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    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2006-002324-41
    Sponsor's Protocol Code Number:PH2/051
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2006-10-09
    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 number2006-002324-41
    A.3Full title of the trial
    A Cancer Research UK Randomised Multicentre Phase II Trial of the DNA-hypomethylating Agent, 5-Aza-2'-deoxycytidine(Decitabine) given intravenously in Combination with Carboplatin, versus Carboplatin alone given 4 weekly in patients with progressive, advanced Ovarian cancer.
    A.3.2Name or abbreviated title of the trial where available
    Decitabine and Carboplatin in Relapsed Ovarian Cancer
    A.4.1Sponsor's protocol code numberPH2/051
    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 SponsorCancer Research UK
    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 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 Dacogen
    D.2.1.1.2Name of the Marketing Authorisation holderMGI Pharma, Inc
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameDecitabine
    D.3.4Pharmaceutical form Powder 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 INNDECITABINE
    D.3.9.1CAS number 2353335
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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.IMP: 2
    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 Information not present in EudraCT
    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 nameCarboplatin
    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 INNCARBOPLATIN
    D.3.9.1CAS number 41575944
    D.3.9.2Current sponsor codeCarboplatin
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    Progressive, advanced ovarian cancer
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10033128
    E.1.2Term Ovarian cancer
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To estimate the response rate of the combination of decitabine and carboplatin compared to carboplatin alone in patients with progressive advanced ovarian cancer who have previously responded to platinum based chemotherapy and who have methylated hMLH1 DNA in plasma.
    E.2.2Secondary objectives of the trial
    1) To estimate the response rate of the combination of decitabine and carboplatin compared to carboplatin alone in all patients regardless of methylation status.

    2) To determine progression free survival and overall survival in patients with this drug combination, who have methylated hMLH1 DNA in plasma and in all patients.

    3) To examine the safety and tolerability of this drug combination.

    4) To determine the feasilbility of combining decitabine with carboplatin.

    5) To determine the incidence of hypersensitivity reactions to carboplatin.

    6) To study the relationship between peak plasma levels of decitabine and global CpG island specific methylation.

    7) To study the relationship between global and gene specific methylation in PMN cells and response.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Histologically or cytologically proven progressive, epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer. (Progression is defined by GCIG guidelines (RECIST criteria and/or CA-125 criteria)).

    2) Maximum of one prior line of treatment. This must have been a platinum containing regimen.

    3) A clinical response by RECIST criteria and/or CA-125 criteria to the one prior platinum containing regimen with relapse of disease at least 6 months but no greater than 12 months after completion of treatment.
    Patients who have progression of disease by CA-125 criteria alone within 6 months of the end of treatment will be eligible provided study treatment does not commence within 6 months of previous treatment.
    Patients who have progression of disease as defined by GCIG guidelines within 12 months after completion of previous treatment will be eligible provided that treatment on study commences within 14 months.

    4) Measurable disease by RECIST criteria and/or by GCIG CA-125 criteria
    • Measurable Disease. Measurable lesions are defined as those that can be accurately measured in at least one dimension (longest diameter to be recorded) as > 20 mm with conventional techniques (physical examination, CT, X-ray, MRI) or as > 10 mm with spiral CT scan.
    • Patients can be evaluated according to CA-125 if they have a pre-treatment sample that is at least twice the upper limit of normal and within 2 weeks prior to starting treatment. Patients are not evaluable if they have received mouse antibodies or if there has been medical and/or surgical interference with their peritoneum or pleura during the previous 28 days. E.g. paracentesis
    Patient with ascites requiring therapeutic drainage are eligible only if they have disease measurable by RECIST criteria. Ascitic sampling for pharmacodynamic analysis will only be taken in patients with disease measurable by RECIST criteria.
    Radiological measurements to assess response must be performed within 4 weeks prior to the patient going on study and at least 4 weeks after the last anti-cancer therapy.
    Clinical measurements must be done within one week of the patient going on study.

    5) WHO performance status of 0 to 2

    6) Haematological and biochemical indices within the ranges shown below. These measurements must be performed within one week before the patient goes on study.
    Lab Test Value Required
    Haemoglobin (Hb) ≥10.0 g/dl
    WBC ≥3.0 x 10(9)/L
    Neutrophils ≥1.5 x 10(9)/L
    Platelets (Plts) ≥100 x 10(9)/L
    Plasma bilirubin ≤30µmol/L
    ALT and/ or AST (If both are measured then both must satisfy these limits) ≤ 2.5 x upper limit of normal (ULN) unless due to tumour in which case up to 5 x ULN
    EDTA/DTPA clearance (radioisotope method) ≥50ml/min

    7) 18 years or over

    8) Written (signed and dated) informed consent and be capable of co-operating with treatment and follow-up

    E.4Principal exclusion criteria
    1) Radiotherapy, endocrine therapy, immunotherapy or chemotherapy during the previous four weeks before treatment.

    2) Toxic manifestations of previous treatments. Exceptions to this are alopecia and grade 1 neuropathy and certain Grade 1 toxicities which in the opinion of the Investigator and Cancer Research UK should not exclude the patient.

    3) Patients must not be intolerant of carboplatin where intolerance is defined as: with a dose of at least AUC 5:
    • Myelotoxicity causing dose delay on more than two occasions
    • Grade III or IV hypersensitivity reaction
    • Hospitalisation for febrile neutropenia (>38ºC)
    • Requirement for platelet transfusion

    4) Patients who have received more than 6 cycles of carboplatin.

    5) Ability to become pregnant (or already pregnant or lactating). However, those female patients who have a negative serum or urine pregnancy test before enrolment and agree to use appropriate medically approved contraception for four weeks before entering the trial, during the trial and for six months afterwards are considered eligible.

    6) Major thoracic and/or abdominal surgery in the preceding four weeks from which the patient has not recovered.

    7) At high medical risk because of non-malignant systemic disease including active uncontrolled infection.

    8) Known to be serologically positive for Hepatitis B, Hepatitis C or Human Immunodeficiency Virus (HIV).

    9) Current malignancies at other sites, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin. Cancer survivors, who have undergone potentially curative therapy for a prior malignancy, have no evidence of that disease for five years and are deemed at low risk for recurrence, are eligible for the study.

    10) 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)
    Any response (partial or complete) in any of the patients as determined by RECIST criteria or CA-125 levels in patients without measurable disease at baseline.
    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 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) Yes
    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 concerned9
    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
    last visit of the last patient 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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 state134
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 134
    F.4.2.2In the whole clinical trial 134
    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)
    Expected normal treatment
    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 Decision2006-10-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-11-30
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2008-12-17
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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
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