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    Summary
    EudraCT Number:2013-000931-28
    Sponsor's Protocol Code Number:GEXMab25201
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2013-06-28
    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 ConcernedUK - MHRA
    A.2EudraCT number2013-000931-28
    A.3Full title of the trial
    A Double-blind, Placebo-controlled, Randomized, Phase 2 Study to Evaluate the Efficacy and Safety of Maintenance Therapy With PankoMab-GEX™ After Chemotherapy in Patients With Recurrent Epithelial Ovarian Carcinoma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to evaluate the efficacy and safety of maintenance therapy with PankoMab-GEX™ after chemotherapy in patients with recurrent epithelial ovarian carcinoma.
    A.4.1Sponsor's protocol code numberGEXMab25201
    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 SponsorGlycotope GmbH
    B.1.3.4CountryGermany
    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 supportGlycotope GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlycotope GmbH
    B.5.2Functional name of contact pointJoanna Raszewska, S. Med. Director
    B.5.3 Address:
    B.5.3.1Street AddressRobert-Roessle-Str. 10
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code13125
    B.5.3.4CountryGermany
    B.5.4Telephone number49309489 2652
    B.5.5Fax number49309489 2612
    B.5.6E-mailjoanna.raszewska@glycotope.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 namePankoMab-GEX
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous drip use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNA
    D.3.9.3Other descriptive namePANKOMAB-GEX
    D.3.9.4EV Substance CodeSUB31981
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number500 to 1700
    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 placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous drip use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Recurrent Epithelial Ovarian, Fallopian Tube or Primary High Grade Peritoneal Carcinoma.
    E.1.1.1Medical condition in easily understood language
    Recurrent Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10016180
    E.1.2Term Fallopian tube cancer
    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 19.0
    E.1.2Level LLT
    E.1.2Classification code 10052171
    E.1.2Term Peritoneal carcinoma
    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 19.0
    E.1.2Level PT
    E.1.2Classification code 10066697
    E.1.2Term Ovarian cancer recurrent
    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
    The primary study objective is:
    To evaluate the efficacy of maintenance therapy with single-agent PankoMab-GEX™ compared to placebo as assessed by progression free survival (PFS) following chemotherapy in patients with recurrent epithelial ovarian, fallopian tube or primary high grade peritoneal carcinoma
    E.2.2Secondary objectives of the trial
    The secondary study objectives are:
    - To evaluate the efficacy of PankoMab-GEX™ compared to placebo as assessed by patient survival and tumor response related criteria/parameters.
    - To evaluate the safety of maintenance therapy with single-agent PankoMab-GEX™ compared to placebo.
    - To evaluate the quality of life (QoL) and other health and health-economy related outcomes.
    - To evaluate potential efficacy and safety correlations of the tumor-specific epitope TA-MUC1 immuno-histochemical (IHC) score in the tumor tissue samples, soluble TA-MUC1 serum levels, serum pharmacokinetic (PK), pharmacodynamic (PD), genotyping regarding Fcγ receptor status and potentially disease- or pathway-related parameters during maintenance therapy with single-agent PankoMab-GEX™ or placebo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Female patients over or equal to 18 years of age.
    2. Histologically-confirmed, TA-MUC1 positive, recurrent epithelial ovarian or fallopian-tube cancer or primary peritoneal cancer with high-grade (grade 2 or 3) serous features or a serous componentovarian carcinoma.
    3. Availability of tumor tissue samples (slices or block) for immune-histological confirmation of TA-MUC1 status (tissue samples may also be stored for other further specified biomarker assessments).
    4. Patients should have received at least 2 lines but not more than 5 lines of chemotherapy prior to start of maintenance treatment. NOTE: Neo-Adjuvant lines will not count as previous lines of treatment.
    5. Documented response to or stable disease following the most recent line of chemotherapy (any regimen and duration in accordance with local or international guidelines or within independent ethics committee [IEC] approved studies) and received last dose of said chemotherapy maximum 6 weeks prior to randomization (response to prior chemotherapy is defined as a partial/complete response according to radiological response criteria and/or a confirmed decline in tumor marker CA125 ≥50% from the pretreatment value ≥2 × the upper limit of normal [ULN]; stable disease is defined as stable disease according to radiological response criteria with a confirmed lack of increase in tumor marker CA125 from the pretreatment value for patients who have a pretreatment value ≥2 × ULN and no clinical progression). CA125 prior to randomization must be below ULN or CA125 levels must not increase >15% within a time frame >7 days if above ULN.
    6. Progression-free interval of maximum12 months immediately preceding the chemotherapy to which the patient has just responded.
    7. Sensitive or resistant to the most recent platinum-based chemotherapy preceding the chemotherapy to which the patient has just responded (sensitive is thereby defined as a recurrence of disease >6 to ≤12 months after end of platinum-based chemotherapy and resistant is defined as a recurrence of disease ≤6 months after the end of platinum-based chemotherapy).
    8. ECOG performance status ≤1.
    9. Recovered from all chemotherapy-related toxicities to grade 1 or grade 0 according to the NCI CTCAE version 4.0, with the exception of alopecia (any grade) and peripheral neuropathy (≤grade 2).
    10. Adequate bone marrow and hepatic function at Screening:
    •Hemoglobin over or equal to 9 g/dL
    •White blood cell count over or equal to 3.0 × 109/L
    •Absolute neutrophil count over or equal to 1.5 × 109/L
    •Platelet count over or equal to 100 × 109/L
    •Aspartate aminotransferase and alanine aminotransferase <3 × ULN (<5 × ULN in case of liver metastases)
    •Bilirubin <1.5 × ULN (<3 × ULN in case of liver metastases)
    •Creatinine <1.5 × ULN.
