced or metastatic (Stage IV per American Joint Committee on Cancer 7th edition of tumor, nodes and metastases classification of malignant tumors [TNM] staging) NSCLC
    2.Males or females ≥ 18 years of age at screening.
    3.Life expectancy of > 12 weeks from screening, according to the Investigator's assessment.
    4.Patients must have received one prior line of platinum-based systemic anticancer therapy for advanced (stage IIIB) or metastatic (stage IV) NSCLC. Prior maintenance therapy is allowed and will be considered as the same line of therapy when continued at the end of a treatment regimen. (Note: prior platinum-based therapy in the neoadjuvant or adjuvant setting for early-stage disease is allowed.)
    5.Patients must have documented radiological disease progression either during or after the first-line therapy.
    6.Patients must have at least one measurable lesion per RECIST 1.1 criteria.
    7.ECOG PS of 0 or 1 at screening.
    8.Have adequate bone marrow, renal and liver functions at screening as defined below:
    -Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
    -Platelet count ≥ 100 x 109/L
    -Hemoglobin ≥ 9 g/dL
    -Serum creatinine ≤ 1.5 x upper limit of normal (ULN)
    -Total Bilirubin≤1.0 x ULN (unless elevated secondary to benign conditions such as Gilbert’s disease)
    -Aspartate transaminase (AST) and alanine transaminase (ALT)≤1.5 x ULN
    9.Resolution of any toxic effects of prior therapy to Grade ≤1 according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0 (exception of alopecia and ≤ Grade 2 peripheral neuropathy).
    10.Females of child-bearing potential must have negative serum pregnancy test within 72 hours before randomization.
    11.Women of child-bearing potential will practice a highly effective method of birth control during and for 3 months after the chemotherapy/custirsen last dose. Men of reproductive potential who are not surgically sterile must agree to abstain from sexual activity or use medically accepted and highly effective method of contraception during and for 6 months after the chemotherapy/custirsen last dose.
    12.Patients must be willing and able to give written informed consent prior to any protocol-specific procedures being performed and comply with the protocol requirements for the duration of the study
    E.4Principal exclusion criteria
    1.Patients treated with any systemic anti-cancer therapy for NSCLC within 21 days prior to randomization (6 weeks for bevacizumab).
    2.Radiotherapy ≤ 2 weeks prior to randomization. Patients must have recovered from all radiotherapy-related toxicities.
    3.Major surgical procedure within 4 weeks prior to randomization. Patient must have recovered from all surgery-related complications.
    4.Patients with known central nervous system (CNS) metastases (Patients with any clinical signs of CNS metastases must have a CT or MRI of the brain to rule out CNS metastases in order to be eligible for participation in the study. Patients who have had brain metastases treated with radiotherapy or surgically removed with no residual disease confirmed by imaging should be clinically stable and off corticosteroid treatment at least 3 weeks prior to randomization).
    5.Patients with current diagnosis or a history of another active primary malignancy (except in situ carcinoma of the cervix, adequately treated non-melanomatous skin cancers, clinically localized prostate cancer, superficial bladder cancer or other malignancy treated at least 5 years previously with no evidence of recurrence).
    6.Severe or unstable medical conditions such as heart failure, ischemic heart disease, uncontrolled hypertension, uncontrolled diabetes mellitus, psychiatric condition, as well as an ongoing cardiac arrhythmia requiring medication (≥ Grade 2, according to NCI CTCAE v4.0) or any other significant or unstable concurrent medical illness that in the opinion of the Investigator would preclude protocol therapy.
    7.A history of events such as myocardial infarction, cerebrovascular accident (CVA) or acute hepatitis within 3 months of randomization or treatment of a major active infection within one month of randomization, or any other significant event that in the opinion of the Investigator would preclude protocol therapy.
    8.Planned concomitant participation in another clinical trial of an experimental agent, vaccine, or device. Concomitant participation in observational studies is acceptable.
    9.Female patients who are breastfeeding.
    10.Patients previously treated with docetaxel for NSCLC or with known severe hypersensitivity to taxane therapies. (Note: Prior use of paclitaxel is allowed.)
    11.Patients with known and documented EGFR mutation who have not received an EGFR inhibitor.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint and variable for the study is OS, defined as the time from date of randomization to the date of death from any cause.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Date of death
    E.5.2Secondary end point(s)
    -Progression Free Survival (PFS)
    -Objective Response Rate (ORR)
    -Duration of Objective Response
    -Disease Control Rate (DCR)
    -Duration of Disease Control
    E.5.2.1Timepoint(s) of evaluation of this end point
    -PFS, defined as the time from the date of randomization to the first objective documented progression per RECISTv1.1 or death due to any cause,whichever occurs first.
    -OR is defined as achieving a best overall response of CR or PR,as defined using RECISTv1.1.
    -Duration of OR is defined as time from first occurrence of CR or PR (whichever is first recorded) until date of the first documented disease progression or death, whichever occurs first.
    -DC is defined as achieving a best overall response of CR, PR or SD.
    -Duration of DC is defined as the time from randomization to the date of the first documented disease progression or death, 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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    To compare the arms with respect to Quality of Life (QoL) parameters Functional Assessment of Cancer Therapy – Lung (FACT-L) and Euro Quality of Life – 5D (EQ-5D)
    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 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 Yes
    E.8.2.3.1Comparator description
    Docetaxel 75 mg/m2 IV on Day 1 of every 21-day cycle
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA60
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Germany
    Hungary
    Israel
    Italy
    Korea, Republic of
    New Zealand
    Poland
    Russian Federation
    Singapore
    Spain
    Taiwan
    Thailand
    Ukraine
    United States
    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
    2 formal interim analyses are planned for stopping the trial early based on inadequate evidence of clin. benefit or futility:see stop criteria pg11-protocol.If study continues final efficacy analysis is planned after 850death events.All pts who discont.study treatm. will be followed to collect further anticancer treatment and survival information until death,loss to follow-up,withdrawal of consent,or up to 12months after end of treatment visit for last patient on the study,whichever comes first.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    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 years4
    E.8.9.2In all countries concerned by the trial months10
    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.1.2.1Number of subjects for this age range: 280
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 420
    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 state127
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 488
    F.4.2.2In the whole clinical trial 660
    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)
    All patients who discontinued study treatment will be followed to
    collect further anticancer treatment and survival information until death, loss to
    follow-up, withdrawal of consent, or up to 12 months after the end of treatment
    visit for the last patient on the study, whichever comes first. Patients who are removed from study treatment for any reason other than disease progression or
    death will be followed for documented radiological disease progression.
    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 Decision2012-12-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-12-04
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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