Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2013-003953-13
    Sponsor's Protocol Code Number:PPHM1202
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2014-03-13
    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 number2013-003953-13
    A.3Full title of the trial
    A Phase III, Randomized, Double-Blind, Placebo-Controlled Multicenter Trial of Bavituximab Plus Docetaxel versus Docetaxel Alone as Second-Line Therapy in Patients with Stage IIIb/IV Non-Squamous Non-Small-Cell Lung Cancer
    Studio di fase III, multicentrico, randomizzato, in doppio cieco, controllato verso placebo, per valutare Bavituximab in combinazione con Docetaxel rispetto a Docetaxel in monoterapia come terapia di seconda linea in pazienti affetti da carcinoma polmonare non a piccole cellule non-squamoso di stadio IIIb/IV
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase 3 study of bavituximab plus docetaxel versus docetaxel alone in patients with late-stage non-squamous non-small-cell lung cancer
    Studio di fase III per valutare Bavituximab in combinazione con Docetaxel rispetto a Docetaxel in monoterapia in pazienti affetti da carcinoma polmonare non a piccole cellule non-squamoso in stadio avanzato.
    A.3.2Name or abbreviated title of the trial where available
    SUNRISE
    SUNRISE
    A.4.1Sponsor's protocol code numberPPHM1202
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01999673
    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 SponsorPeregrine Pharmaceuticals, 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 supportPeregrine Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPeregrine Pharmaceuticals, Inc
    B.5.2Functional name of contact pointManager, Clinical Research
    B.5.3 Address:
    B.5.3.1Street Address14282 Franklin Avenue
    B.5.3.2Town/ cityTustin
    B.5.3.3Post codeCA 92780
    B.5.3.4CountryUnited States
    B.5.4Telephone number1855291-SUNR 7867
    B.5.5Fax number17143883870
    B.5.6E-maillungcancertrial@peregrineinc.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 nameBavituximab
    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.3.9.1CAS number 648904-28-3
    D.3.9.2Current sponsor codech3G4
    D.3.9.3Other descriptive nameBavituximab
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number24
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 typeBavituximab is a chimeric (human/mouse) phosphatidylserine targeting monoclonal antibody of the immunoglobulin G subclass (IgG 1).
    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 placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Stage IIIb/IV Non-Squamous Non Small-Cell Lung Cancer
    Carcinoma polmonare non a piccole cellule non-squamoso di stadio IIIb/IV
    E.1.1.1Medical condition in easily understood language
    late-stage non-squamous non-small-cell lung cancer
    Carcinoma polmonare non a piccole cellule non-squamoso in fase avanzata
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10029522
    E.1.2Term Non-small cell lung cancer stage IV
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10029521
    E.1.2Term Non-small cell lung cancer stage IIIB
    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 compare the OS of patients with stage IIIb/IV non-squamous NSCLC receiving second-line treatment with bavituximab plus docetaxel or placebo plus docetaxel
    mettere a confronto la sopravvivenza globale (OS) di pazienti affetti da carcinoma polmonare non a piccole cellule (NSCLC) non squamoso di stadio IIIb/IV che ricevono trattamento di seconda linea con bavituximab in combinazione con docetaxel o placebo in combinazione con docetaxel.
    E.2.2Secondary objectives of the trial
    • To compare PFS and ORR in patients receiving treatment with bavituximab plus docetaxel or placebo plus docetaxel
    • To compare safety (AEs and clinical laboratory measurements) in patients receiving treatment with bavituximab plus docetaxel or placebo plus docetaxel
