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    Summary
    EudraCT Number:2010-021961-61
    Sponsor's Protocol Code Number:VOS-AML-301
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-12-30
    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 ConcernedUK - MHRA
    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.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of vosaroxin or placebo in combination with cytarabine in in patients with first relapsed or refractory acute myeloid leukemia.
    A.3.2Name or abbreviated title of the trial where available
    VALOR
    A.4.1Sponsor's protocol code numberVOS-AML-301
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01191801
    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 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 supportSunesis Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSunesis Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointDeborah A. Thomas
    B.5.3 Address:
    B.5.3.1Street Address395 Oyster Point Boulevard, Suite 400
    B.5.3.2Town/ citySouth San Francisco
    B.5.3.3Post codeCA 94080
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1 650 2663728
    B.5.5Fax number+1 620 266 3728
    B.5.6E-maildthomas@sunesis.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 nameVosaroxin
    D.3.2Product code Vosaroxin
    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 INNvosaroxin
    D.3.9.1CAS number 175414-77-4
    D.3.9.3Other descriptive namevoreloxin (former name)
    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) 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 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
    Relapsed or refractory acute myeloid leukemia
    E.1.1.1Medical condition in easily understood language
    Rare blood cancer requiring treatment
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10060558
    E.1.2Term Acute myeloid leukemia recurrent
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10054296
    E.1.2Term Acute myeloid leukemia NOS
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to 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
    The following substudy will be conducted at sites in the United States only:

    Electrocardiographic and pharmacokinetic substudy (addendum to protocol VOS-AML-301). Original addendum, dated 03 September 2010.

    Approximately 30 patients in each treatment group will participate in this substudy, at approximately 15 to 20 study sites. The effect on cardiac repolarization, as measured by QTcF, will be evaluated for patients treated with vosaroxin (90 mg/m2, the highest dose administered in the study) versus placebo in combination with cytarabine. On days 1 and 4 of induction 1, digital 12‑lead ECGs will be recorded continuously using a Holter monitor before each vosaroxin or placebo dose through 23 hours after the start of study drug administration. The ECGs will be read and the assessment of QTc will be performed by a cardiologist blinded to treatment assignment at a central cardiac safety services facility.

    Sparse time‑matched blood samples will be obtained to determine concentrations of vosaroxin, cytarabine, and their relevant metabolites for PK and PK‑PD evaluation.
    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.5.1.1Timepoint(s) of evaluation of this end point
    The primary enpoint analyses will be conducted after the required number of events (deaths) has occured (357).

    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.
    E.5.2Secondary end point(s)
    The secondary efficacy endpoint is complete remission rate, defined as the percentage of patients whose response is a complete remission based on IWG response criteria.

    The secondary safety endpoint is the incidence of AEs.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The primary enpoint analyses will be conducted after the required number of events (deaths) has occured (357).

    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.
    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.8.2.4Number 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 EEA62
    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
    Australia
    Austria
    Belgium
    Canada
    Czech Republic
    France
    Germany
    Hungary
    Italy
    Korea, Republic of
    New Zealand
    Poland
    Spain
    United Kingdom
    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
    After end of treatment, follow up will document survival status for all patients and disease status for patients in contiuing CR, CRp, or CRi. In addition, any nonprotocol treatments for AML will be recorded. Follow-up after the end of treatment will continue until notification that the required nymber of events (deaths) has occurred. Long-term follow-up is to document survival status on all ongoing patients after notification that the required number of events (deaths) has occured.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    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 years7
    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: 500
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 250
    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 state26
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 340
    F.4.2.2In the whole clinical trial 750
    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 completion of the trial, it is standard of care that patients may, depending on outcome and health status, go on to receive subsequent AML treatment. This may include further chemotherapy or hematopoietic stem cell transplant. Patients may also receive palliative or hospice care.
    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 Decision2011-01-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-04-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-02-01
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