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    Summary
    EudraCT Number:2013-000293-29
    Sponsor's Protocol Code Number:ICR-CTSU/2012/10038
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2013-11-27
    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 ConcernedUK - MHRA
    A.2EudraCT number2013-000293-29
    A.3Full title of the trial
    A prospective, multi-centre, open label, non-randomised two stage phase II clinical trial evaluating the efficacy of abiraterone in patients with epithelial ovarian (including fallopian tube and primary peritoneal) cancer.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Abiraterone treatment for patients with relapsed ovarian cancer.
    A.3.2Name or abbreviated title of the trial where available
    CORAL: Cancer of the OvaRy Abiraterone triaL
    A.4.1Sponsor's protocol code numberICR-CTSU/2012/10038
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN63407050
    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 SponsorThe Royal Marsden NHS Foundation 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 supportJanssen-Cilag Ltd.
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationThe Institute of Cancer Research
    B.5.2Functional name of contact pointSophie Perry, Senior Trials Manager
    B.5.3 Address:
    B.5.3.1Street Address15 Cotswold Road
    B.5.3.2Town/ citySutton
    B.5.3.3Post codeSM2 5NG
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number02087224101
    B.5.6E-mailcoral-icrctsu@icr.ac.uk
    B.Sponsor: 2
    B.1.1Name of SponsorThe Institute of Cancer Research
    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 supportJanssen-Cilag Ltd.
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationThe Institute of Cancer Research
    B.5.2Functional name of contact pointSophie Perry, Senior Trials Manager
    B.5.3 Address:
    B.5.3.1Street Address15 Cotswold Road
    B.5.3.2Town/ citySutton
    B.5.3.3Post codeSM2 5NG
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number02087224101
    B.5.6E-mailcoral-icrctsu@icr.ac.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 Zytiga
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameAbiraterone acetate
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAbiraterone
    D.3.9.1CAS number 154229-18-2
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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) 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 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
    Epithelial ovarian cancer (including fallopian tube and primary peritoneal)
    E.1.1.1Medical condition in easily understood language
    Cancer of the ovary
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10061328
    E.1.2Term Ovarian epithelial cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10016180
    E.1.2Term Fallopian tube cancer
    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
    The primary objective of this study is to determine whether abiraterone has clinical activity (objective response rate assessed by imaging and/or CA125 tumour marker changes in the blood) in patients with epithelial ovarian cancer (EOC) that has relapsed within 12 months of last treatment.
    E.2.2Secondary objectives of the trial
    The secondary objectives are:
    1) To evaluate the objective response rate (i.e. the proportion of patients with complete or partial response at 12 weeks) using RECIST criteria.
    2) To evaluate objective response rate (i.e. the proportion of patients with complete or partial response at 12 weeks) using GCIG criteria (CA125 tumour marker).
    3) To evaluate the proportion of patients with complete or partial response or stable disease at 12 weeks as defined by RECIST/GCIG criteria (the clinical benefit rate).
    4) To evaluate the Progression Free Survival. This will be measured from the date of trial registration until first date of either death or confirmed progressive disease according to RECIST/GCIG criteria.
    5) To evaluate the proportion of study participants alive and progression free at 6 months (six month progression free survival).
    6) To evaluate the Time to Progression. This will be measured from the date of trial registration until the date of confirmed progressive d
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Patients must have histologically or cytologically confirmed epithelial ovarian, fallopian tube (FT) or primary peritoneal (PP) cancer and have progressed (radiological or CA125 criteria) within 12 months of last systemic anti-cancer therapy
    2) Life expectancy of at least 12 weeks
    3) Post-menopausal defined as:
    • Aged ≥ 18 years having had bilateral salpingo-oophorectomy (BSO)
    • Aged ≥ 45 years with intact uterus and amenorrhoeic for at least 12 months
    • FSH >40 U/L in patients who have had a hysterectomy and ovaries are intact (i.e. not had bilateral oophorectomy)
    Documentary evidence is required for patients who have undergone irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy
    4) ECOG performance status of 0-2
    5) Patients must not have had prior hormone therapy (e.g. tamoxifen, aromatase inhibitor, progestogens, anti-androgens)
    6) Patients will have received at least one line of prior platinum-based chemotherapy
    7) Measurable or evaluable disease (if not measurable by RECIST v1.1 criteria, patients must be evaluable by GCIG CA125 criteria)
    8) Archival tumour tissue (FFPE or 8-10 unstained slides) must be available. Otherwise, a biopsy must be carried out to obtain sufficient tissue for histological assessment
    9) Haematological and biochemical indices within acceptable ranges (as specified in the protocol)
    10) Aged 18 years or over
    11) Written (signed and dated) informed consent and be capable of co-operating with treatment and follow-up
    E.4Principal exclusion criteria
    1) Tumours of mucinous, clear cell, malignant mixed mesodermal (MMMT) or non-epithelial ovarian cancers (e.g. Brenner tumours, Sex-cord tumours)
    2) Radiotherapy (except for palliative reasons) or chemotherapy within the preceding three weeks (four weeks for investigational agent or within five half-lives of the investigational agent, whichever is longer)
    3) Persistent grade 2 or greater toxicities from any cause except for alopecia or grade 2 peripheral neuropathy
    4) Known leptomeningeal involvement or brain metastases
    5) Clinical and/or biochemical evidence of hyperaldosteronism or hypopituitarism
    6) Unresolved bowel obstruction
    7) Major surgery within four weeks prior to commencement of trial treatment
    8) Treatment with warfarin. Patients on warfarin for DVT/PE can be converted to LMWH at least one week prior to commencement of trial treatment
    9) At high medical risk because of non-malignant systemic disease including active uncontrolled infection
    10) Known to be serologically positive for hepatitis B and/or hepatitis C
    11) Active or uncontrolled autoimmune disease that may require corticosteroid therapy
    12) History of clinically significant heart disease, e.g. myocardial infarction or arterial thrombotic event within six months, severe or unstable angina, or New York Heart Association Class III or IV heart disease
    13) Systolic blood pressure >160 mm Hg and diastolic blood pressure >95 mm Hg documented on at least two different occasions
    [Note: Hypertension controlled by antihypertensive therapy is permitted].
    14) Any other active malignancy requiring treatment
    15) Patients for whom treatment with prednisone or prednisolone is contraindicated
    16) Patients participating in or planning to participate in another interventional clinical trial. Participation in an observational trial is acceptable
    17) Any other condition which, in the Investigator’s opinion, would not make the patient a good candidate for the clinical trial.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is to determine the objective response rate according to combined RECIST/GCIG criteria at 12 weeks after the start of treatment.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoint will assessed 12 weeks from the start of treatment.

