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    Summary
    EudraCT Number:2010-020835-38
    Sponsor's Protocol Code Number:IEOS550310
    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:2012-01-09
    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 number2010-020835-38
    A.3Full title of the trial
    “A phase II study of cisplatin plus cyclophospamide for patients with previously treated, advanced, triple receptor negative breast cancer”
    Studio di fase II con cisplatino e ciclofosfamide metronomica in pazienti con carcinoma mammario metastatico triplo negativo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    “A Phase II study evaluating the role of the combination of cisplatin and cyclophosphamide administered metronomically in patients with advanced breast cancer triple negative (Estrogen and progesterone receptors negative and c-erb B2 non overexpressed).
    “Studio di Fase II che valuta il ruolo della combinazione di due farmaci chemioterapici cisplatino e ciclofosfamide, somministrati in modalita' metronomica nelle pazienti affette da carcinoma mammario triple negativo (recettori estro progestinici non espressi e c-erb B2 non sovra espresso)”.
    A.4.1Sponsor's protocol code numberIEOS550310
    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 SponsorISTITUTO EUROPEO DI ONCOLOGIA
    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 supportIstituto Europeo Oncologia
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIstituto Europeo Oncologia
    B.5.2Functional name of contact pointUfficio studi clinici
    B.5.3 Address:
    B.5.3.1Street Addressvia Ramusio 1
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20141
    B.5.3.4CountryItaly
    B.5.4Telephone number02 57 48 98 48
    B.5.5Fax number02 57 48 97 81
    B.5.6E-mailufficio.studiclinici@ieo.it
    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 ENDOXAN BAXTER*50CPR RIV 50MG
    D.2.1.1.2Name of the Marketing Authorisation holderBAXTER SpA
    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 Coated 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 INNciclofosfamide
    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) 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 Yes
    D.3.11.13.1Other medicinal product typechemioterapico citostatico
    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 Yes
    D.2.1.1.1Trade name CISPLATINO TEVA IT*EV 100MG100
    D.2.1.1.2Name of the Marketing Authorisation holderTEVA ITALIA 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 No
    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 INNcis-diclorodiamminoplatino
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 Yes
    D.3.11.13.1Other medicinal product typeantineoplastico
    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
    Advanced, triple receptor negative breast cancer
    Carcinoma mammario metastatico ''triple negative''
    E.1.1.1Medical condition in easily understood language
    The combination cisplatin and cyclophosphamide will be offered to metastatic triple receptor negative breast cancer patients previously treated with anthracyclines and/or taxanes.
    pazienti affette da carcinoma mammario metastatico cosiddetto triple negative trattate con almeno una linea di chemioterapia per la malattia metastatica contenente antracicline e/o taxani.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10055113
    E.1.2Term Breast cancer metastatic
    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
    To evaluate objective response rate (ORR), defined as the percentage of all patients who experienced a Complete Response (CR) or Partial Response (PR) of the combination cisplatin and metronomic cyclophosphamide in patients with previously treated, triple receptor negative (ER/PR and HER2/neu), locally recurrent or metastatic breast cancer.
    Valutare in tasso di risposta obiettiva (ORR) della combinazione di ciclofosfamide metronomica e del cisplatino nelle pazienti con carcinoma mammario “triple negative” localmente avanzato o metastatico, precedentemente trattate con taxani e/o antracicline.
    E.2.2Secondary objectives of the trial
    To evaluate Time to Tumor Progression (TTP) of the combination cisplatin and metronomic cyclophosphamide in this patient population - To assess the safety of the combination cisplatin and metronomic cyclophosphamide - To examine the Health-Related Quality of Life (HRQoL) of the combination cisplatin and metronomic Cyclophosphamide
    Valutare il TTP della combinazione cisplatino e ciclofosfamide metronomica in questa popolazione - Determinare la safety della combinazione cisplatino e ciclofosfamide metronomica - Valutare la Qualità di vita (Health-Related Quality of Life) della combinazione di cisplatino e ciclofosfamide metronomica
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Histologically proven diagnosis of breast cancer with evidence of 1) unresectable, locally recurrent, or 2) metastatic disease. Locally recurrent disease must not be amenable to resection or radiation therapy with curative intent. • Documentation of Estrogen and Progestin Receptor (ER and PgR) negative status (immunohistochemistry 0%) and HER2/neu receptor negative status (i.e., FISH negative or immunohistochemistry 0 or +1). • Prior treatment with an anthracycline and/or a taxanes in the neoadjuvant, adjuvant or metastatic disease setting. • Measurable disease as per RECIST. Measurable lesions that have been previously radiated will not considered target lesions unless increase in size has been observed following completion of radiation therapy. • Female, 18 years of age or older. • ECOG performance status 0, 1 or 2. • Resolution of all acute toxic effects of prior therapy or surgical procedures to grade ≤ 1 (except alopecia). • The definitions of minimum adequacy for organ function required prior to study entry
