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    Summary
    EudraCT Number:2011-003950-24
    Sponsor's Protocol Code Number:EOX1.4
    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:2012-01-05
    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 number2011-003950-24
    A.3Full title of the trial
    PHASE II TRIAL OF PALLIATIVE EPIRUBICIN, OXALIPLATIN & CAPECITABINE (EOX) CHEMOTHERAPY COMBINED WITH OMEGA-3 FISH OIL INFUSION (OMEGAVEN) IN PATIENTS WITH OESOPHAGO-GASTRIC CARCINOMA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    PALLIATIVE CHEMOTHERAPY (EOX) & FISH OIL INFUSION (OMEGAVEN) IN OESOPHAGO-GASTRIC CANCER PATIENTS
    A.3.2Name or abbreviated title of the trial where available
    PALLIATIVE EOX & OMEGAVEN IN OESOPHAGO-GASTRIC CANCER PATIENTS
    A.4.1Sponsor's protocol code numberEOX1.4
    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 SponsorUniversity Hospitals of Leicester NHS Trust
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNiversity hospitals of Leicester
    B.5.2Functional name of contact pointMr Amar Eltweri
    B.5.3 Address:
    B.5.3.1Street AddressLevel 6 Balmoral Building, Leicester Infirmary Square
    B.5.3.2Town/ cityLeicester
    B.5.3.3Post codeLE1 5WW
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailamar.eltweri@uhl-tr.nhs.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 Yes
    D.2.1.1.1Trade name Omegaven
    D.2.1.1.2Name of the Marketing Authorisation holderFresenius Kabi
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameOmegaven (omega-3 fish oil)
    D.3.4Pharmaceutical form Emulsion 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 INNEicosapentaenoic acid (EPA)
    D.3.9.1CAS number 10417-94-4
    D.3.9.3Other descriptive nameTimnodonic Acid
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDocosahexaenoic Acid (D)XA
    D.3.9.1CAS number 6217-54-5
    D.3.9.3Other descriptive nameCervonic Acid
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 Yes
    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
    Unresectable oesophageal and/or gastric cancer
    E.1.1.1Medical condition in easily understood language
    Unresectable oesophagus (Gulet)and/or stomach 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
    To see whether adding intravenous ω-3 FA emulsion to standard palliative chemotherapy (EOX) improves quality of life and/or prognosis, in patients with incurable gastric or oesophageal carcinoma.
    E.2.2Secondary objectives of the trial
    • To determine the toxicity profile of the combination of omega-3 fish oil with standard EOX chemotherapy • To determine complete and partial response rates (as per RECIST v1.1 criteria) • To determine the feasibility of use of omega-3 fish oil with standard EOX chemotherapy • To collect tumour and blood samples for future translational work including investigating cytokine levels (leukotrienes B4, B5), Tumour necrosis factor-alpha, Interleukein-1, Iterleukein-2 and Interleukein-6; determining ω-3/6 ratios in cellular membranes of blood leucocytes, erythrocytes, plasma, platelets and tumour tissue • To determine quality of life, pain ratings and health status of patients using the EORTC QLQ-C30 questionnaire, brief pain inventory short form and dysphagia scores respectively • To determine the cost-effectiveness of the treatment by means of determination of NHS costs and quality of life using the EQ-5D questionnaire, enabling QALYs to be calculated
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Histologically confirmed gastric or oesophageal carcinoma (irrespective of subtype), deemed incurable as a result of standard staging investigations. • Measurable disease according to RECIST v1.1 criteria on CT within 4 weeks of study entry • WHO Performance status 0-2 • Aged >18 years • Able to give informed written consent • Life expectancy >12 weeks • Adequate hepatic and renal function documented within 7 days prior to treatment (estimated GFR>50ml/min, serum bilirubin <1.5x ULN; ALT or AST <2.5x ULN; ALP <3x ULN (in the absence of liver metastases). If liver metastases are present, serum transaminases <5x ULN are permitted.) • Adequate bone marrow function documented within 7 days (Haemoglobin ≥9g/dL, Platelets ≥100,000 cells/mm3, Neutrophil Count ≥1500 cells/mm3) • Women of childbearing age must have a negative pregnancy test (urine or serum) at commencement of treatment • Willing to use contraception if applicable • Willingness to comply with scheduled visits, treatment, laboratory test, and other aspects of the trial
    E.4Principal exclusion criteria
