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    Summary
    EudraCT Number:2004-005181-20
    Sponsor's Protocol Code Number:CEPO906A2303
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-03-20
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2004-005181-20
    A.3Full title of the trial
    A randomized, parallel group, open-label, active controlled, multicenter Phase III trial of Patupilone (EPO906) versus pegylated liposomal doxorubicin (Doxil/Caelyx) in taxane/platinum refractory/resistant patients with recurrent epithelial ovarian, primary fallopian or primary peritoneal cancer
    A.4.1Sponsor's protocol code numberCEPO906A2303
    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 SponsorNovartis Pharma Services AG
    B.1.3.4CountrySwitzerland
    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 Yes
    D.2.5.1Orphan drug designation number EU/3/02/098
    D.3 Description of the IMP
    D.3.1Product namepatupilone
    D.3.2Product code EPO906
    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 INNpatupilone
    D.3.9.1CAS number 152044-54-7
    D.3.9.2Current sponsor codeEPO906
    D.3.9.3Other descriptive nameEpothilone B
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10mg/4ml
    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 Yes
    D.3.11.13.1Other medicinal product typehighly purified fermentation product
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Caelyx
    D.2.1.1.2Name of the Marketing Authorisation holderSchering Plough Europe
    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 nameCaelyx
    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 hydrochloride
    D.3.9.3Other descriptive nameDoxorubicin hydrochloride (pegylated liposomal)
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2mg/ml
    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) 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
    Approximately 75% of women with ovarian cancer present advanced disease. Survival is highly dependent on the stage of disease at the initiation of treatment. Recommended first-line therapy is a combination of platinum drug and paclitaxel. Patients who progress during primary therapy or within 6 months after are considered platinum refractory/resistant. The prognosis of patients with resistant / refractory ovarian cancer is uniformly poor with median overall survival ranging from 35 – 41 weeks
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To show superiority of patupilone in overall survival compared to pegylated liposomal doxorubicin (Doxil®/Caelyx®) in taxane/platinum refractory/resistant patients with recurrent epithelial ovarian, primary fallopian or primary peritoneal cancer.
    E.2.2Secondary objectives of the trial
    To evaluate:
    •progression free survival
    •best overall response rate (RECIST criteria)
    •CA-125 response for patients with evaluable disease as defined by Rustin criteria
    •duration of best overall response
    •time to progression
    •best overall response
    •the safety and tolerability of patupilone administered in this dose, regimen and this pt population
    •detailed cardiac safety surveillance of a single dose of patupilone and pegylated liposomal doxorubicin on QT interval, heart rate and cardiac conduction intervals in a limited number patients
    •To conduct PK-PD analysis
    •To perform pharmacogenomic assessments to examine whether expression levels of beta-tubulin isoforms in tumor cells correlate with resistance to patupilone.
    •To evaluate patient-reported symptoms and quality of life (QoL) of patients using the FACT-O
    •To evaluate change in disease symptoms, as assessed by the FOSI
    To summarize the overall response by both RECIST and CA-125 as composite end-point
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    CARDIAC SAFETY (optional - included in the core protocol and post-text supplement 2)
    TITLE: A parallel group study in a randomized open label multicenter Phase III trial of Patupilone (EPO906) versus pegylated liposomal doxorubicin (Doxil®/Caelyx®) to evaluate cardiac safety in taxane/platinum refractory/resistant patients with recurrent epithelial ovarian, primary fallopian or primary peritoneal cancer
    POPULATION: a subgroup of 130 patients patients from each treatment group) who agree to enroll in the sub-study (separate informed consent)
    OBJECTIVES:
    · to perform cardiac safety surveillance of the effects of a single dose of patupilone versus a single dose of pegylated liposomal doxorubicin on QT interval (corrected and uncorrected), heart rate (HR), and cardiac conduction intervals (QRS, RR, and PR) in taxane/platinum refractory/resistant patients with recurrent epithelial ovarian, primary fallopian or primary peritoneal cancer.


    EXPLORATORY BIOMARKER (optional - included in the core protocol and post-text supplement 6)
    TITLE: no separate title (included in the core protocol and post-text supplement 6)
    POPULATION: patients who agree to enroll in this exploratory sub-study (separate informed consent)
    OBJECTIVES:
    · To examine whether individual genetic variation in genes relating to drug metabolism, ovarian, primary fallopian, or primary peritoneal cancer, and the drug target pathway confer differential response to Patupilone.
    · To examine gene expression patterns, proteins, and metabolites of blood and tumor tissue that are associated with treatment response to Patupilone, or that possibly correlate with the severity or progression of ovarian, primary fallopian, or primary peritoneal cancer.
    E.3Principal inclusion criteria
    - Histologically confirmed diagnosis of epithelial ovarian, primary fallopian or primary peritoneal cancer.
    - Resistant / refractory to prior intravenous or intraperitoneal platinum-based chemotherapy (up to three prior regimens)
    - Taxane/platinum refractory/resistant patients must present with either measurable (by RECIST criteria) or non-measurable (based on both imaging and CA-125 evaluations) progressive disease
    - Left ventricular ejection fraction (LVEF) >/= 50% by MUGA or 2-D echocardiography
    - Age > 18 years.
    - WHO performance status of 0, 1, or 2.
    - Negative serum pregnancy test at screening (Not applicable to patients who are surgically sterilized or who are postmenopausal).
    - Sexually active female patients must either be surgically sterilized, post-menopausal (no regular menstrual bleeding for at least 2 years) or practicing an acceptable form of birth control (i.e. double barrier method – intrauterine device plus condom, spermicidal gel plus condom)
    E.4Principal exclusion criteria
    - Patients with CA-125-only disease
    - Unresolved bowel obstruction
    - Prior administration of epothilones, anthracyclines and/or pegylated liposomal doxorubicin
    - Date of first study treatment would be more than 30 days past the screening CT scan (ScreeningCT scan must be performed within 6 months from last dose of platinum based chemotherapy confirming disease progression
    - Any peripheral neuropathy > CTC grade 1
    - Unresolved diarrhea of any grade within last 7 days prior to start of treatment.
    - Presenting with symptomatic brain metastasis and/or leptomeningeal involvement
    - Within 3 weeks of receiving any prior chemotherapy or radiotherapy or who are planning to receive either while participating in the study
    - Severe cardiac insufficiency (NYHA III or IV), with uncontrolled and/or unstable cardiac or coronary artery disease
    - History of another malignancy within 5 years prior to study entry, except curatively treated non-melanotic skin cancer or cervical cancer in situ
    - Receiving hematopoietic growth factors (except erythropoietin)
    - Concomitant administration of Coumadin® or other agents containing warfarin with the exception of low dose Coumadin® (1 mg or less daily) administered prophylactically for maintenance of in-dwelling lines or ports.(Wash-out period from therapeutic dose of Coumadin should be ≥ 7 days)
    - Concomitant administration of any drug/agent known to cause, or increase the severity of, diarrhea
    - Concomitant administration of any drug/agent known to interact negatively with doxorubicin or pegylated liposomal doxorubicin
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of this study is overall survival (OS).
    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 Yes
    E.6.12Pharmacoeconomic Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA70
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    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 months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months9
    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) Yes
    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 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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 400
    F.4.2.2In the whole clinical trial 810
    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 Decision2006-04-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-03-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-02-26
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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