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    Summary
    EudraCT Number:2010-023648-34
    Sponsor's Protocol Code Number:HT-ANAM-301
    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:2012-03-07
    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 number2010-023648-34
    A.3Full title of the trial
    Anamorelin HCl in the Treatment of Non-Small Cell Lung Cancer – Cachexia (NSCLC-C): A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase III Study to Evaluate the Safety and Efficacy of Anamorelin HCl in Patients with NSCLC-C ROMANA 1
    Anamorelin HCl nel trattamento del carcinoma polmonare non a piccole cellule - Cachessia (NSCLC-C): Studio randomizzato, in doppio cieco, placebo-controllato, multicentrico di fase III per la valutazione della sicurezza e dell'efficacia di Anamorelin HCl in pazienti affetti da NSCLC-C ROMANA 1
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial studying the safety and effectiveness of the study drug Anamorelin HCl for treating cachexia (weight loss and muscle mass loss) in patients with Non-Small Cell Lung Cancer
    Sperimentazione clinica che studia la sicurezza e l'efficacia del farmaco sperimentale Anamorelin HCl per trattare la cachessia(perdita di peso e perdita di massa muscolare) in pazienti con carcinoma polmonare non a piccole cellule
    A.3.2Name or abbreviated title of the trial where available
    ROMANA 1
    ROMANA 1
    A.4.1Sponsor's protocol code numberHT-ANAM-301
    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 SponsorHELSINN THERAPEUTICS (U.S), 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 supportHELSINN THERAPEUTICS (U.S), INC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedpace, Inc.
    B.5.2Functional name of contact pointMedpace Regulatory Submissions
    B.5.3 Address:
    B.5.3.1Street AddressGmunder Strasse 53
    B.5.3.2Town/ cityMunich
    B.5.3.3Post code81379
    B.5.3.4CountryGermany
    B.5.4Telephone number49 89 895 57 180
    B.5.5Fax number49 89 895 571 81 00
    B.5.6E-mailregsubmissions@medpace.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 nameAnamorelin HCl
    D.3.2Product code NA
    D.3.4Pharmaceutical form 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 INNNA
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeAnamorelin HCl
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Non-Small Cell Lung Cancer related Cachexia (NSCLC-C)
    Cachessia (NSCLC-C) correlata a Carcinoma polmonare non a piccole cellule
    E.1.1.1Medical condition in easily understood language
    Weight-loss and lean body mass loss due to non-small cell lung cancer
    Perdita di peso e di massa corporea magra dovuta a carcinoma polmonare non a piccole cellule
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level SOC
    E.1.2Classification code 10027433
    E.1.2Term Metabolism and nutrition disorders
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. To evaluate the effect of Anamorelin HCl on lean body mass (LBM) as measured by dual energy X-ray absorptiometry (DXA) 2. To evaluate the effect of Anamorelin HCl on muscle strength as measured by handgrip strength (HGS)
    Valutare l’effetto di Anamorelin HCl sulla massa magra (LBM) misurata tramite assorbimetria a raggi X a doppia energia (DXA) 2. Valutare l’effetto di Anamorelin HCl sulla forza muscolare misurata tramite misurazione della forza di presa della mano (FPM)
    E.2.2Secondary objectives of the trial
    1. To evaluate the effect of Anamorelin HCl on body weight 2. To evaluate the effect of Anamorelin HCl on quality of life as assessed using the FACIT-F (Functional Assessment of Chronic Illness Therapy – Fatigue) and the FAACT (Functional Assessment of Anorexia/Cachexia Treatment) 3. To evaluate the effect of Anamorelin HCl on overall survival Exploratory Objective 1. To evaluate the effect of Anamorelin HCl on quality of life as assessed using the Hunger Assessment Scale Safety Objectives 1. To evaluate the safety and tolerability of Anamorelin HCl
    Valutare l’effetto di Anamorelin HCl sul peso corporeo 2. Valutare l’effetto di Anamorelin HCl sulla qualità della vita misurata usando la scala FACIT-F (Functional Assessment of Chronic Illness Therapy – Fatigue) e FAACT (Functional Assessment of Anorexia/Cachexia Treatment) 3. Valutare l’effetto di Anamorelin HCl sulla sopravvivenza complessiva Obiettivo esplorativo 1. Valutare l’effetto diAnamorelin HCl sulla qualità della vita misurata usando la Scala di misurazione della fame Obiettivi sulla sicurezza 1. Valutare la sicurezza e la tollerabilità di Anamorelin HCl
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Females and males at least 18 years of age • Documented histologic or cytologic diagnosis of AJCC Stage III or IV NSCLC. Stage III patients must have unresectable disease. • With regard to chemotherapy and/or radiation therapy: o Patients may be receiving maintenance chemotherapy after receiving first line chemotherapy. o Patients may be initiating a new chemotherapy (first or second line) and/or radiation therapy regimen at the time of randomization, but may not have started the regimen greater than 7 days before randomization. o Patients may have completed a chemotherapy and/or radiation therapy and/or have no plan to initiate a new regimen within 12 weeks from randomization. At least 14 days must elapse from the completion of the chemotherapy and/or radiation therapy prior to randomization. • Involuntary weight loss of 5% body weight within 6 months prior to screening or a screening BMI <20 kg/m2. Weights may have been measured or obtained and documented by patient history. • Body mass index less than/equal 30 kg/m2 • ECOG performance status less than/equal 2 (see Appendix I) • Estimated life expectancy of >4 months at the time of screening • Adequate hepatic function, defined as aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels less than/equal 5  upper limit of normal (ULN) • Adequate renal function, defined as creatinine less than/equal 2  ULN, or calculated creatinine clearance more than 30 ml/minute • The patient is able to understand and comply with the procedures for the HGS evaluation. • If the patient is a woman of childbearing potential or a fertile man, he/she must agree to use an effective form of contraception during the study and for 30 days following the last dose of study drug (an effective form of contraception is abstinence, a hormonal contraceptive, or a double-barrier method). • The patient must be willing and able to give signed informed consent and, in the opinion of the Investigator, to comply with the protocol tests and procedures.
