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    Summary
    EudraCT Number:2011-001298-17
    Sponsor's Protocol Code Number:362/11
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-03-06
    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 number2011-001298-17
    A.3Full title of the trial
    Phase II study on ET-743 in BRCA1 and BRCA2 mutation carrie and BRCAness phenotype advanced ovarian cancer patients.
    Studio di fase II su ET-743 (Yondelis) in pazienti con carcinoma ovarico avanzato con mutazione di BRCA1 e BRCA2 e con fenotipo BRCAness
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase II study aiming at evaluating activity of Yondelis in recurrent ovarian cancer patients with BRCA mutation
    Studio clinico di fase 2 finalizzato a valutare l'attivita' dello Yondelis nelle pazienti con recidiva di carcinoma dell'ovaio con la mutazione genetica BRCA.
    A.4.1Sponsor's protocol code number362/11
    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 SponsorPOLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
    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 supportPharmamar
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIstituto di ginecologia ed ostetricia
    B.5.2Functional name of contact pointGinecologia oncologica
    B.5.3 Address:
    B.5.3.1Street AddressL.go Gemelli 8
    B.5.3.2Town/ cityRoma
    B.5.3.3Post code00168
    B.5.3.4CountryItaly
    B.5.4Telephone number0630156279
    B.5.5Fax number0630157241
    B.5.6E-mailginecol1@rm.unicatt.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 YONDELIS*EV 1FL POLV 1MG
    D.2.1.1.2Name of the Marketing Authorisation holderPHARMA MAR S.A.
    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 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 INNTRABECTEDIN
    D.3.9.1CAS number 114899-77-3
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.5
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    advaced ovarian cancer
    Carcinoma dell'ovaio avanzato
    E.1.1.1Medical condition in easily understood language
    ovarian cancer
    carcinoma ovarico
    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 HLT
    E.1.2Classification code 10033129
    E.1.2Term Ovarian neoplasms malignant (excl germ cell)
    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 determine the feasibility in terms of objective response rate by RECIST version 1.1 (Complete and Partial Response [CR + PR]) with trabectedin in patients with BRCA1 or BRCA2 mutation carrier or BRCAness phenotype advanced ovarian cancer patients.
    determinare la fattibilità in termini di risposta obiettiva secondo i criteri Recist (Complete and Partial Response [CR + PR]) in pazienti con carcinoma ovarico avanzato con mutazione del BRCA1 o BRCA2 e fenotipo BRCAness trattate con trabectedina.
    E.2.2Secondary objectives of the trial
    • Duration of response. • Progression-free survival [the diagnosis of progression will be assessed by radiological criteria; CA 125 increases alone (GCIG criteria of progression) will not be considered as progression of disease without a radiological confirmation of progression]. • Safety profile of trabectedin in this patient population
    - Durata della risposta - Progressione libera da malattia (PFS) - Profilo di sicurezza della trabectedina nella popolazione di pazienti in studio
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    PHARMACOGENETIC:
    Vers:2.1
    Date:2011/12/20
    Title:farmacogenetic evaluation of response to trabectedine in recurrent ovarian cancer
    Objectives:To evaluate if the espression of specifc genes correlate with response to trabectedine
    FARMACOGENETICA:
    Vers:2.1
    Data:2011/12/20
    Titolo:valutazione farmacogenetica della risposta alla trabectedina nelle pazienti con carcinoma ovarico avanzato
    Obiettivi:valutare se l'espressione di alcuni geni si correla alla risposta al trattamento con trabectedina
    E.3Principal inclusion criteria
    1. Patients with partially platinum sensitive ovarian cancer (platinum-free interval 6-12 months) who have previously received at least two platinum based chemotherapy lines, BRCA mutated or with BRCAness phenotype Definition of BRCAness phenotype: high-grade serous cancers, great initial sensitivity to platinum drugs and retention of platinum-sensitivity through multiple relapses, long history of disease, long survival, long TFIs between relapses (patients with high personal risk factors will be included after doing the analysis for BRCA 1-2 mutation before knowing the results). BRCA 1 and/or BRCA 2 mutation carriers (patients with established mutation will be included, patients with high personal risk factors will be included after doing the analysis before knowing the results) 2. Patients with platinum resistant ovarian cancer, BRCA mutated or with BRCAness phenotype who have previously received at least two previous chemotherapy lines (including platinum rechallenge)3. Patient’s written informed consent before any clinical trial-specific procedure. 4. 18 years-of-age or older. 5. Measurable disease as defined in the Response Evaluation Criteria in Solid Tumors (RECIST) Guidelines 6. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1. 7. Hematologic variables: a. Hemoglobin ≥9 g/dL b. Absolute neutrophil count (ANC) ≥1,500/μL, and c. Platelet count ≥100,000/μL. 8. Serum creatinine ≤ 1.5 mg/dL or creatinine clearance ≥ 30 mL/min 9. Creatinine phosphokinase (CPK) ≤ 2.5 ULN. 10. Hepatic function variables a. Total bilirubin ≤ ULN. b. Total alkaline phosphatase ≤ 2.5 ULN c. AST (serum aspartate transaminase [SGOT]) and ALT (serum alanine transaminase [SGPT]) must be ≤2.5 x ULN. 11. Albumin ≥ 25 g/l. 12. Adequately recovered from the acute toxicity of any prior treatment
