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    Summary
    EudraCT Number:2004-000838-36
    Sponsor's Protocol Code Number:PX104.1.7-201
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2004-07-13
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2004-000838-36
    A.3Full title of the trial
    A Phase II trial evaluating the immunological and clinical efficay and safety of HER-2 Protein Autovac(TM) monotherapy in patients with metastatic breast cancer
    A.3.2Name or abbreviated title of the trial where available
    NA
    A.4.1Sponsor's protocol code numberPX104.1.7-201
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) Number-
    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 SponsorPharmexa A/S
    B.1.3.4CountryDenmark
    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 Information not present in EudraCT
    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 nameHER-2 Protein AutoVac(TM)
    D.3.2Product code PX104.1.7
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 code104.1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.25
    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) 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) Yes
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Female patients with histologically proven metastatic or locally advanced breast cancer who have HER-2 overexpression in the primary tumour and/or a metastatic lesion.
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the trial is to demonstrate evidence of clinical efficacy of HER-2 Protein AutoVac(TM), that is the number of evaluable patients with evidence of clinical benefit, defined as:
    · A complete response (CR) or partial response (PR), or
    · Stable disease (SD) for at least 6 months (26 weeks).
    E.2.2Secondary objectives of the trial
    The secondary objectives of the trial are:
    · To obtain data on the immune response following long-term treatment.
    · To obtain safety data on long-term use.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Female breast cancer patients who fulfil the following criteria will be eligible for inclusion in the trial:
    1. Histological proven adenocarcinoma of the breast.
    2. Locally advanced or metastatic disease.
    3. Centrally confirmed HER-2 overexpression by either a score 3+ by DAKO HercepTest(TM) (DakoCytomation) or a positive DAKO HER2 FISH pharmDx(TM) (DakoCytomation) test result on either the primary tumour or metastasis. The HER-2 expression status of the patient MUST BE confirmed by the central laboratory before enrolment and the patient’s first vaccination with HER-2 Protein AutoVac(TM).
    4. At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumours (RECIST).
    5. Age less than or equal to 18 yearsand less than or equal to 80 years
    6. Life expectancy more than or equal to 6 months.
    7. Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1.
    8. Signed written informed consent prior to trial entry.
    9. Willing and able to comply with the protocol for the duration of the trial.
    10. No more than two prior chemotherapy regimens for locally advanced/metastatic disease (adjuvant chemotherapy after primary therapy is not counted as a regimen).
    11. No more than three prior lines of endocrine treatment for locally advanced/metastatic disease.
    E.4Principal exclusion criteria
    Patients will be excluded from the trial should they meet one or more of the following criteria:
    1. Women of child-bearing potential not using a reliable and appropriate contraceptive method. Pregnant and lactating women. Women of childbearing potential with either a positive or no pregnancy test at screening.
    2. Patients who have received chemotherapy or other immunosuppressive therapy within 4 weeks prior to start of study treatment.
    3. Patients who have received hormonal therapy within 4 weeks of starting study treatment.
    4. Radiotherapy involving more than 25% of the bone marrow given within 3 months before inclusion in the study.
    5. Patients who have previously been treated at any time with any HER-2 based anticancer vaccine.
    6. Patients who have been treated with any other anticancer vaccine within 1 year of starting study treatment.
    7. Patients who have previously been treated with Herceptin® (trastuzumab) or any other agents, commercially available or investigational, that target the HER-2 axis.
    8. Concurrent immunosuppressive therapy, including, but not limited to, low dose methotrexate or cyclophosphamide, corticosteroids (with the exception of topically applied/inhaled steroids). Concurrent anti-tumour treatment.
    9. Other cancers than breast cancer, except for basal cell carcinoma of the skin and in situ carcinoma of cervix.
    10. Patients with history of significant cardiovascular disease or left ventricular ejection fraction (LVEF) less than 50%, determined by echocardiogram or multiple gated acquisition (MUGA) scans.
    11. Uncontrolled hypertension.
    12. Participation in another clinical trial with an investigational agent within 30 days preceding initiation of treatment.
    13. Known infection of human immunodeficiency virus (HIV).
    14. History of or co-existing severe auto-immune diseases:
    - Auto-immune neutropaenia.
    - Auto-immune thrombocytopaenia.
    - Haemolytic anaemia.
    - Systemic lupus erythematosus.
    - Sjogren syndrome.
    - Scleroderma.
    - Myasthenia gravis.
    - Goodpasture syndrome.
    - Addison’s disease.
    - Hashimoto’s thyroiditis.
    - Active Graves’ disease.
    - Other diseases which qualify as auto-immune in origin.
    14. Significantly impaired immune function as judged by the investigator.
    15. Patients with any of the following abnormal baseline haematology values:
    - Haemoglobin less than 10 g/dL (6.2 mmol/L).
    - White blood cells (leukocytes) less than 3 x 109/L.
    - Lymphocytes less than 1 x 109/L.
    - Platelets less than 100 x 109/L.
    16. Patients with any of the following abnormal baseline liver function tests:
    - Serum bilirubin more than 1.5 x upper normal limit (UNL), except if the patient has a documented diagnosis of Gilbert’s syndrome.
    - g-Glutamyltransferase (GGT) more than 2.5 x UNL (or 5 x UNL in case of liver metastases).
    - Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) more than 2.5 x UNL (or 5 x UNL in case of liver metastases).
    17. Known renal dysfunction or the following abnormal baseline values:
    - Serum creatinine more than 1.5 x UNL.
    18. A history or clinical evidence of central nervous system (CNS) metastases.
    19. Any other serious medical, social or mental condition which, in the opinion of the investigator, would be detrimental to the patient or the trial.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the trial is clinical benefit rate, defined as:
    · Clinical Response or Partial Response, or
    · Stable Disease for at least 6 months (26 weeks).
    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 Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Kinetics of the immunological response
    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) 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 No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    A two-stage Phase II trial
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    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.8.5The trial involves multiple Member States Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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 be stopped when the last patient included reaches 26 weeks or when the last ongoing patient has been in the trial for at least 26 weeks or when all patients have discontinued treatment, whichever occurs first.
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 60
    F.4.2.2In the whole clinical trial 60
    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 Decision2004-09-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-09-01
    P. End of Trial
    P.End of Trial StatusCompleted
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