    Uomini e donne di almeno 18 anni di età • Diagnosi citologica o istologica documentata di carcinoma polmonare non a piccole cellule (NSCLC) di stadio III o IV secondo il AJCC (Comitato congiunto americano sul cancro). I pazienti con carcinoma di stadio III devono presentare la malattia in stadio inoperabile. • In riferimento alla chemioterapia e/o radioterapia: - I pazienti possono sottoporsi a chemioterapia di mantenimento dopo aver ricevuto un ciclo di chemioterapia di prima linea. - I pazienti possono iniziare un nuovo ciclo di chemioterapia (di prima o seconda linea) e/o radioterapia al momento della randomizzazione, ma non devono aver iniziato il ciclo più di 7 giorni prima della randomizzazione. - I pazienti che hanno completato la chemioterapia e/o radioterapia e/o che non hanno pianificato di iniziare un nuovo ciclo entro 12 settimane dalla randomizzazione. Devono essere trascorsi almeno 14 giorni dal completamento della chemioterapia e/o radioterapia prima della randomizzazione. • La perdita involontaria di &gt;5% del peso corporeo nei 6 mesi precedenti lo screening o uno screening dell'indice di massa corporea &lt;20 kg/m2. I valori ponderali possono essere stati già misurati o ottenuti e documentati nella storia clinica del paziente. • Indice di massa corporea minore uguale a 30 kg/m2 • Stato di validità ECOG minore uguale a 2 (v. Appendice I); • Aspettativa di vita stimata &gt;4 mesi al momento dello screening • Funzione epatica adeguata, intesa con livelli di aspartato aminotransferasi (AST) e di alanina aminotransferasi (ALT) minore uguale a 5 x il limite superiore alla norma (ULN) • Funzione renale adeguata, intesa come creatinina minore uguale a 2 x ULN, o clearance della creatinina calcolata &gt;30 ml/minuto • Il paziente è in grado di comprendere e seguire le procedure per la misurazione della forza di presa della mano (FPM). • Se il paziente è una donna potenzialmente fertile o un uomo fertile,dovrà acconsentire all'uso di una forma efficace di contraccezione durante lo studio e nei 30 giorni successivi all'ultima dose del farmaco in studio (per forma di contraccezione efficace si intende astinenza sessuale, contraccettivo ormonale, o un metodo contraccettivo di doppia barriera) • Il paziente deve acconsentire ed essere in grado di firmare un consenso informato e, in base all'opinione del medico sperimentatore, essere conforme con i test e le procedure del protocollo.
    E.4Principal exclusion criteria
    • Other forms of lung cancer (e.g., small cell, mesothelioma) • Women who are pregnant or breast-feeding • Known HIV, hepatitis (B & C), or active tuberculosis • Patients who have completed 2 or more prior cytotoxic chemotherapy regimens • Had major surgery (central venous access placement and tumor biopsies are not considered major surgery) within 4 weeks prior to randomization. Patients must be well recovered from acute effects of surgery prior to screening. Patients should not have plans to undergo major surgical procedures during the treatment period. • Currently taking prescription medications intended to increase appetite or treat weight loss; these include, but are not limited to, testosterone, androgenic compounds, megestrol acetate, methylphenidate, and dronabinol • Patients unable to readily swallow oral tablets. Patients with severe gastrointestinal disease (including esophagitis, gastritis, malabsorption, or obstructive symptoms) or intractable or frequent vomiting are excluded. • Has an active, uncontrolled infection • Has uncontrolled diabetes mellitus • Has untreated clinically relevant hypothyroidism • Has known or symptomatic brain metastases • Patients receiving strong CYP3A4 inhibitors within 14 days of randomization (see Appendix VI) • Patients receiving tube feedings or parenteral nutrition (either total or partial). Patients must have discontinued these treatments for at least 6 weeks prior to Day 1, and throughout the study duration. • Other clinical diagnosis, ongoing or intercurrent illness that in the Investigator’s opinion would prevent the patient’s participation • Has had previous exposure to Anamorelin HCl • Patients actively receiving a concurrent investigational agent
    Altre forme di carcinoma polmonare (ad es. a piccole cellule, mesotelioma) • Donne in stato di gravidanza o in allattamento • Pazienti affetti da HIV conclamato, epatite (B e C) o tubercolosi attiva • Pazienti che hanno completato precedentemente 2 o più cicli di chemioterapia citotossica • Pazienti sottoposti ad operazioni di alta chirurgia (inserimento di catetere venoso centrale e biopsie tumorali non sono considerate operazioni di alta chirurgia) entro 4 settimane prima della randomizzazione. I pazienti devono essersi ripresi dagli effetti acuti di operazioni chirurgiche prima di effettuare lo screening. I pazienti non possono essere sottoposti ad operazioni di alta chirurgia durante il periodo di trattamento. • Pazienti che assumono farmaci con prescrizione medica intesi ad incrementare l'appetito o trattare la perdita di peso; ivi inclusi, e in via