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    Summary
    EudraCT Number:2011-006134-17
    Sponsor's Protocol Code Number:IPM3002
    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:2012-06-12
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2011-006134-17
    A.3Full title of the trial
    A Multi-center, Open-Label, Adaptive, Randomized Study of Palifosfamidetris, a Novel DNA Crosslinker, in Combination with Carboplatin and Etoposide (PaCE) Chemotherapy versus Carboplatin and Etoposide (CE) Alone in Chemotherapy Naïve Patients with Extensive-Stage Small Cell Lung Cancer
    Studio multicentrico, in aperto, randomizzato e adattivo di palifosfamide-tris, un nuovo DNA crosslinker, in combinazione con chemioterapia con carboplatino ed etoposide (PaCE) versus la sola chemioterapia con carboplatino ed etoposide (CE) in pazienti con carcinoma polmonare a piccole cellule in fase estensiva naive alla chemioterapia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The MATISSE Study
    Studio MATISSE
    A.4.1Sponsor's protocol code numberIPM3002
    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 SponsorZIOPHARM ONCOLOGY, INC
    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 supportZiopharm Oncology Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationZiopharm Oncology Inc.
    B.5.2Functional name of contact pointMelinda Snyder
    B.5.3 Address:
    B.5.3.1Street AddressOne First Avenue, Parris Building 34, Navy Yard
    B.5.3.2Town/ cityBoston, MA
    B.5.3.3Post code02129
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1 617 778-1757
    B.5.5Fax number+1 617 241-2855
    B.5.6E-mailmsnyder@ziopharm.com
    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 No
    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 namePolifosfamide-tris
    D.3.2Product code NA
    D.3.4Pharmaceutical form Powder for solution for injection
    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 INNPalifosfamide (isophosphoramide mustard)
    D.3.9.1CAS number 31645-39-3
    D.3.9.2Current sponsor codePalifosfamide-tris, IPM-tris, ZIO-201-T
    D.3.9.3Other descriptive namePalifosfamide-tris
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number350
    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
    Small Cell Lung Cancer
    Carcinoma polmonare a piccole cellule
    E.1.1.1Medical condition in easily understood language
    Lung cancer
    Carcinoma polmonare
    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 10041068
    E.1.2Term Small cell lung cancer extensive stage
    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 compare the efficacy of palifosfamide-tris in combination with carboplatin and etoposide (PaCE) chemotherapy to carboplatin and etoposide (CE) alone, as measured by overall survival (OS), in chemotherapy naïve subjects with extensivestage SCLC
    L'obiettivo primario di questo studio è confrontare l’efficacia della palifosfamide-tris in combinazione con la chemioterapia con carboplatino ed etoposide (PaCE) rispetto al solo carboplatino ed etoposide (CE), come provato dalla sopravvivenza complessiva (Overall Survival, OS), in soggetti con carcinoma polmonare a piccole cellule in fase estensiva naive alla chemioterapia
    E.2.2Secondary objectives of the trial
    The secondary objectives are to: - Assess secondary efficacy endpoints including time to progression, objective response rate (ORR), response duration, and effects on quality of life (QOL) and disease-related symptoms. - Assess potential prognostic factors for OS (i.e., performance status, age, and gender). - Assess the safety of PaCE chemotherapy in the study population. - Collect tumor tissue samples for future analyses of potential biomarkers that may correlate with objective tumor response and/or clinical outcome.
    Gli obiettivi secondari sono:- Valutazione degli endpoint secondari inclusa la sopravvivenza senza progressione,il tasso di risposta obiettiva (Objective Response Rate,ORR),la durata della risposta obiettiva,gli effetti sulla qualità della vita (Quality Of Life,QOL) e sui sintomi correlati alla malattia.- Valutare i fattori prognostici potenziali per la OS (ovvero,performance status,età e sesso).- Valutare la sicurezza della chemioterapia PaCE nella popolazione in studio.- Raccogliere campioni di tessuto tumorale per analisi future di potenziali biomarcatori che potrebbero essere correlati alla risposta tumorale obiettiva e/o all’esito clinico.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    · Documented extensive-stage small cell lung cancer · Patient has received no prior chemotheraphy, adjuvant therapy, or radiotherapy for lung cancer · ECOG Perforamce Status of 0, 1 or 2 · Adequate bone marrow and organ function based on the results of protocol- specified laboratory tests · Male and female patients must agree to use a highly reliable method of birth control during study participation · Able to provide informed consent
    - Diagnosi di carcinoma polmonare a piccole cellule in fase estensiva. - Nessuna chemioterapia pregressa, terapia adiuvante o radioterapia per carcinoma polmonare. - ECOG performance status di 0, 1 o 2. - Midollo osseo e funzione organi adeguati come stabilito dai requisiti di laboratorio specificati nel protocollo - Soggetti maschi e femmine dovranno acconsentire a utilizzare un metodo contraccettivo altamente affidabile durante la partecipazione allo studio. - Consenso informato scritto.
    E.4Principal exclusion criteria
    · Previously untreated (non-irradiated), symptomatic brain metastases · Known allergy to any of the study drugs or their excipients · Any unstable or clinically significant concurrent medical condition that would, in the opinion of the investigator, jeopardize the safety of a patient and/or their compliance with the protocol, based on screening tests, physical examination and medical history (as specifically defined in the clinical protocol). · Any malignancy other than small cell lung cancer within the last 5 years prior to randomization, with the exception of cervical carcinoma in situ, nonmelanoma skin cancer, or superficial bladder tumors (Ta, Tis, or T1) that have been successfully and curatively treated with no evidence of recurrent or residual disease. (Exception: Subjects with a history of malignancy other than small cell lung cancer may be enrolled after consulation with the medical monitor provided the patient's prognosis is best defined by the extensive-stage small cell lung cancer). · Currently pregnant or nursing.