     Pazienti con carcinoma ovarico parzialmente sensibile al platino (platinum-free interval 6-12 mesi) che abbiano ricevuto il platino per almeno 2 volte e che siano BRCA mutate o fenotipo BRCA ness  Pazienti con malattia resistente al platino che abbiano effettuato almeno due precedenti linee di chemioterapia a base di platino che presentino la mutazione del BRCA 1 O 2  Fenotipo BRCAness: carcinoma sieroso di alto grado, alta sensibilità iniziale al platino e dopo multiple recidive platino-sensibili, lunga storia di malattia, lunga sopravvivenza, TFI lungo tra le recidive  Consenso informato scritto della paziente prima di qualsiasi procedura relativa al protocollo  Età superiore ai 18 anni  Malattia misurabile come definito dal Response Evaluation Criteria in Solid Tumors (RECIST) Guidelines  Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 o 1  Valori ematologici: emoglobina ≥9 g/dL, neutrofili ≥1,500/μL, piastrine ≥100,000/μL. creatinina ≤ 1.5 mg/dL o creatinina clearance ≥ 30 mL/min creatinina fosfochinasi (CPK) ≤ 2.5 ULN.  Funzionalità epatica bilirubina totale ≤ ULN. Fosfatasi alcalina ≤ 2.5 ULN AST (serum aspartate transaminase [SGOT]) e ALT (serum alanine transaminase [SGPT]) deve essere ≤1.5 x ULN. Albumina ≥ 25 g/l.  Recupero adeguato dalla tossicità acuta di qualsiasi trattamento precedente
    E.4Principal exclusion criteria
    1. Prior exposure to trabectedin. 2. Known hypersensitivity to any of the components of the trabectedin i.v. formulation or dexamethasone. 3. More than two prior chemotherapy lines given in patients with resistant, BRCA mutated, ovarian cancer (including platinum rechallenge). 4. More than 3 prior chemotherapy lines given in patients with partially platinum sensitive, BRCA mutated and/or BRCAness phenotype ovarian cancer recurrences (including platinum rechallenge) 5. Less than 4 weeks from last dose of therapy with any investigational agent, or chemotherapy. 6. History of another neoplastic disease (except basal cell carcinoma or cervical carcinoma in situ adequately treated) unless in remission for 3 years or longer. 7. Known clinically relevant CNS metastases. 8. Other serious illnesses, such as: • Congestive heart failure or angina pectoris; myocardial infarction within 1 year before enrollment; uncontrolled arterial hypertension or arrhythmias • Psychiatric disorder that prevents compliance with protocol • Active viral hepatitis; or chronic liver disease • Active infection • Any other unstable medical conditions
     Precedente trattamento con trabectedina  Nota ipersensibilità ad uno dei componenti della formulazione ev. di trabectedina o al desametasone  Più di 2 precedenti linee di chemioterapia in pazienti con resistenza primaria o acquisita al platino (incluso platino rechallenge)  Più di tre precedenti linee di chemioterapia in pazienti con recidiva tra 6 e 12 mesi dal precedente platino(pazienti parzialmente sensibili), incluso il platinum re-challenge  Meno di quattro settimane dall’ultima dose di terapia con farmaci sperimentali, o altra chemioterapia  Precedente o concomitante neoplasia maligna (eccetto il carcinoma baso-cellulare o il carcinoma cervicale in situ adeguatamente trattato) a meno che in remissione da 3 anni o più  Metastasi cerebrali note clinicamente rilevanti  Patologie serie concomitanti:  Insufficienza cardiaca congestizia o angina pectoris; infarto del miocardio nell’ anno precedente all’arruolamento; ipertensione arteriosa incontrollata o aritmie  Disordini psichiatrici che impediscono l’adesione al protocollo  Epatite virale attiva; o malattia epatica cronica  Infezione attiva  Qualsiasi altra condizione clinica instabile
    E.5 End points
    E.5.1Primary end point(s)
    Response rate
    Response rate
    E.5.1.1Timepoint(s) of evaluation of this end point
    63 days
    63 giorni
    E.5.2Secondary end point(s)
    duration of response PFS Safety
    o Durata della risposta o Progressione libera da malattia (PFS) o Profilo di sicurezza della trabectedina nella popolazione di pazienti in studio
    E.5.2.1Timepoint(s) of evaluation of this end point
    63 days
    63 giorni
    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 No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 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) 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 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 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
    The date of progression of disease of the last enrolled patients
    Fino all'ultima progressione di malattia dell'ultimo soggetto arruolato
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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: 67
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 33
    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 state100
    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)
    outpatients visit
    visite ambulatoriali
    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 Decision2012-04-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-09-22
    P. End of Trial
    P.End of Trial StatusCompleted
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