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    Summary
    EudraCT Number:2010-019909-42
    Sponsor's Protocol Code Number:113172
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2011-03-31
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2010-019909-42
    A.3Full title of the trial
    A double-blind, randomized, placebo-controlled, Phase I/II Study evaluating the safety, immunogenicity and clinical activity of neoadjuvant treatment with WT1-A10 + AS15 Antigen-Specific Cancer Immunotherapeutic in combination with standard therapy in patients with WT1-positive Stage II or III breast cancer.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    NA
    A.3.2Name or abbreviated title of the trial where available
    WT1-AS15-BRS-001 (NEOADJ)
    A.4.1Sponsor's protocol code number113172
    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 SponsorGlaxoSmithKline Biologicals
    B.1.3.4CountryBelgium
    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 nameWT1-A10 + AS15
    D.3.2Product code WT1-A10 + AS15
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeWT1-A10 protein
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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) Yes
    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 placeboConcentrate and solvent for solution for injection
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Neoadjuvant treatment of WT1-positive Stage II or III breast cancer. Patients will receive the WT1-A10 + AS15 ASCI in combination with standard neodjuvant therapy. Patients will be recruited in three parallel cohorts (Cohort A, B and C) according to the standard neoadjuvant treatment they will receive (aromatase inhibitor, chemotherapy or chemotherapy combined with trastuzumab).
    E.1.1.1Medical condition in easily understood language
    Breast Cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level PT
    E.1.2Classification code 10006201
    E.1.2Term Breast cancer stage III
    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 13.1
    E.1.2Level PT
    E.1.2Classification code 10006200
    E.1.2Term Breast cancer stage II
    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
    This is a multi-center, parallel three-cohorts, randomized (2:1), double-blinded, placebo-controlled exploratory Phase I/II study in the neoadjuvant setting.
    The Phase I segment of the study will per cohort evaluate the safety and immunogenicity of WT1-A10 + AS15 ASCI administration in combination with standard treatment. For each cohort independently, in the absence of a safety signal and if the ASCI induces an adequate immune response in the context of the standard therapy, this cohort will proceed to the Phase II segment and additional patients will be recruited.
    The Phase II segment of the study aims to further assess the safety, immunogenicity and the clinical activity of WT1-A10 + AS15 ASCI in combination with standard treatment per cohort and in the overall population.
    In addition, the study aims to characterize the tumor microenvironment before treatment, the influence of treatment on this microenvironment, and the correlation of these with clinical response.
    E.2.2Secondary objectives of the trial
    There are no secondary objectives.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.The patient is at least 18 years of age at the time the informed consent to screening has been obtained.
    2. The patient has proven T1 with lymph node involvement or T2-T4c, any N, M0 primary invasive breast cancer, histologically confirmed by core needle biopsy.
    Isolated supraclavicular lymph node involvement is allowed.
    3. The patient’s tumor shows WT1 antigen expression, detected by quantitative RT-PCR or any updated technique at the time of sample analysis.
    4. The patient has one of the following histologically confirmed breast cancer subtypes:
    •Estrogen receptor (ER) and/or progesterone (PgR) positive tumor
    •HER2-overexpressing breast cancer
    •HER2-negative breast cancer.
    5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at the time of randomization.
    6. Baseline LVEF of equal or more than 50% as measured within two weeks (but by preference one week) prior to randomization by echocardiography or MUGA scan.
    7. The patient shows normal organ function.
    8. A female patient of childbearing potential may be enrolled in the study, if the patient:
    •has practiced adequate contraception for 30 days prior to study product administration, and
    •has a negative pregnancy test within one week prior to randomization, and
    •has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the study product administration series.
    E.4Principal exclusion criteria
    1. The patient has inflammatory breast cancer, which is defined as clinically significant erythema of the breast and/or documented dermal lymphatic invasion (not direct skin invasion by tumor or peau d'orange without erythema).
    2. Diagnosis established by incisional biopsy.
    3. Prior and concomitant neoadjuvant anti-breast-cancer treatments such as chemotherapy, immunotherapy / biological response modifiers, endocrine therapy, and radiotherapy, unless authorized specifically by the protocol.
    4. The patient is known to be human immunodeficiency virus (HIV)-positive.
    5. The patient has symptomatic autoimmune disease such as, but not limited to multiple sclerosis, lupus, and inflammatory bowel disease. Patients with vitiligo are not excluded.
