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    Summary
    EudraCT Number:2010-023755-28
    Sponsor's Protocol Code Number:DOXO
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2010-12-01
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2010-023755-28
    A.3Full title of the trial
    Use of doxorubicin liposomiale not peghilata (MYOCET) as second-line chemotherapy in epithelial ovarian carcinoma: Carboplatin + Myocet in patients Platinum sensitive or Myocet as single agent in patients Platinum resistant
    A.3.2Name or abbreviated title of the trial where available
    DOXO
    A.4.1Sponsor's protocol code numberDOXO
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberND
    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 SponsorUNIVERSITA` CAMPUS BIOMEDICO
    B.1.3.4CountryItaly
    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 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 Yes
    D.2.1.1.1Trade name MYOCET
    D.2.1.1.2Name of the Marketing Authorisation holderCEPHALON Srl
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNDoxorubicin
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    epithelial ovarian carcinoma recidivist
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10061328
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluate the effectiveness of Myocet as second-line drug, in association with Carboplatin in patients Platinum sensitive suffering from recidivism to disease. Evaluate the effectiveness of single drug Myocet as second-line in patients platinum resistant with relapsed disease.
    E.2.2Secondary objectives of the trial
    Assess the degree of toxicity of Myocet in terms of quality of life in patients with relapsed epithelial ovarian carcinoma.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients suffering from recidivism of epithelial ovarian carcinoma, confirmed histologically, who had disease progression at least 6 months after the end of the first-line therapy with Platinum in single regime in combination.
    2. all patients must have measurable disease or assessed. For measurable disease is defined as an injury that can be evaluated in clinical inspection or through diagnostic imaging ... For disease assessed means biopsy performed during surgery of second look, positive for neoplasia, despite ongoing intervention and through diagnostic imaging have not been observed occurrence of the disease, moreover with a CA125 negative. .
    3. Patients with ECOG Performance status (Oken MM, 1982) ≤ 2
    4. patients were hospitalized recently for complications from surgery or chemotherapy. In particular, the patient should not have infectious events in progress. If the progression has occurred in the course of previous chemotherapy, waiting for recruitment in the Protocol must be at least 4 weeks.
    5. previous Therapy:
    -Patients must have made a previous chemotherapy regime containing Carboplatin, cisplatin or other drug made of Platinum.
    -The patient must have previously signed up at least one chemotherapy regimen.
    6. the patient shall have suitable values:
    Marrow: WBC Features greater than or equal to 3,000/ul. Platelets are greater than or equal to 100, 000/ul. Granulocytes greater than or equal to 1,500/ul.
    Kidney function: creatinine less than or equal to 1.5 mg/dl: hepatic Bilirubin, SGOT and SGPT less than or equal to 1.5 times the norm. Alkaline phosphatase less than or equal to 2.5 the norm.
    Ventricular ejection fraction (LVEF) 50% in echocardiography.
    7. Patients who signed informed consent.
    8. patients who respond to parametric described in section 7.0.
    9. having Patients over the age of 18 years.
    10. patients with negative pregnancy test.
    11. patients with a life expectancy of more than 12 months
    E.4Principal exclusion criteria
    1. Platinum-resistant Patients, or patients who have recidivato within 6 months of the deadline by terpia platinum based on even during therapy.
    1b. Platinum-sensitive Patients.
    2. patients who have tumors gynecological not concurrent.
    3. Patients suffering from cancer of Brenner or borderline ovarian cancer.
    4. Patients who have not previously received any type of chemotherapy ...
    5. Patients who have previously received a cumulative dose of Doxorubicin > 350 mg/m2 and/or Epirubicin > 540 mg/m2.
    6. patients who have history of allergy to anthracycline and/or eggs ...
    7. Patients suffering from cardiovascular disease.
    8. Patients with Hemoglobin < 9 g/dl; WBCs < 1500/l; Platelets < 100,000//l; Creatinine > 1.5 mg/dl; SGOT, SGPT > 1.5 5times higher than normal.
    9. Patients affettti from serious illnesses for which the administration of chemotherapy would expose the patient at risk too high.
    10. patients who refused to sign the consent form.
    E.5 End points
    E.5.1Primary end point(s)
    Complete response (CR) represents the disappearance of macroscopic evidence of the disease for at least four weeks.

    Partial Response (PR) represents a reduction of at least 50% in the product obtained by measurement of each lesion, for at least four weeks.

    Progression of the disease represents an increase of at least 50% of the proceeds of each lesion documented within two months after its inclusion in the study or the appearance of each new lesion within eight weeks from inclusion in the study Stable Disease (SD) represents all conditions not included in previous policy Survival (Overall Survival) represents life expectancy observed since the beginning of treatment at death or on the date of last contact.

    Progression-free survival (Progression Free Survival) is the period from inclusion in the study until disease progression or on the date of last contact.

    Subjective, parameters that include performance status, specific symptoms and side effects, are evaluated to standard NCICT criteria (see Appendix I and II).
    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 No
    E.6.4Safety No
    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 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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 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 years3
    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 years3
    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.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2010-12-01. Yes
    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 state30
    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 Decision2008-08-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-07-15
    P. End of Trial
    P.End of Trial StatusOngoing
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