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    Summary
    EudraCT Number:2015-003492-29
    Sponsor's Protocol Code Number:391402
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2015-11-30
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2015-003492-29
    A.3Full title of the trial
    A Phase 1/2a, Open-Label, Parallel, Two-Arm, Dose-Escalation
    Study to Assess the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of BAX69 in Subjects with Refractory Ovarian Cancer with Malignant Ascites
    I/IIa. fázisú, nyílt, párhuzamos, kétkaros, dózisnövelő vizsgálat a BAX69 biztonságosságának, tolerálhatóságának, hatásosságának, farmakokinetikai és farmakodinámiás tulajdonságainak értékelésére, rosszindulatú ascitesszel járó, refrakter petefészekrákban szenvedő betegek esetében
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An early development study of BAX69 in patients with ovarian cancer with the accumulation of fluid in the abdomen.
    A.3.2Name or abbreviated title of the trial where available
    Phase 1/2a Two-Arm, Dose-Escalation of BAX69 in subjects with Malignant Ascites of Ovarian Cancer
    A.4.1Sponsor's protocol code number391402
    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 SponsorBaxalta Innovations GmbH
    B.1.3.4CountryAustria
    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 supportBaxalta Innovations GmbH
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBaxalta Innovations GmbH
    B.5.2Functional name of contact pointClinical Project Managers
    B.5.3 Address:
    B.5.3.1Street AddressBaxalta US Inc. 650 East Kendall Street
    B.5.3.2Town/ cityCambridge, MA
    B.5.3.3Post code02142
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1 617 588 8126
    B.5.5Fax number1 617 620 6514
    B.5.6E-mailmatt.mockler@baxalta.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 nameHuman recombinant MIF antibody
    D.3.2Product code BAX69
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraperitoneal use
    Intravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBAX69
    D.3.9.2Current sponsor codeBAX69
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 Yes
    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
    Refractory Ovarian Cancer with
    Malignant Ascites
    E.1.1.1Medical condition in easily understood language
    Cancer of the Ovaries
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10057529
    E.1.2Term Ovarian cancer metastatic
    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
    These objectives are applicable to each Arm separately:
    1. To determine the MTD and RP2D of imalumab
    2. To compare puncture-free survival (PuFS) to puncture-free interval at baseline
    E.2.2Secondary objectives of the trial
    These objectives are applicable to each Arm separately:
    1. To compare time to first paracentesis post-treatment to puncture-free interval at baseline
    2. To compare the ascites volume per unit time before and after imalumab treatment
    3. To assess the changes in ascites-related symptoms with imalumab treatment
    4. To assess the safety, tolerability, and immunogenicity of imalumab 5. To characterize the PK profile of imalumab in plasma
    6. To assess quality of life (QoL) using the European Organization for Research and Treatment of
    Cancer Quality of Life Core Questionnaire 30 (EORTC QLQ-C30) with imalumab treatment
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Optional Pharmacogenetic (DNA research) Sub-study
    E.3Principal inclusion criteria
    1. Provision of a signed informed consent
    2. Female subjects of non-childbearing potential, 18 years of age and older at the
    time of screening
    3. Anticipated life expectancy >3 months at the time of screening
    4. Metastatic ovarian epithelial cancer that is platinum resistant, and has no better
    option available in the investigator’s opinion
    5. Recurrent symptomatic malignant ascites having required 2 paracentesis within a 30-day interval prior to screening
    6. ECOG PS of 0 to 2
    7. Adequate hematological function, defined as:
    Platelet count ≥100,000/μL
    Prothrombin time (PT) and activated partial thromboplastin time (aPTT)
    <1.5 times the upper limit of normal (ULN)
    Absolute neutrophil count ≥1,000/μL
    Hemoglobin ≥9 g/dL, without the need for transfusion in the 2 weeks prior to
    screening
    8. Adequate renal function, defined as serum creatinine ≤2.0 times ULN and
    creatinine clearance >50 mL/min or eGFR >50 mL/min/1.73 m2
    9. Adequate liver function, defined as:
    Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)
    ≤2.5 times ULN for subjects without liver metastases, or ≤5 times ULN in the
    presence of liver metastases
    Bilirubin ≤2.0 times ULN, unless subject has known Gilbert’s syndrome
    10. Adequate venous access
    11. Subject is willing and able to comply with the requirements of the protocol
    E.4Principal exclusion criteria
    1. Known central nervous system metastases
    2. Prior malignancy within the past 3 years, with the exception of curatively treated
    basal or squamous cell carcinoma of the skin, ductal carcinoma in situ of breast,
    in situ cervical carcinoma, and superficial bladder cancer
    3. Subjects who have an indwelling draining intraperitoneal catheter
    4. Residual AEs >Grade 2 from previous treatment
    5. Myocardial infarction within 6 months prior to C1D1, and/or prior diagnoses of
    congestive heart failure (New York Heart Association Class III or IV), unstable
    angina, unstable cardiac arrhythmia requiring medication; and/or the subject is at
    risk for polymorphic ventricular tachycardia (eg, hypokalemia, family history or
    long QT syndrome)
    6. Uncontrolled hypertension defined as systolic blood pressure ≥160 mmHg and/or
    diastolic blood pressure ≥100 mmHg confirmed upon repeated measures
    7. Left ventricular ejection fraction <40% as determined by echocardiogram
    (ECHO) performed at screening or within 90 days prior to C1D1
    8. QT/QTc interval >450 msec, before C1D1 treatment administration, as
    determined by screening ECG
    9. Received anti-tumor therapy (chemotherapy, radiotherapy, retinoid therapy, or
    hormonal therapy) within 4 weeks (less than 28 days) prior to C1D1; antibody
    therapy, molecular targeted therapy within 5 half-lives prior to C1D1.
    10. Major surgery within 4 weeks (less than 28 days) prior to C1D1
    11. Active joint inflammation or other immune disorder involving joints
    (osteoarthritis is not exclusionary)
    12. Active infection involving IV antibiotics within 2 weeks prior to C1D1
    13. Positive serology test for hepatitis B virus (HBV), hepatitis C virus (HCV), or
    active tuberculosis
    14. Positive serology test for human immunodeficiency virus (HIV) type 1 and 2, or
    known history of other immunodeficiency disease
    15. Albumin <3g/dL or total protein <6g/dL (it is not exclusionary if the patient receives albumin prophylactically)
    16. Subject has received a live vaccine within 2 weeks (less than 14 days) prior to
    C1D1
    17. Known hypersensitivity to any component of recombinant protein production by
    Chinese Hamster Ovary cells.
    18. Exposure to an investigational product or investigational device in another
    clinical study within 4 weeks (less than 28 days) prior to screening, or is
    scheduled to participate in another clinical study involving an investigational
    product or device during the course of this study
    19. Any disorder or disease, or clinically significant abnormality on laboratory or
    other clinical test(s) (eg, blood tests and ECG), that in medical judgment of the
    investigator may impede the subject’s participation in the study, pose increased
    risk to the subject, and/or confound the results of the study
    20. Subject is a family member or employee of the investigator.
    E.5 End points
    E.5.1Primary end point(s)
    Safety:

