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    Summary
    EudraCT Number:2010-021961-61
    Sponsor's Protocol Code Number:VOS-AML-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:2011-02-21
    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 number2010-021961-61
    A.3Full title of the trial
    A Phase 3, Randomized, Controlled, Double-Blind, Multinational Clinical Study of the Efficacy and Safety of Vosaroxin and Cytarabine Versus Placebo and Cytarabine in Patients With First Relapsed or Refractory Acute Myeloid Leukemia(VALOR)
    A.3.2Name or abbreviated title of the trial where available
    VALOR
    A.4.1Sponsor's protocol code numberVOS-AML-301
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberND
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSUNESIS 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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 namevosaroxin
    D.3.2Product code vosaroxin
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNvosaroxin
    D.3.9.1CAS number 175414-77-4
    D.3.9.2Current sponsor codevosaroxin
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 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
    First Relapsed or Refractory Acute Myeloid Leukemia
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10060558
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10054296
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Compare overall survival (OS) between treatment groups of patients treated with vosaroxin and cytarabine versus patients treated with placebo and cytarabine
    E.2.2Secondary objectives of the trial
    • Compare complete remission (CR) rate based on International Working Group (IWG) response criteria, between treatment groups Compare safety and tolerability between treatment groups
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    FARMACOCINETICA/FARMACODINAMICA: Versione:addendum Data:2010/09/03 Titolo:Sottostudio di elettrocardiografia e farmacocinetica (addendum al protocollo VOS-AML-301, datato 03 Settembre 2010 (solo per gli Stati Uniti). Obiettivi:Circa 30 pazienti in ogni gruppo di trattamento in 15-20 centri negli Stati Uniti saranno arruolati in questo sottostudio. L`effetto sulla ripolarizzazione cardiaca, come misura del QTcF, sara` valutata nei pazienti trattati con vosaroxin (90 mg/m2, la piu` alta dose somministrata nello studio) verso placebo e citarabina. Al giorno 1 e 4 dell`induzione 1,gli ECG digitali a 12 derivazioni saranno registrati continuativamente utilizzando un monito Holter prima di ogni dose di vosaroxin o placebo fino a 23 ore dopo l`inizio della somministrazione del farmaco. Gli ECG saranno letti e la valutazione delle onde QT sara` effettuata da un cardiologo all`oscuro del trattamento assegnato presso la la struttura dei servizi di sicurezza cardiaca centrale. Occasionalmente, corrispondenti campioni di sangue saranno ottenuti per determinare le concentrazioni di vosaroxin, citarabina, e i loro principali metaboliti per valutazioni di PK, e PK-PD
    E.3Principal inclusion criteria
    1. Able to understand and provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization, as appropriate 2. At least 18 years of age 3. Diagnosis of acute myeloid leukemia (AML) by World Health Organization (WHO) classification 4. Relapsed or refractory AML with at least 5% blasts by bone marrow biopsy or aspirate, or at least 1% blasts in peripheral blood, and meeting the criteria for relapsed or refractory AML detailed in section 4.1 of the protocol 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 6. Local clinical laboratory values as follows: - Serum creatinine ≤ 2.0 mg/dL - Total bilirubin ≤ 1.5 x the upper limit of normal (ULN), unless due to Gilbert’s syndrome - Aspartate aminotransferase (AST) ≤ 2.5 x ULN - Alanine aminotransferase (ALT) ≤ 2.5 x ULN 7. Left ventricular ejection fraction (LVEF) at least 40% by multiple gated acquisition (MUGA) scan or echocardiogram (ECHO) 8. Clinically significant nonhematologic toxicity after prior chemotherapy has recovered to grade 1 per Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 or newer 9. Females must be surgically or biologically sterile or postmenopausal (amenorrheic for at least 12 months) or if of childbearing potential, must have a negative urine or serum pregnancy test within 14 days before the first vosaroxin or placebo administration, and must agree to use an adequate method of contraception during the study until 30 days after the last treatment. Males must be surgically or biologically sterile or agree to use an adequate method of contraception during the study until 30 days after the last treatment
    E.4Principal exclusion criteria
    1. Acute promyelocytic leukemia (APL) 2. More than 2 cycles of induction therapy for AML 3. Refractory to or relapsed ≤ 90 days after any induction or consolidation therapy with an intermediate or high dose cytarabine (IDAC or HIDAC) regimen containing a cumulative dose of ≥ 5 g/m2 cytarabine 4. Transplantation for AML (either allogeneic or autologous) ≤ 90 days of randomization or on active immunosuppressive therapy for graft versus host disease (GVHD) within 2 weeks before the first dose of vosaroxin or placebo 5. Central nervous system (CNS) involvement of active AML 6. Other active malignancies (including other hematologic malignancies) or other malignancies within the last 12 months, except nonmelanoma skin cancer or cervical intraepithelial neoplasia 7. Uncontrolled active infection of any type - Infections under control with antibiotic treatment are acceptable - Chronic hepatitis is acceptable 8. Uncontrolled invasive fungal infection (positive blood or tissue culture) 9. History of myocardial infarction (MI), unstable angina, cerebrovascular accident, or transient ischemic attack (CVA/TIA) within 3 months before the first dose of vosaroxin or placebo 10. Prior or current therapy: - Hydroxyurea or other oral medications to reduce blast count within 24 hours before the first dose of vosaroxin or placebo - Treatment with an investigational product within 14 days before the first dose of vosaroxin or placebo, or not recovered from all acute effects of previously administered investigational products 11. Hemodialysis or peritoneal dialysis required 12. Prior exposure to vosaroxin 13. Pregnant or breastfeeding 14. Any other medical, psychological, or social condition that may interfere with study participation or compliance, or compromise patient safety in the opinion of the investigator or medical monitor
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is overall survival (OS) in the intent-to-treat population. Analysis of OS will be based on the log-rank test weighted to account for the adaptive design. Kaplan-Meier methods will be used to estimate OS for each treatment group. Sensitivity analyses will be performed to assess the effect of subsequent therapy, and specifically transplantation, on OS. One formal interim efficacy analysis will be performed after reaching 187 events (deaths) (50% of the required number of 375 events). At the discretion of the data and safety monitoring board (DSMB), one of the following actions will be taken at the interim analysis: terminate for efficacy, terminate for futility, increase the accrual to a maximum of 750 patients and extend the observations in the study beyond the prespecified 375 events, or continue the study as planned. The primary safety endpoint is 30- and 60-day all cause mortality, summarized with point estimates and 95% confidence intervals.
    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) 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.8.3 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA67
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    dopo l`ultima visita dell`ultimo pz,il FU raccogliera` informazioni sulla sopravvivenza di tutti i pz(endpoint primario)fino a morte, ritiro del ICF, perdita al FU (la sopravvivenza media attesa e` di 5-7 mesi).
    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 years2
    E.8.9.2In all countries concerned by the trial months11
    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.1.3Elderly (>=65 years) Yes
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 340
    F.4.2.2In the whole clinical trial 750
    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 Decision2011-08-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-02-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-02-01
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