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    The EU Clinical Trials Register currently displays   35419   clinical trials with a EudraCT protocol, of which   5814   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2007-004340-67
    Sponsor's Protocol Code Number:EG006/208
    National Competent Authority:Czech Republic - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-04-07
    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 ConcernedCzech Republic - SUKL
    A.2EudraCT number2007-004340-67
    A.3Full title of the trial
    A multi-centre, double-blind, randomised, placebo-controlled, phase IIa exploratory study of the effects of Imidapril on body weight and body composition in Non-Small Cell Lung Cancer patients with cancer cachexia.
    A.4.1Sponsor's protocol code numberEG006/208
    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 SponsorArk Therapeutics Limited
    B.1.3.4CountryUnited Kingdom
    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 nameImidapril
    D.3.2Product code EG006
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIMIDAPRIL
    D.3.9.1CAS number 89371379
    D.3.9.2Current sponsor codeEG006
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3.33
    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.IMP: 2
    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 nameImidapril
    D.3.2Product code EG006
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIMIDAPRIL
    D.3.9.1CAS number 89371379
    D.3.9.2Current sponsor codeEG006
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.67
    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 placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Cancer Cachexia in Non-small Cell Lung Cancer
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10064015
    E.1.2Term Cancer cachexia
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To explore the effects on body weight, muscle strength and body composition parameters including body cell mass (BCM) and lean body mass (LBM).
    E.2.2Secondary objectives of the trial
    - To explore the effects on health status/Quality of Life (QoL)
    - To explore the effects on appetite
    - To evaluate the safety and tolerability of oral imidapril
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients who have measurable NSCLC disease that has been histologically or cytologically proven and has been recently (≤ 18 months) diagnosed.
    2. Male or female patients ≥18 and ≤ 75 years of age.
    3. Patients with a history of unintentional and undesired weight loss within 6 months of the screening visit.
    4. BMI ≤ 27.
    5. Male and female patients must be using effective contraception if the risk of conception exists.
    6. Patients who during the 6-week flexible placebo run-in period have a documented weight loss of:
    - ≥ 1 kg in any 2 weeks, or
    - ≥ 1.5 kg in 4 weeks, or
    - ≥ 1.75 kg in 6 weeks.
    7. Patients who a) are not expected to undergo chemotherapy during the study or b) have already started a course of cycle/s of chemotherapy before the screening visit, where chemotherapy is defined as any anti tumour medication.
    8. Patients with a life expectancy of ≥ 6 months.
    9. Patients with Karnofsky Performance score of ≥ 60.
    10. Patients (or legal representative) who provide signed written informed consent.
    E.4Principal exclusion criteria
    1. Patients planning to commence chemotherapy (i.e. a course of treatment not prescribed prior to screening) after the screening visit.
    2. Patients receiving or planning to receive cranial radiotherapy after the screening visit.
    3. Patients with untreated thyrotoxicosis.
    4. Patients with a pacemaker or other internal electrical medical device.
    5. Patients receiving parenteral nutrition or enteral hyperalimentation.
    6. Patients diagnosed with a Diagnostic and Statistical Manual-classified eating disorder such as anorexia nervosa or bulimia.
    7. Patients at the screening or baseline visits with:
    - low blood pressure defined as a sitting systolic blood pressure < 100 mmHg
    - hypotension defined as grade 2 or greater according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; formerly known as the National Cancer Institute Common Toxicity Criteria [NCI-CTC]), version 3.0
    - clinical symptoms of postural hypotension or orthostatic changes in blood pressure, defined as a decrease in systolic blood pressure of > 20 mmHg or decrease in diastolic blood pressure of > 10 mmHg after shifting from a supine to sitting (with legs dependent) position.
    8. Patients at the screening visit with a history of angioneurotic oedema
    9. Patients with an active infection.
    10. Patients with ascites or generalised oedema, requiring treatment.
    11. Patients with renal disease (serum creatinine of > 2 mg/dL); or severe hepatic dysfunction (i.e., aspartate aminotransferase [AST], alanine aminotransferase [ALT], alkaline phosphatase [ALP], or bilirubin levels at toxicity grade 3 or 4 [according to the NCI CTCAE criteria, version 3.0]) at the screening visit.
    12. Patients at the screening visit with hyperkalaemia, defined as grade 3 or 4 according to the NCI CTCAE criteria, version 3.0 (> 6.0 mmol/L).
    13. Patients at the screening visit with neutrophil counts of < 1500/µL.
    14. Patients who are concomitantly receiving any of the following:
    - potassium-sparing diruetics
    - lithium
    - an anabolic regimen (including oxandralone, testosterone, or growth hormone)
    - oestrogen and progestational agents (e.g. Megastrol), unless being taken for contraception purposes
    - cyproheptadine hydrochloride, pentoxifylline, thalidomide, dronabinol (Marinol)
    - angiotensin II antagonist or ACE inhibitor, including imidapril
    - systemic steroids (other than for the treatment of chemotherapy induced nausea), or have been treated with systemic steroids for more than 21 consecutive days within the previous 3 months prior to the screening visit. [Low dose systemic steroids (equivalent to no more than 10mg prednisolone), given for a period of at least a month prior to screening, are permitted provided that their administration is stable and there is no anticipated change in use during the course of the study].
    15. Patients who were treated with any investigational drug within 30 days or within five plasma half-lives (whichever is the longer) prior to screening visit.
    16. Patients on any other clinical trial.
    17. Patients who have known hypersensitivity to ACE inhibitors.
    18. Patients who are not capable of fully understanding the study requirements or are unwilling/unable to comply with the study procedures.
    19. Patients with malignancy (unless in remission) other than NSCLC.
    20. Pregnant or lactating female patients.
    21. Patients with a medical condition that, in the opinion of the investigator, would compromise their ability to participate in the study.
    22. History of known alcohol or drug abuse.
    23. Patients who have <80% compliance during the placebo run-in phase with regards to taking their study medication.
    E.5 End points
    E.5.1Primary end point(s)
    - the rate of change and percentage change in BCM from randomisation to the end of study treatment, measured using the Quantum/STA bioimpedance analyser

    - the rate of change and percentage change of LBM from randomisation to the end of study treatment, measured by bioimpedance

    - the rate of change and percentage change in body weight using Tanita scales from randomisation to end of treatment

    - the rate of change and percentage change in muscle strength (determined by hand-grip dynamometry measurements) from randomisation to the end of study treatment
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over Yes
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Placebo (single-blind) run-in phase: 2 to 6 weeks duration
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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 Information not present in EudraCT
    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
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Non-small cell lung cancer patients where legal representatives can provide consent
    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 150
    F.4.2.2In the whole clinical trial 150
    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 Decision2008-06-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-05-07
    P. End of Trial
    P.End of Trial StatusCompleted
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