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    Summary
    EudraCT Number:2010-022757-42
    Sponsor's Protocol Code Number:IMM-101-002
    National Competent Authority:Ireland - HPRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-04-10
    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 ConcernedIreland - HPRA
    A.2EudraCT number2010-022757-42
    A.3Full title of the trial
    A Randomised, Open-Label, Proof-of-Concept, Phase II Trial Comparing Gemcitabine with and without IMM-101 in Advanced Pancreatic Cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase II Study Comparing the effects of Gemcitabine with and without IMM-101 in Advanced Pancreatic Cancer
    A.4.1Sponsor's protocol code numberIMM-101-002
    A.5.4Other Identifiers
    Name:IMM-101-002 V1.0 inc amendment 1 and 2Number:Final Version 1.0 including Amendment 1 and 2
    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 SponsorImmodulon 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 supportImmodulon Therapeutics Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationImmodulon Therapeutics Ltd
    B.5.2Functional name of contact pointClinical Trials Co-ordinator
    B.5.3 Address:
    B.5.3.1Street AddressThe London Clinic Cancer Centre
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeW1G 6JA
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number00 440203 219 3568
    B.5.5Fax number00 440207 224 280
    B.5.6E-mailIlda@immodulon.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.2.1.1.1Trade name None
    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 nameIMM-101
    D.3.2Product code Heat-killed whole cell Mycobaterium obuense
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntradermal use
    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) Yes
    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 typeHeat-killed whole cell mycobacterium obusense
    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
    Advanced pancreatic cancer
    The overall objective of this clinical study is to evaluate a potential synergy between gemcitabine and IMM-101 and any beneficial effect this may have on safety and tolerability, QoL, clinical signs and symptoms of disease, disease outcome and selected markers of tumour burden and immunological status in patients with inoperable, locally advanced or metastatic pancreatic cancer.
    E.1.1.1Medical condition in easily understood language
    Cancer of the pancreas
    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 LLT
    E.1.2Classification code 10033606
    E.1.2Term Pancreatic cancer non-resectable
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    No clinically relevant deleterious effect of IMM-101 on safety and tolerability profiles as judged by:
    • Local and systemic toxicities.
    • Number, type and degree of toxicities as measured by the NCI CTCAE v4.0.
    • QoL (EORTC QLQ-C30 supplemented with EORTC QLQ-PAN26).
    E.2.2Secondary objectives of the trial
    A clinically relevant improvement in one or more markers of disease status and progression:
    • Overall survival (OS).
    • Progression-free survival (PFS).
    • Overall response rate (ORR).
    • Reduction in metastatic disease
    • Circulating levels of carbohydrate antigen 19.9 (CA19.9).
    • Circulating levels of carcinoembryonic antigen (CEA).
    • Nutritional status (weight, appetite, serum albumin).
    • Pain control and analgesic use.

    Exploratory endpoints may include:
    •A change in levels of circulating tumour cells consistent with a reduction or stabilisation of tumour burden.
    •A change in one or more markers of immune status based on cellular involvement or cytokine/immune mediator production.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Histologically and/or cytologically confirmed inoperable ductal adenocarcinoma of the pancreas, including the mucinous variant. This will include locally advanced and metastatic disease (stage III/IV).

    Presence of measurable lesions in at least one site which have not been previously irradiated (bone lesions, ascites and pleural effusions are not considered as measurable), described as any of the following:
    • Any primary tumour with at least bi-dimensionally measurable disease.
    • a) Palpable lymph nodes, b) Deep seated lymph nodes.
    • Liver metastases measurable by computerised tomography (CT) scan.
    • Deep seated soft tissue lesions measurable by CT scan.
    WHO performance status of 0-2.
    Serum creatinine <140 µmol/L.
    White blood cell (WBC) count, including differential counts within the normal range or, if outside the normal range, considered by the
    investigator to be not clinically significant.
    Life expectancy, in the opinion of the Investigator, of >3 months from randomisation.
    Provide written informed consent to participate as shown by a signature and date on the patient's informed consent form (ICF)