    • Prior radical treatment within 6 months of relapse • Prior treatment with any systemic chemotherapy for metastatic disease • Prior adjuvant radio- or chemotherapy within 4 weeks of starting the study • Patients with locally advanced disease deemed suitable for radical chemo-radiotherapy • Known hyperlipidaemic state (use of a statin permissible) • Patients with known coagulation disorders • Hypersensitivity to fish, egg protein or to any of the active substances or constituents in the lipid emulsion • Any general contra-indications to infusion therapy – pulmonary oedema, hyperhydration, decompensated cardiac insufficiency • Any unstable medical conditions – uncontrolled diabetes mellitus, acute myocardial infarction, stroke, embolic disease, metabolic acidosis, sepsis, pancreatitis • Known HIV or hepatitis B or C carrier • Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with requirements of the protocol • History of malignancy other than gastric or oesophageal cancer, with the exception of curative treatment for skin cancer (other than melanoma) or in situ breast or cervical carcinoma, or those treated with curative intent for any other cancer with no evidence of disease for 5 years • Major surgical procedure or significant traumatic injury within 4 weeks of treatment • Cerebral metastases • History of interstitial lung disease (e.g., pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on baseline chest CT scan • Known peripheral neuropathy > Grade 1 (absence of deep tendon reflexes as the sole neurological abnormality does not render the patient ineligible). • Lack of physical integrity of the upper gastro-intestinal tract, malabsorption syndrome, or inability to take oral medication (administration of capecitabine by naso-gastric or jejunostomy feeding tube is permitted).
    E.5 End points
    E.5.1Primary end point(s)
    To determine the anti-tumour activity of the combination of omega-3 fish oil in combination with standard palliative EOX chemotherapy as measured by PFS. This is the time from enrolment to any disease progression and/or death, defined according to strict radiological criteria (Response Evaluation Criteria in Solid Tumours (RECIST v 1.1). Lesions will be compared to baseline measurements to assess progression.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary end point will be at 36 weeks from the commencement of the palliative treatment, each participant will have a CT scan at this time to evaluate for any progression, which will be used to assess for the progression free survival.
    E.5.2Secondary end point(s)
    • Evaluation of toxicity, feasability and effect of fish oil infusion. • Overall survival (OS).
    E.5.2.1Timepoint(s) of evaluation of this end point
    •A safety review of toxicities will be performed after 10 and 21 patients have completed at least one cycle of chemotherapy and omega-3 fish oil treatment, If the review concludes that there is excess unacceptable toxicity then the safety committee may recommend that recruitment into the trial should cease. If the committee deem the trial safe to continue, recruitment will continue until a further 24 participants have been recruited (i.e. a total of 45 participants). •Time from enrolment to death for the overall survival.
    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 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 Yes
    E.8.1.7.1Other trial design description
    Single arm study
    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
    Historical data of expected progression of discease within 6 months
    E.8.2.4Number of treatment arms in the trial1
    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 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 regulatory requirements the end of the trial is defined as the date of the last treatment visit for the last participant undergoing protocol treatment (week 24). The treatment phase will be followed by a follow up period which will continue for 1 year after the last participant completes protocol treatment. For the purposes of the Research Ethics Committee approval, the study end date is deemed to be the date of last data capture
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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 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.1.1Number 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: 0
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 0
    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 state45
    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)
    Omega-3 fish oil supplementation will be provided in conjunction with the palliative chemotherapy. Once the chemotherapy treatment is completed, the omega-3 fish oil supplementation will stop as well. In short, both types of treatment will continue for up to 8 cycles.
    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 Decision2012-02-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-01-13
    P. End of Trial
    P.End of Trial StatusOngoing
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