    6. The patient is known to have difficult-to-control hypertension, coronary artery disease, arrhythmia requiring treatment, clinically significant valvular disease, cardiomegaly on chest X-ray, ventricular hypertrophy on ECG or previous myocardial infarction or congestive heart failure.
    7. The patient has a history of allergic reactions likely to be exacerbated by any component of the investigational product used in the study.
    8. The patient has other concurrent severe medical problems, unrelated to the malignancy, that would significantly limit full compliance with the study or expose the patient to unacceptable risk.
    9. The patient has (or has had) previous or concomitant malignancies at other sites, except effectively treated malignancy that is considered by the investigator highly likely to have been cured.
    10. The patient has psychiatric or addictive disorders that may compromise his/her ability to give informed consent or to comply with the study procedures.
    11. The patient has received any investigational or non-registered product (e.g., drug or vaccine) within 30 days preceding the first dose of study products or planned use during the study period.
    12. The patient requires concomitant treatment with any immunosuppressive agents or with systemic corticosteroids prescribed for chronic treatment (more than seven consecutive days).
    13. The patient is receiving full-dose subcutaneous heparins or is under anti-coagulation treatment (e.g., phenprocoumon).
    E.5 End points
    E.5.1Primary end point(s)
    Phase I segment
    Safety: Occurrence of severe toxicities during the whole study duration i.e.,
    1. A Grade 3 or higher toxicity that is related or possibly related to the combined administration of standard treatment and WT1-A10 + AS15 ASCI/placebo. Grade 3 myalgia, athralgia, headache, fever, rigors/chills and fatigue (including lethargy, malaise and asthenia) should persist for 48 hours despite therapy in order to be considered as a severe toxicity.
    2. A decrease in LVEF from baseline with 10 points or more and at <50% that is related or possibly related to the combined administration of standard treatment and WT1-A10 + AS15 ASCI/placebo and that is confirmed by a second LVEF assessment within approximately three weeks.
    3. A Grade 2 (i.e., asymptomatic with testing that suggests ischemia; stable angina) or higher cardiac ischemia/infarction that is related or possibly related to the combined administration of standard treatment and WT1-A10 + AS15 ASCI/placebo.
    4. A Grade 2 or higher allergic reaction occurring within 24 hours following the WT1-A10 + AS15 ASCI/placebo administration.
    5. Blood/bone marrow toxicity that is considered as related or possibly related to the combined administration of standard treatment and WT1-A10 + AS15 ASCI/placebo, i.e.,
    •In the absence of concomitant chemotherapy/trastuzumab
    (i.e., Cohort A):
    A Grade 3 or higher toxicity i.e.,
    - The hemoglobin level < 8,0 g/dL
    - The leukocyte count < 2,000 /mm3
    - The neutrophil count < 1,000 /mm3
    - The platelet count < 50,000/ mm3
    • In case of concomitant chemotherapy/trastuzumab
    (i.e., Cohort B or C):
    A Grade 3 or higher toxicity NOT resolved to Grade 1 or less within five weeks post last chemotherapy administration.
    6. A decrease in renal function at the time of WT1-A10 + AS15 ASCI/placebo administration that is considered as related or possibly related to the combined administration of standard treatment and WT1-A10 + AS15 ASCI/placebo and evaluated by a calculated creatinine clearance < 40 mL/min.

    Immunogenicity: The anti-WT1 humoral response post-WT1-A10 + AS15 ASCI/placebo dose 3, evaluated using a blood sample collected at Visit 4.

    Phase II segment
    Safety:
    -Occurrence of severe toxicities during the whole study duration.
    -Occurrence of adverse events and serious adverse events during the study treatment period and ending 30 days after the last study treatment administration, including abnormal hematological and biochemical parameters.
    -Occurrence of serious adverse events related to study treatment during the whole study duration.
    Immunogenicity:
    -The anti-WT1 and anti-CpG7909 humoral response.
    -The anti-WT1 T-cell response.
    Clinical endpoints:
    -The pathological response (complete response or partial response) in the breast and axillary nodes at the definitive surgery.
    -Disease free survival.
    -Overall survival.

    The presence of a predictive tumor gene expression profile at baseline, during and post-neoadjuvant treatment.
    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 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 Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity, translational research
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    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
    Last visit of the last patient participating in the trial.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months6
    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.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 180
    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)
    expected normal treatment of that condition.
    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 Decision2011-06-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-05-11
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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