    E.4Principal exclusion criteria
    Patients will be ineligible if one or more of the following statements are applicable:
    Patient has acinar cell carcinoma, neuroendocrine tumours, lymphomas or squamous cell carcinomas.
    Patient has severe, active uncontrolled infection requiring systemic antibiotics, antiviral or antifungal treatments.
    Patient has been on any previous chemotherapy treatment for pancreatic cancer.
    Patient is eligible for resection of the pancreatic primary tumour but has either refused the operation or is considered to be medically unfit for the operation.
    Patient has clinical or CT evidence of central nervous system (CNS) metastases.
    Patient has any previous or concurrent malignancy, except adequately treated carcinoma in situ of the cervix, basal cell carcinoma of the skin and/or non-melanoma skin cancer, or if previous malignancy was more than 5 years prior and there are no signs of recurrence.
    Patient has serum albumin < 26 g/L.
    Patient has a C-reactive protein (CRP) > 70 mg/L.
    Patient has had radiotherapy in the 6 weeks prior to screening.
    Patient has used depot corticosteroids in the 6 weeks prior to screening.
    Patient has had chronic use of any systemic corticosteroids (>10 mg per day of prednisolone or equivalent for a period of 2 weeks or more) and/or immunosuppressant drugs (such as azathioprine, tacrolimus, cyclosporin) within the 2-week period prior to the first administration of study drug.
    Female patient of child-bearing potential who is not, in the opinion of the Investigator, using an approved method of birth control (e.g. physical barrier [patient and partner], contraceptive pill or patch, spermicide and barrier, or intrauterine device [IUD]). Those patients that utilise hormonal contraceptives must have used the same method for at least three months before study dosing. Patient of non-child-bearing potential are defined as having 12 month amenorrhoea or are surgically sterile.
    Female patient who is pregnant, breast feeding or planning a pregnancy during the course of the study. A pre-treatment serum pregnancy test measuring human chorionic gonadotrophin (HCG) must be negative.
    Patient has been administered any investigational drug, vaccine or device in the 3 months prior to screening. Patient has a surgical or medical condition which, in the judgement of the Investigator, might interfere with the activity of IMM-101, or with the performance of this study.
    Patient has presence of any uncontrolled concomitant disease (e.g. unstable angina pectoris, congestive heart failure, myocardial infarction, arrhythmias, uncontrolled severe hypertension) which, in the judgement of the Investigator, might interfere with the activity of IMM-101, or with the performance of this study.
    Patient has a history of serious adverse reaction or serious hypersensitivity to any drug.
    Patient has had any previous treatment with IMM-101 or related mycobacterial immunotherapy.
    Patient is known to have a history of human immunodeficiency virus (HIV) or syphilis, current symptomatic Hepatitis B or C. Testing is not required in the absence of clinical signs and symptoms suggestive of infection with HIV.
    Patient is unable or unwilling to comply with the protocol.
    E.5 End points
    E.5.1Primary end point(s)
    No clinically relevant deleterious effect of IMM-101 on safety and tolerability profiles as judged by:

    Local and systemic toxicities.

    Number, type and degree of toxicities as measured by the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) v4.0.

    QoL (EORTC QLQ-C30 questionnaire supplemented by the pancreas cancer specific EORTC QLQ-PAN26 questionnaire).
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 6 months and 12 months treatment
    E.5.2Secondary end point(s)
    A clinically relevant improvement in one or more markers of disease status and progression:
    • Overall survival (OS).
    • Progression-free survival (PFS).
    • Overall response rate (ORR).
    • Reduction in metastatic disease.
    • Circulating levels of carbohydrate antigen 19.9 (CA19.9).
    • Circulating levels of carcinoembryonic antigen (CEA).
    • Nutritional status (weight, appetite, serum albumin).
    • Pain control and analgesic use
    E.5.2.1Timepoint(s) of evaluation of this end point
    After 6 months and 12 months 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 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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    standard of care (Gemcitabine)
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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 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
    Last patient, last visit
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    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.1.1Number 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: 60
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 80
    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)
    At the end of the 12-cycle treatment phase, all surviving patients will be offered the opportunity to enter a long-term follow-up study (under a separate protocol - still to be defined) or their oncologist can continue to treatment on a named patient basis
    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 Decision2012-08-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-10-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-01-14
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