    • Diagnosi istologica di carcinoma mammario dimostrata con evidenza di carcinoma mammario metastatico oppure localmente avanzato e non operabile • Carcinoma mammario “triple negative” (ER e PgR 0% ed assenza di sovraespressione determinata mediante immunoistochimica di c-erb B2 (o o 1+) o assenza di amplificazione genica (FISH negativo) • Precedente trattamento con antracicline e/o taxani nel setting neoadiuvante, adiuvante o metastatico • Malattia misurabile secondo criteri RECIST • Donne di età ≥ 18 anni • ECOG performance status ≤ 2 • Risoluzione di tutti gli effetti tossici acuti dell’eventuale precedente trattamento antineoplastico fino ad un grado ≤ 1 • Adeguata funzionalità epatica, renale e midollare
    E.4Principal exclusion criteria
    • Major surgery, radiation therapy, or systemic therapy within 3 weeks of study enrollment except palliative radiotherapy to non-target metastatic lesions. • Uncontrolled brain metastases, spinal cord compression, carcinomatous meningitis, or leptomenigeal disease. Patients should have completed surgery or radiation therapy for existing brain metastases, should not have documented increase in size over the previous 3 months prior to first dose of treatment on study and should be asymptomatic. • Diagnosis of any second malignancy within the last 3 years, except for contralateral breast cancer also with triple negative receptor status, adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervic. • Any of the following within the 2 months prior to starting study treatment: myocardial infarction, severe/unstable angina, congestive heart failure, cerebrovascular accident including transient attack, or pulmonary embolus not correlated to the breast cancer. • Ongoing cardiac dysrhythmias of NCI CTCAE grade ≥ 2 or atrial fibrillation of any grade. • Current treatment with therapeutic doses of coumarin or oral anti-vitamin K agents such as warfarin and phenprocoumon derivates. Low molecular weight heparin is allowed at any dose level. • Known human immunodeficiency virus infection. • Female who is pregnant or nursing; female of child-bearing potential who is unwilling or unable to use adequate contraception to prevent pregnancy during the trial and for 3 months after the last dose of study treatment. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to randomization. Female patients must be surgically sterile or be in postmenopausal, or must agree to use effective contraception during the period of therapy and for 3 months after the last dose of study treatment. • Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which in the judgment of the investigator, would make the patient inappropriate for entry into this study. • Acute kidney injury or failure within 3 months prior to starting study treatment. • Current treatment with drug-related nephrotoxic effects. • Ongoing condition described as 'urethral' (or 'dysuria/frequency') syndrome.
    • Chirurgia maggiore, radioterapia o terapia antineoplasia sistemica entro 3 settimane dall’arruolamento ad eccezione di radioterapia sintomatica su una sede non target dolente. • Metastasi del S.N.C. non controllate dal punto di vista sintomatologico, compressione midollare conseguente alla neoplasia, carcinomatosi meningea. I pazienti con metastasi cerebrali sottoposte a chirurgia e/o radioterapia encefalica, dovrebbero avere una stazionarietà delle lesioni cerebrali negli ultimi 3 mesi prima dell’avvio del trattamento sperimentale • Diagnosi di una seconda neoplasia maligna entro gli ultimi 3 anni, ad eccezione di un carcinoma mammario controlaterale triple negative, carcinomi squamocellulari della pelle adeguatamente trattati o carcinoma in situ della cervice • Una delle seguenti comorbidità nei 3 mesi precedenti l’avvio del trattamento sperimentale: o Infarto del miocardio o Angina severa/instabile o Insufficienza cardiaca congestizia o Eventi cerebrovascolari, inclusi TIA o Embolia polmonare non oncologica o non correlata a accessi venosi centrali • Aritmie NCI CTCAE grado ≥ 2 in atto o una fibrillazione atriale di qualsiasi grado • Trattamento concomitante con dicumarolici o vitamina K orale o warfarin • HIV • Donne gravide • Donne in età fertile che non vogliono o non sono in grado di attuare adeguati metodi anticoncezionali per evitare una gravidanza durante il trattamento sperimentale e per 3 mesi dopo il termine del trattamento con cisplatino e ciclofosfamide • Altre malattie gravi acute o condizioni psichiatriche scompensate o anormalità di laboratorio che a giudizio dell’investigatore sono a rischio per la partecipazione della paziente allo studio • Insufficienza renale acuta o entro 3 mesi dall’inizio del trattamento sperimentale • Trattamenti medici concomitanti con potenziali rischi nefrotossici
    E.5 End points
    E.5.1Primary end point(s)
    Objective response rate (ORR), defined as the percentage of all patients who experienced a Complete Response (CR) or Partial Response (PR).
    Determinare l’Overall Response Rate (ORR), definita come la percentuale di tutte le pazienti che ottengono una completa risposta (RC) o una risposta parziale (PR).
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 months
    24 mesi
    E.5.2Secondary end point(s)
    time to progression
    tempo alla progressione
    E.5.2.1Timepoint(s) of evaluation of this end point
    24 months
    24 mesi
    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 Yes
    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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    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.8.2.4Number of treatment arms in the trial1
    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 No
    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
    LVLS
    LVLS
    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
    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.1.1.2Preterm 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.1.2.1Number of subjects for this age range: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 state48
    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)
    NORMAL MEDICAL CARE
    NORMALE ASSISTENZA MEDICA
    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 Decision2011-09-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-06-22
    P. End of Trial
    P.End of Trial StatusOngoing
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