non esaustiva, testosterone, composti androgenici, megestrolo acetato, metilfenidato e dronabinolo • Pazienti che non sono in grado di inghiottire compresse. Pazienti affetti da malattie gastrointestinali acute (ivi incluse patologie quali esofagite, gastrite, sindrome da malassorbimento o sintomi ostruttivi) o con vomito intrattabile o frequente sono esclusi dallo studio. • Pazienti con infezione attiva e incontrollata • Pazienti con diabete mellito incontrollato • Pazienti con ipotiroidismo clinicamente rilevante e non trattato • Pazienti con metastasi celebrali sintomatiche o note • Pazienti a cui sono stati somministrati forti inibitori CYP3A4 almeno 14 giorni prima della randomizzazione (v. Appendice VI) • Pazienti a cui viene somministrata un'alimentazione per sonda o nutrizione parenterale (totale o parziale). I pazienti devono aver interrotto tali trattamenti per almeno 6 mesi prima del Giorno 1, e durante l'intero periodo studio. • Altre diagnosi cliniche, patologie in corso o intercorrenti che secondo l'opinione del medico sperimentatore possono escludere il paziente dallo studio • Pazienti con pregressa esposizione ad Anamorelin HCI • Pazienti sottoposti all'uso concomitante di altri farmaci sperimentali
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy Parameters: • LBM change from baseline as measured by DXA over 12 weeks • Change in HGS of the non-dominant hand from baseline over 12 weeks
    Variazione della massa magra rispetto al baseline misurata dall'esame DXA per un periodo di 12 settimane • Variazione della forza di presa della mano non dominante rispetto al baseline durante un periodo di 12 settimane
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks
    12 settimane
    E.5.2Secondary end point(s)
    • Percentage change from baseline over 12 weeks in LBM • Percentage change from baseline over 12 weeks in HGS of the non-dominant hand • Changes in body weight from baseline to Weeks 3, 6, 9, and 12 • Change in HGS of the dominant hand from baseline to Weeks 6 and 12 • Quality of life as assessed by FACIT-F and FAACT at baseline compared to Weeks 3, 6, 9, and 12 • Overall survival
    Parametri di efficacia secondaria: • Variazione percentuale nella massa magra rispetto al baseline durante un periodo di 12 settimane • Variazione percentuale della forza di presa della mano non dominante rispetto al baseline durante un periodo di 12 settimane • Variazioni di peso corporeo rispetto al baseline alle settimane 3, 6, 9 e 12 • Variazione della forza di presa della mano dominante rispetto al baseline alle settimane 6 e 12 • Qualità della vita misurata usando le scale FACIT-F e FAACT rispetto al baseline confrontata con i valori ottenuti alle settimane 3, 6, 9 e 12 • Sopravvivenza complessiva
    E.5.2.1Timepoint(s) of evaluation of this end point
    From 3 to 12 weeks according to the parameter specified above. Overall survival assessed until death up to 1 year.
    Da 3 a 12 settimane secondo il parametro, come specificato sopra. Sopravvivenza considerata fino alla morte ad un anno.
    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 Yes
    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) 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA33
    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
    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
    Patients will be followed for 1 year from randomization (every 3 months) for survival status. Patients who enter the extension study (HT-ANAM-303) will continue to participate in the survival follow-up for this study.
    I pazienti saranno seguiti per 1 anno dalla randomizzazione (ogni 3 mesi) per lo status della sopravvivenza. I pazienti che entrano nell'extension study (HT-ANAM-303) continueranno a partecipare al follow-up per la sopravvivenza per questo studio.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months37
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months37
    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: 317
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 160
    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 state43
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 414
    F.4.2.2In the whole clinical trial 477
    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)
    Patients will have an option of enrolling into an extension trial (HT-ANAM-303) after the last visit. Regardless of enrollment into the extension trial, all patients will be followed for 1 year from randomization (every 3 months) for survival status.
    I pazienti avranno la possibilità di arruolarsi in un extension trial (HT-ANAM-303)dopo l'ultima visita. Al di là dell'arruolamento nell'extension trial, tutti i pazienti verranno seguiti per un anno dopo la randomizzazione (ogni 3 mesi)per lo status della sopravvivenza.
    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 Decision2012-02-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-09-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-03-19
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