    - Metastasi sintomatiche al cervello non precedentemente trattate (non irradiate). - Allergie note a qualsiasi dei farmaci in studio o degli eccipienti. - Condizione patologica concorrente instabile o clinicamente significativa, disturbo psichiatrico o situazione sociale che potrebbe, secondo lo sperimentatore, compromettere la sicurezza del soggetto e/o la sua conformità al protocollo. - Altre malignità diverse dal carcinoma polmonare a piccole cellule nei 5 anni precedenti la randomizzazione, ad eccezione di carcinomi cervicali in sede, tumori non melanomatosi della cute o della vescica, superficiali (Ta, Tis o T1) trattate con successo senza alcuna prova di malattia ricorrente o residua. (Eccezione: i soggetti con anamnesi di malignità diverse dal SCLC potranno essere arruolati dopo una consultazione con il responsabile del monitoraggio medico, a condizione che la prognosi del paziente sia meglio definita da ES-SCLC). - Gravidanza in corso o in allattamento
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable, overall survival, is defined as the time from randomization to the date of death.
    La variabile primaria sull'efficacia è la sopravvivenza complessiva, definita come il tempo dalla randomizzazione alla data del decesso
    E.5.1.1Timepoint(s) of evaluation of this end point
    The study design uses an adaptive group sequential approach with sample size reestimation at the interim analysis. This interim analysis will be performed after 125 deaths have been observed.
    Il disegno dello studio utilizza un approccio sequenziale del gruppo adattivo con rivalutazione della dimensione del campione per l’analisi ad interim. L’analisi ad interim sarà eseguita dopo che saranno stati osservati 125 decessi.
    E.5.2Secondary end point(s)
    For study purposes, data for tumor-related endpoints (e.g., ORR) will be determined by the investigators according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.1 Tumor-related secondary efficacy variables are defined as the following: - TTP (time to progression): Time from randomization to the first date of PD. For subjects who have not progressed at the time of analysis, their TTP will be censored as of their last date of disease evaluation. Death due to disease is considered to be progressive disease. - Objective response rate (ORR): Proportion of subjects achieving a confirmed PR or CR according to RECIST v1.1 during study treatment or within 21 days following termination of study treatment. All objective responses (CR or PR) require confirmation by a repeat tumor assessment at least 4 weeks (28 days) after the response is first observed in order for the response to be considered confirmed. - Objective response duration: Time from the date of first objective response (PR or CR), with subsequent confirmation, until the date of PD or the occurrence of death (if death occurs earlier). Duration of response in subjects who have not progressed or died at the time of analysis will be censored as of the date of their last tumor assessment.
    Ai fini dello studio, i dati degli endpoints legati al tumore (es. ORR)saranno valutati dagli sperimentatori in base ai Criteri di valutazione della riposta nei tumori solidi (Response Evaluation Criteria In Solid Tumors, RECIST) linee guida v 1.1.1. Le variabili secondarie sull'efficacia relative al tumore sono le seguenti: - TTP (tempo dalla progressione): Tempo dalla randomizzazione alla prima PD. Per i pazienti non in progressioni al momento dell'analisi, TTP sarà censita come la data dell'ultima valutazione di malattia. La morte dovuta alla malattia è considerata progressione di malattia. Percentuale di risposta oggettiva (ORR): proporzione dei soggetti che raggiungono remissione completa o parziale. secondo RECIST v 1.1 durante il trattamento in studio o entro 21 giorni dal termine del trattamento in studio. Tutte le risposte oggettive (CR o PR) richiedono conferma con ripetizione della misurazione del tumore almeno 4 settimane (28 giorni) dopo la prima risposta osservata, prima di essere considerati confermati. - Durata della risposta ooggettiva: tempo dalla data della prima risposta oggettiva(PR o CR), con conseguente conferma, fino alla data di PD o il decesso (se avviene prima la morte). Durata della risposta nei soggetti che non hanno progredito o sono morti al momento dell'analisi verranno censiti come data dell'ultima misurazione del tumore.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary efficacy endpoints include ORR, PFS, duration of response and changes in QOL and disease-related symptoms. Tumor-related endpoints will be assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 guidelines.
    Gli endpoint secondari includono ORR, PFS, durata della risposta e cambiamenti di QOL e sintomi correlati alla malattia. Gli endpoint legati al tumore saranno valutati in base ai Criteri di valutazione della riposta nei tumori solidi (Response Evaluation Criteria In Solid Tumors, RECIST) linee guida v1.1
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    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 Yes
    E.8.2.3.1Comparator description
    Carboplatino ed Etoposide (trattamento di backgrou
    Carboplatin and Etoposide (background treatment)
    E.8.2.4Number of treatment arms in the trial2
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA41
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Israel
    Korea, Republic of
    Russian Federation
    Taiwan
    Ukraine
    United States
    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 date that all randomized subjects have completed protocol defined
    survival follow-up.
    La data in cui tutti i soggetti randomizzati hanno terminato il follow-up di sopravvivenza definito da protocollo
    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.1.1Number 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: 328
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 220
    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 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 state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 535
    F.4.2.2In the whole clinical trial 548
    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)
    Following end of participation in the trial subjects will return to standard of care therapy for lung cancer according to national and local regulations.
    Al termine della partecipazione allo studio i soggetti torneranno alle terapie standard per il cancro polmonare come da regolamentazione locale e nazionale.
    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 Decision2012-06-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-05-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-12-02
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