    Occurrence of DLT.

    Efficacy:

    The ratio of PuFS over puncture-free interval at baseline.

    E.5.1.1Timepoint(s) of evaluation of this end point
    Occurrance of DLT -Time of first drug related AE that occurs during 28 day period after first dose of Imalumab.

    PuFS is defined as the time from the last dose of BAX69 to the first therapeutic paracentesis after that, or death, whichever occurs first.

    Puncture-free interval at baseline is calculated as the time between the last 2 therapeutic paracenteses immediately before the first dose of BAX69.
    E.5.2Secondary end point(s)
    Efficacy:

    The ratio of time to first paracentesis post-treatment over puncture-free interval at baseline

    The change in ascites volume per unit time with treatment. The volume of ascites from the last dose of BAX69 to the first post-treatment therapeutic paracentesis per unit time will be compared to the volume of the last pre-treatment paracentesis per unit time. At each paracentesis, the volume of fluid
    that can be removed safely (measured by ultrasound-guided paracentesis) to achieve close to dryness should be withdrawn, measured, and documented.

    The changes in ascites-related symptoms (anorexia, nausea, early satiety, vomiting, abdominal pain, abdominal swelling, dyspnea, fatigue, swollen ankles, and heartburn) at baseline, weekly during the treatment period, and every 2 weeks during the Safety Follow-up period using a four-point Likert
    scale (none, mild, moderate, and severe) for self-reporting.

    Safety and Immunogenicity:

    Occurrence of serious adverse events (SAEs) and/or TEAEs, regardless of causality or relationship to study drug graded using NCI CTCAE v4.03

    Occurrence of binding and/or neutralizing anti-BAX69 antibodies following treatment with BAX69

    PK:

    BAX69 plasma PK parameters will be calculated, if estimable, using non compartmental methods and/or population PK modeling (including maximum observed concentration [Cmax], minimum observed concentration [Cmin], area under the concentration vs time curve [AUC], half-life [t1/2], apparent systemic clearance [CL/F], and volume of distribution [Vz/F])

    QoL:

    QoL will be assessed using EORTC QLQ-C30
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy:

    Time to first paracentesis post-treatment is calculated as the time between the last dose of BAX69 to subsequent first therapeutic paracentesis.

    At each paracentesis, the volume of fluid that can be removed safely (measured by ultrasound-guided paracentesis) to achieve close to dryness should be withdrawn, measured, and documented

    changes in ascites-related symptoms
    at baseline, weekly during the
    treatment period, and every 2 weeks during the Safety Follow-up period using a four-point Likert scale (none, mild, moderate, and severe) for self-reporting.





    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 Yes
    E.6.7Pharmacodynamic Yes
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Dose Escalation
    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 No
    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 No
    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.8.2.4Number 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    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
    Hungary
    Poland
    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
    LVLS
    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 months2
    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 months2
    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: 21
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 39
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 32
    F.4.2.2In the whole clinical trial 60
    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)
    If a subject is benefiting from BAX69, additional BAX69 treatment will be allowed.
    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 Decision2016-03-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-01-19
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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