    11. Any patient with childbearing potential (i.e., not surgically sterile or postmenopausal for >1 year) must use highly effective contraceptives with a Pearl index <1% according to the Note for guidance on non-clinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals (CPMP/ICH/286/95) of the European Medicines Agency (EMA) (Note: although pregnancy is unlikely to occur in this patient population, any patient with childbearing potential will be withdrawn from the study in the event of pregnancy).
    12. Life expectancy >3 months.
    13. Ability and willingness to give written informed consent.
    E.4Principal exclusion criteria
    1. Refractory to platinum-based chemotherapy (defined as remained progressive or became progressive under any previous platinum-based regimen).
    2. Progression-free interval of >12 months after the most recent antecedent platinum-based chemotherapy regimen.
    3. Concomitant anti-tumor therapy or immunotherapy.
    4. Treatment with monoclonal antibodies or investigational agents maximum 30 days before randomization (Note: prior anti-MUC1 therapy is not permitted at any time).
    5. Limited field radiotherapy maximum 30 days before randomization (Note: extensive prior radiotherapy during or following the last line of chemotherapy is not permitted; radiotherapy prior to the last line of chemotherapy is permitted).
    6. Prior allergic reaction to a monoclonal antibody, grade 3 IRR or any grade 4 reaction to a monoclonal antibody.
    7. Known sensitivity to any component of the test product.
    8. Contraindication to the premedication used in this study (paracetamol/acetaminophen, H1 and/or H2 receptor antagonists, and steroids).
    9. Clinical evidence of brain metastasis or leptomeningeal involvement.
    10. Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, Ductal Carcinoma in Situ (DCIS), stage 1 grade 1 endometrial carcinoma, or other solid tumors including lymphomas (without bone marrow involvement) curatively treated with no evidence of disease for ≥ 5 years.
    11. Primary or secondary immune deficiency.
    12. Clinically active infections >grade 2 using NCI CTCAE v 4.0.
    13. Active hepatitis B or C or infection with human immunodeficiency virus (HIV).
    14. Myocardial infarction within 6 months prior to Screening.
    15. Symptomatic congestive heart failure (New York Heart Association grade 3 or 4), unstable angina pectoris within 6 months prior to Screening, significant cardiac arrhythmia or history of stroke or transient ischemic attack within 1 year prior to Screening.
    16. Prior or planned major surgery within 30 days prior to randomization and/or incomplete recovery from prior surgery.
    17. Concomitant use of systemic steroids, except for inhaled, topical or nasal application within 30 days prior to randomization (Note: steroids used for premedication are permitted).
    18. Active drug or alcohol abuse.
    19. Any uncontrolled medical condition that may put the patient at high risk during treatment with an investigational drug, including unstable diabetes mellitus, vena cava syndrome, or chronic symptomatic respiratory disease.
    20. Pregnancy or lactation.
    21. Legal incompetence, limited legal competence, or detainment in an institution for official or legal reasons.
    Receipt of any other investigational medicinal product within the last 30 days before randomization or any previous PankoMab-GEXTM administration.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is PFS, as assessed by the site investigator and defined as the time interval from the date of randomization to the first date of documented disease progression using immune related response criteria based on modified RECIST version 1.1 (irRC) or death due to any cause.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Weeks 8, 14, 20, followed by 8-weekly exams for the first year and 12-weekly exams thereafter
    E.5.2Secondary end point(s)
    Secondary efficacy endpoints are as follows:
    • PFS, as assessed by independent central review (irRC and RECIST 1.1).
    • PFS according to Gynecologic Cancer Intergroup (GCIG) criteria, based on central laboratory data.
    • The PFS rate at 6 months, as assessed on site (irRC) and by independent central review (irRC, RECIST 1.1, and GCIG criteria).
    • Objective response rate (ORR), as assessed on site (irRC) and by independent central review (irRC, RECIST 1.1, and GCIG criteria).
    • CBR, as assessed on site (irRC) and by independent central review (irRC, RECIST 1.1, and (GCIG criteria)).
    • Overall survival (OS).
    • QoL scores as assessed by European Oncology Research Trials Committee (EORTC) QoL questionnaires EORTC-QLQ-C30 and EORTC-QLQ-OV28 (according to availability of validated translations).
    • Relationship of TA-MUC1-IHC score in the tumor tissue samples, soluble TA-MUC1 serum levels and FCγ receptor status to activity parameters.
    • Relationship of pharmacodynamics variables CA125 and HE4 to activity parameters.
    • Relationship of stratification factors to activity parameters.
    • PK analyses.
    • Immunogenicity: incidence of anti-drug antibodies (ADAs).
    • Overall tolerability (standard safety assessments in terms of laboratory evaluations, vital signs, electrocardiogram [ECG], and physical examinations).
    • Incidence and severity of adverse events (AEs) and IRRs.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy endpoint:Weeks 8, 14, 20, followed by 8-weekly exams for the first year and 12-weekly exams thereafter.
    All other endpoints: 3-weekly.
    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 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) 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 Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Open-label phase after the primary analysis.
    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 concerned42
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA42
    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
    Germany
    Hungary
    Italy
    Poland
    Romania
    Russian Federation
    Spain
    United Kingdom
    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 years3
    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 years3
    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: 63
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 147
    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 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 Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state42
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 161
    F.4.2.2In the whole clinical trial 210
    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)
    None
    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 Decision2013-06-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-09-06
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2017-07-28
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