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    Summary
    EudraCT Number:2004-000572-14
    Sponsor's Protocol Code Number:EFC 6088 (XRP9881B/2001)
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-12-16
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2004-000572-14
    A.3Full title of the trial
    Phase II multicenter, open label, non-randomized study of intravenous RPR109881 q 3 weeks in patients with metastatic breast cancer progressing after therapy with anthracyclines, taxanes, and capecitabine.
    A.3.2Name or abbreviated title of the trial where available
    Not applicable
    A.4.1Sponsor's protocol code numberEFC 6088 (XRP9881B/2001)
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberNot applicable
    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 SponsorAventis Pharmaceuticals, Inc. (a subsidiary of sanofi-aventis group)
    B.1.3.4CountryUnited States
    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 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 nameNot applicable
    D.3.2Product code RPR109881
    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.3.9.2Current sponsor codeXRP9881
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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
    Metastatic breast cancer patients after failure to anthracyclines, taxanes and capecitabine.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Classification code 10055113
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the objective response rate of RPR109881 administered as a 1-hour infusion every 3 weeks in patients with metastatic breast cancer (MBC) relapsing or progressing after therapy with anthracyclines, taxanes, and capecitabine.
    E.2.2Secondary objectives of the trial
    -To assess the safety and tolerability of RPR109881 in this patient population.

    -To assess the impact of RPR109881 on pain control and analgesic use.

    -To assess the impact of RPR109881 on the maintenance of performance status.

    -To determine the effect of RPR109881 on clinical benefit as assessed by time to tumor response, duration of response, time to tumor progression, and overall survival.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    -Histologically or cytologically proven diagnosis of breast adenocarcinoma that is now metastatic or locally recurrent and inoperable. Patients with previously treated histo/cytologically confirmed disease who develop clinical or radiological evidence of metastatic disease do not require separate confirmation of the metastatic disease.

    -Patients must have been previously treated with an anthracycline, taxanes (docetaxel and/or paclitaxel), and capecitabine. These treatments may have been given in the adjuvant or metastatic setting, separately or combined. Patients must have received a standard dose of anthracycline, taxane and capecitabine expected to have potentially resulted in a response.

    -Evidence of measurable disease as defined by RECIST. Measurable lesions are lesions that can be accurately measured in at least one dimension with longest diameter superior or equal to 20mm. With spiral CT scan ,lesion must be superior or equal to 10mm in at least one dimension (slice thickness= 5-8 mm).

    -Completion of all prior chemotherapy, immunotherapy (including trastuzumab [Herceptin®]), targeted non-cytotoxic therapy, and radiotherapy superior or equal to 3 weeks prior to first treatment dose on study. Prior treatment with radiotherapy, chemoembolization therapy, or cryotherapy is allowed if these therapies did not affect the areas of measurable disease being evaluated for efficacy in this protocol. Patients may start or continue to receive bisphosphonate therapy as clinically indicated.

    -ECOG performance status of 0,1 or 2.

    -Patients who received chemotherapy in the adjuvant setting must not have received more than two previous chemotherapy regimens ( ie, a single or a combination of chemotherapy agents given until documented disease progression or relapse) for metastatic or locally recurrent and inoperable breast cancer. Patients who did not receive chemotherapy in the adjuvant setting must not have received more than three previous chemotherapy regimens for metastatic or locally recurrent and inoperable breast cancer. A chemotherapy regimen is defined as a single or a combination of chemotherapy agents given until documented disease progression or relapse.
    E.4Principal exclusion criteria
    -History of any second malignancy with the exception of adequately treated basal cell or squamous cell skin cancer, or in situ carcinoma of the cervix uteri. Inclusion of any other in situ cancer must be discussed with the sponsor. Patients with adequately treated contralateral breast cancer which has been disease-free for more than 5 years prior to first treatment dose on study are eligible.

    -Concurrent treatment with other anti-cancer therapy, including chemotherapy, immunotherapy (including trastuzumab [Herceptin®]), hormonal therapy, radiotherapy, chemoembolization therapy, cryotherapy, targeted therapy, or patients planning to receive these treatments.

    -Concurrent treatment with potent inhibitors of cytochrome P450 3A4, such as ketoconazole, itraconazole ,erythromycin, clarithromycin or patients planning to receive these treatments. For patients who were receiving treatment with such agents, a one-week washout period is required before first treatment dose on study.

    -Prior treatment with epothilones or with non-approved tubulin-interacting agents. Prior treatment with Abraxane® (nanoparticle albumin-bound paclitaxel) is permitted.

    -Prior participation in any other trials that involve RPR109881 with a survival endpoint to avoid compromising the results of such trials.

    -HER2-positive patients may participate in this trial. Concurrent treatment with trastuzumab (Herceptin®) is not permitted.

    -Known symptomatic brain or leptomeningeal involvement with cancer. Patients with a history of symptomatic brain involvement with cancer (i) must have had these lesions previously surgically removed or irradiated; (ii) must not be treated currently with corticosteroids; and (iii) must have documentation that the lesions are stable or improving by CT or MRI scan performed at least 3 months apart. For such patients, a baseline CT or MRI scan must be obtained less than or equal to 21 days prior to the first treatment dose on study. CT or MRI scan of the brain is required only in case of clinical suspicion of central nervous system involvement. Patients with asymptomatic untreated brain lesions are not excluded.

    -Known human immunodeficiency virus (HIV) infection currently requiring therapy, or acquired immunodeficiency syndrome (AIDS)-related illness.

    -Patients who are pregnant or breastfeeding.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable is the Response Rate (RR) defined as the proportion of patients with confirmed CR or confirmed PR, defined by RECIST criteria, relative to the total number of patients in the analysis population.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Clinical benefit
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) Information not present in EudraCT
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    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) 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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.5The trial involves multiple Member States Yes
    E.8.6 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 Information not present in EudraCT
    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 duration of this study is expected to take approximately 42 months, which includes the time necessary for the confirmatory radiological study to be performed (no less than 4 weeks after the criteria for response are met initially) on the last patient enrolled who responds after two cycles of therapy and for the determination of stable disease (requiring follow-up of 12 weeks or longer).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months8
    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 months6
    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 Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    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 2005-12-16. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    legally authorized representative must give consent in case of subjects incapable of giving consent personally.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 162
    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)
    After withdrawal from study treatment, patients will be treated by their physicians as determined by usual medical practice and followed to document any subsequent anticancer therapy and survival.
    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 Decision2006-01-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-01-19
    P. End of Trial
    P.End of Trial StatusCompleted
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