    A formal interim analysis will be conducted after the first 26 patients have been on study for at least 12 weeks.
    E.5.2Secondary end point(s)
    The secondary endpoints are:
    • The proportion of patients with objective response according to RECIST
    • The proportion of patients with objective response according to GCIG (CA125)
    • Clinical benefit rate according to RECIST/GCIG criteria at 12 weeks
    • Progression Free Survival (PFS)
    • 6-month PFS
    • Time to Progression (TTP)
    • Overall survival (OS)
    • Toxicity according to CTCAE version 4.0
    E.5.2.1Timepoint(s) of evaluation of this end point
    Patients will continue on trial treatment until disease progression and will be followed up until 28 days (+/- 2 days) following the last administration of abiraterone. Patients will then be followed up for survival status every three months.

    The IDMC will meet regularly (every 3-6 months) to monitor the progress of the trial andd assess safety.
    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 Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    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 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 concerned3
    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 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 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 months11
    E.8.9.1In the Member State concerned days29
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days29
    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: 47
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 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 state47
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 47
    F.4.2.2In the whole clinical trial 47
    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)
    Patients will continue to receive abiraterone until they no longer derive any clinical benefit from the drug, they experience unacceptable toxicities or choose to discontinue treatment.

    There will be no arrangements for patients to receive abiraterone beyond their participation in the trial. Abiraterone is not licensed for the treatment of ovarian cancers.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation n/a
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-01-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-11-07
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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