    • Confrontare la sopravvivenza libera da progressione (PFS) e il tasso di risposta globale (ORR) in pazienti che ricevono trattamento con bavituximab in combinazione con docetaxel o placebo in combinazione con docetaxel
    • Confrontare la sicurezza (eventi avversi e misurazioni di laboratorio clinico) in pazienti che ricevono trattamento con bavituximab in combinazione con docetaxel o placebo in combinazione con docetaxel
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Men and women at least 18 years of age
    • Histologically or cytologically confirmed and documented stage IIIb/IV non-squamous NSCLC according to the American Joint Committee on Cancer Staging Manual, 7th Edition
    • Radiographic disease recurrence or progression during or after front-line, platinum-based doublet chemotherapy. For patients with known EGFR-activating mutations or ALK translocations, appropriate targeted treatment should have been used. Mutation testing is not required
    • ECOG performance status of 0 or 1
    • Adequate hematologic, renal, and hepatic function
    1. Soggetti di sesso maschile o femminile di almeno 18 anni.
    2. NSCLC non squamoso di stadio IIIb /IV istologicamente o citologicamente confermato e documentato secondo l'American Joint Committee on Cancer Staging Manual (7^ edizione)
    3. Recidiva o progressione della malattia rilevata all'esame radiografico durante o dopo trattamento chemioterapico doppio di prima linea a base di platino. I pazienti con note mutazioni attivanti EGFR o traslocazioni di ALK devono aver manifestato progressione in seguito a trattamento mirato appropriato (oppure intolleranza al trattamento mirato appropriato).
    4. Una valutazione radiologica sulla terapia di prima linea deve aver evidenziato una malattia stabile o una risposta al trattamento dopo almeno 2 cicli.
    5. Stato di performance ECOG 0 o 1
    6. Funzione ematologica, renale ed epatica adeguata
    E.4Principal exclusion criteria
    • Squamous, small-cell, carcinoid, adenosquamous, large-cell neuroendocrine, or mixed histology containing small-cell or squamous-cell NSCLC
    • Known history of bleeding disorders, eg, von Willebrand disease or hemophilia
    • Cavitary tumors or tumors invading or abutting large blood vessels
    • Clinically significant bleeding such as gross hematuria, GI bleeding, and hemoptysis within 6 months of screening
    • Thromboembolic events (eg, deep vein thrombosis, pulmonary embolism, arterial thrombosis) within 6 months of screening
    • Grade 2 or higher peripheral neuropathy
    1. Tumore a istologia squamosa, a piccole cellule, carcinoide, adenosquamosa, neuroendocrina a grandi cellule o mista contenente piccole cellule o cellule squamose
    2. Nota anamnesi di diatesi emorragica o coagulopatia (come ad esempio malattia di von Willebrand o emofilia)
    3. Tumori cavitari o tumori che invadono o confinano con i grandi vasi sanguigni
    4. Sanguinamento clinicamente rilevante come ad esempio ematuria macroscopica, sanguinamento gastrointestinale ed emottisi entro 6 mesi prima dello screening
    5. Eventi tromboembolici (per esempio trombosi venosa profonda, embolia polmonare, trombosi arteriosa) entro 6 mesi prima dello screening.
    6. Neuropatia periferica di grado 2 o superiore
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is OS, defined as the number of days from randomization until death, regardless of cause.
    L’endpoint primario di efficacia è OS, definito come il numero di giorni dalla randomizzazione fino al decesso, indipendentemente dalla causa.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Endpoints are evaluated at each scheduled visit (please refer to Protocol section 6)
    Gli endpoint vengono valutati ad ogni visita programmata (si prega di fare riferimento al protocollo sezione 6)
    E.5.2Secondary end point(s)
    Efficacy
    • PFS: number of days from randomization until either death regardless of cause, or radiologically confirmed progressive disease (PD)
    • ORR: percentage of patients who achieve complete (CR) or partial (PR) response

