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    Summary
    EudraCT Number:2009-017885-22
    Sponsor's Protocol Code Number:LUD2009-007
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-04-19
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2009-017885-22
    A.3Full title of the trial
    Phase II Study of ADI-PEG 20 in Patients with Relapsed Sensitive or Refractory Small Cell Lung Cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase II Study of ADI-PEG 20 in Patients with Relapsed Sensitive or Refractory Small Cell Lung Cancer
    A.3.2Name or abbreviated title of the trial where available
    Arginine Deiminase And Small Cell Lung Cancer
    A.4.1Sponsor's protocol code numberLUD2009-007
    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 SponsorLudwig Institute for Cancer Research, Ltd
    B.1.3.4CountryUnited States
    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 supportLudwig Institute for Cancer Research, Ltd.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLudwig Institute for Cancer Research, Ltd.
    B.5.2Functional name of contact pointClinical Trials Management
    B.5.3 Address:
    B.5.3.1Street Address666 Third Avenue, 28th Floor
    B.5.3.2Town/ cityNew York
    B.5.3.3Post code10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number1212450-1581
    B.5.5Fax number1212450-1535
    B.5.6E-maillpan@licr.org
    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 nameADI-PEG 20 (Pegylated Arginine Deiminase)
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPegylated Arginine Deiminase
    D.3.9.3Other descriptive namePegylated Arginine Deiminase
    D.3.9.4EV Substance CodeSUB05560MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number11.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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
    Relapsed Sensitive or Refractory Small Cell Lung Cancer
    E.1.1.1Medical condition in easily understood language
    Relapsed Sensitive or Refractory 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 14.1
    E.1.2Level PT
    E.1.2Classification code 10041070
    E.1.2Term Small cell lung cancer recurrent
    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
    Clinical Efficacy (tumor response)
    E.2.2Secondary objectives of the trial
    Safety and Tolerability
    Pharmacodynamics (plasma arginine and citrulline levels)
    Immunogenicity (ADI-PEG 20 antibodies)
    Clinical Efficacy (overall survival)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Patients must have histologically documented small cell lung cancer (SCLC).
    2) Eligible patients are assigned to one of two cohorts based on the following characteristics:
    Cohort 1: “Sensitive” disease patients who had one previous line of chemotherapy and maintained an appropriate response for 90 days or more or Cohort 2: (a) “refractory” disease patients, who had one previous line of chemotherapy and either had no response or progressed in less than 90 days after completing treatment or (b) any patient (“sensitive” or “refractory”) in need of 3rd line therapy, i.e., who completed or failed two previous lines of chemotherapy.
    3) Measurable disease using RECIST v 1.1 criteria.
    4) ASS tumor expression must be either negative or < 5% + tumor cells (by IHC analysis, for details, see Section 8.7.1 on page 45).
    5) Karnofsky performance status of 60% or more.
    6) Laboratory parameters for vital functions should be in the normal range. Laboratory abnormalities that are not clinically significant are generally permitted, except for the following laboratory parameters, which must be within the ranges specified (see protocol)
    7) Age ≥ 18 years.
    8) Able and willing to give valid written informed consent.
    E.4Principal exclusion criteria
    1) Subjects previously treated with ADI-PEG 20.
    2) Known allergy to pegylated products.
    3) History of uncontrolled seizure.
    4) Serious illnesses, e.g. serious infections requiring antibiotics, bleeding disorders, or any condition that in the opinion of the Investigator would interfere with the ability of the patient to fulfill the study requirements.
    5) Metastatic disease to the central nervous system, unless treated and stable.
    6) Known immunodeficiency or HIV positivity.
    7) Participation in any other clinical trial involving another investigational agent within 3 weeks prior to first dosing of study agent.
    8) Any other malignancy that requires concomitant therapy restricted according to Section 5.3.
    9)
    Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.
    10) Lack of availability for clinical follow-up assessment.
    11) Pregnancy or breast feeding.
    12) Refusal or inability to use effective means of contraception for men and women of childbearing potential for the duration of the study.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint for clinical efficacy is the tumor response defined as CR or PR, assessed in accordance with the established RECIST 1.1 methods and criteria (52)
    E.5.1.1Timepoint(s) of evaluation of this end point
    every 4 to 8 weeks
    E.5.2Secondary end point(s)
    Subjects who received at least one dose of ADI-PEG 20, as well as, baseline and at least one post-baseline imunogenicity assessment, will be included in this analysis. In order to investigate patterns in the levels of anti-ADI-PEG 20 antibody over time, mixed models methods or (if the limited sample size does not render this analysis feasible) repeated measures Anova method will be used. Overall survival (OS) will be measured from the initial date of treatment to the recorded date of death.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Peripheral blood ADI-PEG 20 antibodies will be determined weekly in Cycle 1-2 and every 4 weeks in Cycle 3-4. ELISA assays will be performed by Polaris Pharmaceuticals, Inc. and St Bartholomew's Hospital. The outcome will be measured on a continuous scale
    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 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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA3
    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
    Belgium
    Germany
    Taiwan
    United Kingdom
    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
    The end of the trial is defined as last patient last visit.
    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 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 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: 24
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 42
    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)
    There is no automatic provison of ADI-PEG 20 for patients at the end of the study. If patients benefit from ADI-PEG 20 then future treatment decisions that include this drug, will be at the discretion of the investigator in collaboration with Polaris Pharma (who are supplying the drug for use in this study).
    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 Decision2012-04-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-05-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-06-24
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