    Tumor assessments for the determination of PFS and ORR will be according to modified RECIST 1.1 as secondary endpoints. Key modifications of the RECIST 1.1 criteria will include:
    • Selection of up to 10 target lesions, 5 per organ
    • New non-nodal lesions < 1 cm are considered equivocal. New nodes ≥ 1 cm but < 1.5 cm in short axis are considered equivocal.

    Safety
    • AEs
    • laboratory measurements: hematology (CBC with platelets and differential, biochemistry, and anti-drug antibodies [ADAs])
    • vital signs

    Population PK
    • nonlinear mixed effects modeling to evaluate intrinsic (eg, age, gender, race, weight, height, etc.) and extrinsic factors (eg, smoking) that could influence bavituximab exposure and/or response
    • assessments of exposure-response relationships for safety and efficacy
    • assessments of the effect of body size on the PK of bavituximab

    Exploratory
    • Immunological studies
    • Lung Cancer Symptom Scale (LCSS) at baseline, Cycles 3 and 5, every 9 weeks during maintenance therapy, and end of treatment
    • Potential evidence of radiological pseudoprogression and possible flare effect in patients receiving bavituximab plus docetaxel versus placebo plus docetaxel
    Efficacia
    • PFS: numero di giorni dalla randomizzazione fino al decesso indipendentemente dalla causa o malattia progressiva (PD) confermata con esame radiografico.
    • ORR: Percentuale di pazienti che raggiungono la risposta completa (CR) o parziale (PR)
    Le valutazioni del tumore per la determinazione di PFS e ORR saranno eseguite in conformità ai RECIST 1.1 modificati come endpoint secondari: Le modifiche principali dei criteri RECIST 1.1 includeranno:
    • Selezione di un numero massimo di 10 lesioni target, 5 per organo
    • Nuove lesioni non-nodali < 1 cm sono considerate ambigue. Nuovi noduli ≥ 1 cm ma < 1,5 cm sull'asse corto sono considerati lesioni ambigue

    Sicurezza:
    • Eventi Avversi
    • Misurazioni di laboratorio: ematologia (CBC con piastrine e
    differenziale, biochimica, e anticorpi anti-farmaco [ADAs])
    • segni vitali

    Farmacocinetica della popolazione:

    • modellazione a effetti misti non lineari per valutare i fattori intrinseci (per esempio età , sesso, razza, peso, altezza ecc) e fattori estrinseci ( per esempio l'abitudine al fumo) che potrebbero influire sull'esposizione e/o la risposta a bavituximab.
    • valutazioni dei rapporti di esposizione -risposta per sicurezza ed efficacia
    • Valutazioni degli effetti delle dimensioni corporee sulla farmacocinetica di bavituximab.

    Esplorativi:

    • Studi immunologici
    • Scala dei sintomi del carcinoma polmonare (LCSS) al basale, al ciclo 3 e 5, ogni 9 settimane durante la terapia di mantenimento e al termine del trattamento.
    • Potenziale evidenza di pseudo-progressione radiologica e possibile effetto di riacutizzazione in pazienti che ricevono bavituximab in combinazione con docetaxel, rispetto a placebo in combinazione con docetaxel
    E.5.2.1Timepoint(s) of evaluation of this end point
    Endpoints are evaluated at each scheduled visit (please refer to Protocol section 6)
    Gli endpoint vengono valutati ad ogni visita programmata (si prega di fare riferimento al protocollo sezione 6)
    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 No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Quality of Life
    Qualità della vita
    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 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) 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.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA100
    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
    Belgium
    France
    Greece
    Italy
    Romania
    Australia
    Germany
    Hungary
    Korea, Republic of
    Spain
    Poland
    Russian Federation
    Singapore
    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 trial will end when the required number of events has been reached and the database is clean and locked for analysis. Sponsor may stop the study (and/or the study site) for any reason with appropriate notification.
    Lo studio terminerà quando il numero di eventi è stato raggiunto e il database è pulito e bloccato per l'analisi. Lo Sponsor può interrompere lo studio (e / o il centro dello studio), per qualsiasi motivo con una notifica.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months9
    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.1.1.1In 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: 435
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 147
    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 state55
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 345
    F.4.2.2In the whole clinical trial 582
    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 completing end of treatment visit procedures, patients who are no longer receiving any study treatments and have experienced confirmed disease progression and/or have initiated subsequent anticancer therapy will enter long-term survival follow-up.
    Dopo aver completato le procedure della visita di fine del trattamento, i pazienti che non stanno più ricevendo alcun trattamento in studio e hanno progressione della malattia confermata e / o hanno iniziato una terapia antitumorale successiva entreranno nel follow-up di sopravvivenza a lungo termine.
    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 Decision2014-03-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-07-04
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2017-03-01
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sat Apr 20 10:28:08 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA