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    Summary
    EudraCT Number:2013-003469-32
    Sponsor's Protocol Code Number:UCL/13/0045
    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:2014-08-18
    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 number2013-003469-32
    A.3Full title of the trial
    A Single Arm Phase II trial of BMN 673 for inoperable, advanced endometrial cancer with retrospective PTEN, MSI and MRE11 analysis.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A PARP inhibitor for inoperable, advanced endometrial cancer (PANDA).
    A.3.2Name or abbreviated title of the trial where available
    PANDA
    A.4.1Sponsor's protocol code numberUCL/13/0045
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02127151
    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 SponsorUniversity College London
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportCancer Research UK
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportBioMarin Pharmaceutical Inc
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity College London
    B.5.2Functional name of contact pointLee Webber
    B.5.3 Address:
    B.5.3.1Street AddressCancer Research UK and UCL Cancer Trials Centre, 5th Floor, 90 Tottenham Court Road
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeW1T 4TJ
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number02076799872
    B.5.5Fax number02076799871
    B.5.6E-mailctc.panda@ucl.ac.uk
    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 nameBMN 673
    D.3.2Product code N/A
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBMN 673fb
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codeBMN 673ts
    D.3.9.3Other descriptive nameN/A
    D.3.9.4EV Substance CodeAS3
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Inoperable, advanced, recurrent or metastatic endometrial cancer
    E.1.1.1Medical condition in easily understood language
    Cancer of the womb which has spread to other organs and cannot be treated by surgery
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10014733
    E.1.2Term Endometrial cancer
    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 main aim of this trial is to show whether or not BMN 673 has therapeutic benefit in the treatment of inoperable, advanced, recurrent or metastatic endometrial cancer; specifically whether the drug extends the progression free survival of patients i.e. the length of time during and after the treatment that the patient lives with the cancer but it does not get significantly worse. This will be measured by looking at how many patients of the recruited patients are alive and progression free 6 months after their first dose of BMN 673.
    E.2.2Secondary objectives of the trial
    - To examine whether the use of BMN 673 in the selected patient population is safe and tolerable in terms of side effects, or 'adverse events';
    - To examine whether the use of BMN 673 in the selected patient population improves survival rates;
    - To further examine, as in the principal research question, other response rates associated with the use of BMN 673;
    - To look at whether certain biological characteristics of advanced endometrial cancers can be used to predict whether patients are likely to derive benefit from being treated with drugs such as BMN 673;
    - Similarly, whether a patient's prior history of treatment with platinum-based chemotherapy can be used to predict whether patients are likely to derive benefit from being treated with drugs such as BMN 673.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    PANDA Translational Research v1.0 21jul14
    E.3Principal inclusion criteria
    - Age ≥ 18 years
    - Histologically confirmed endometrial cancer. All histological subtypes except for carcinosarcoma are eligible
    - Evidence of inoperable, advanced, recurrent or metastatic disease by imaging and/or histological criteria
    - ≤ 1 previous line of systemic cancer therapy for inoperable, advanced, recurrent or metastatic endometrial cancer. Chemotherapy in the adjuvant setting is not considered a prior line of therapy unless recurrence occurred during adjuvant treatment or within 6 months of the last treatment; first line treatment of advanced disease must include at least one cytotoxic agent to be considered as a line of therapy; prior hormonal treatment is not considered a line of therapy in any setting
    - Written informed consent obtained prior to any screening procedures
    - Patients must give consent for analysis of archived histological diagnostic tissue for immunohistochemistry (IHC). If archived tissue is not available or is of insufficient quantity or quality, the patient will have the option to undergo biopsy if feasible. If biopsy is not feasible or the patient does not give consent for biopsy when archived tissue is not available, the patient will not be eligible for the trial. The quality and quantity of archived tissue will be assessed by a suitably qualified individual, usually a histopathologist, at site to ensure adequate tissue sample available for testing for PTEN, MSI and MRE11
    - Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-2
    - Life expectancy > 12 weeks
    - Patient has at least one site of measurable disease (i.e. target lesion) per RECIST v1.1
    - Evidence of non-childbearing status and must not be lactating OR must have postmenopausal status
    - Adequate bone marrow and organ function
    E.4Principal exclusion criteria
    - Prior treatment with a PARP inhibitor
    - Progressive disease ≤3 months after platinum-based chemotherapy
    - Active uncontrolled infection including known Hepatitis B, Hepatitis C or HIV
    - Obstruction of the gastrointestinal tract or other reason preventing effective oral administration of medication
    - Serious concomitant non-malignant disease, uncontrolled organ dysfunction or medical disorder considered by the Investigator to make the subject unsuitable for trial participation including any psychiatric disorder that prevents informed consent
    - Significant active cardiovascular disease
    - Symptomatic brain metastases
    - Immunosuppressant therapy or considered to be otherwise immunocompromised
    - Myelodysplastic syndrome/acute myeloid leukaemia
    - Major surgery within 4 weeks of registration or ongoing clinically significant post-surgical complications
    - Chemotherapy, radiotherapy (a single fraction of palliative radiotherapy is allowed provided that the site being treated is not subsequently used as a target lesion as per RECIST v1.1 for the purpose of assessing tumour response on trial), immunotherapy or other investigational therapy for cancer within 21 days of registration (42 days for nitrosoureas, mitomycin-C)
    - Unresolved clinically significant toxicities from prior systemic therapy
    - Known hypersensitivity to any of the agents or excipients to be administered
    - Unwillingness or inability to comply with the trial protocol
    - History of other malignancy within 3 years of registration, except for:
    o Cone-biopsied in situ carcinoma of the cervix uteri
    o Basal or squamous cell carcinoma of the skin
    E.5 End points
    E.5.1Primary end point(s)
    Progression free survival (PFS) rate at 6 months measured by RECIST v1.1.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months from first BMN 673 dose.
    E.5.2Secondary end point(s)
    - Best Response, where response is complete response (CR) or partial response(PR) assessed by RECIST v1.1
    - Response at each radiological assessment
    - Duration of Response
    - Overall Survival
    - Median Progression Free Survival
    - Safety and Toxicity: CTCAE v4.03 ≥ grade 3 toxicity, dose reductions and interruptions, exposure and compliance

    - Exploratory endpoints including PTEN, MSI, MRE11 and platinum-free interval as response modifiers
    E.5.2.1Timepoint(s) of evaluation of this end point
    - As per radiological imaging timepoints specified by protocol, following baseline and first BMN 673 dose
    - As per radiological imaging timepoints specified by protocol, following baseline and first BMN 673 dose
    - As per radiological imaging timepoints specified by protocol, following baseline and first BMN 673 dose
    - Variable, measured from first BMN 673 dose
    - From first BMN 673 dose to first progression as per RECIST v1.1 and/or death
    - Cycle 1 (days 1 i.e. first BMN 673 dose, 8, 15, 22), Cycle 2 Day 1 (incremental day 29), once every cycle thereafter (day 1 only), end of study visit

    - Screening, cycle 1 (days 1 & 15), cycle 2 (day 1 ± 3 days) on response and progression as per RECIST v1.1 (where applicable)
    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 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) 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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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 trial1
    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 concerned13
    E.8.5The trial involves multiple Member States No
    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 No
    E.8.7Trial has a data monitoring committee No
    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 months7
    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 months7
    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.1.2.1Number of subjects for this age range: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state100
    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)
    The sponsor and BioMarin Pharmaceutical Inc have agreed that there may be continued provision of BMN 673 for patients who derive continued benefit (i.e. ongoing radiological response) from the treatment at such a time that the trial needs to be closed for final analysis of data. The Trial Management Group would need to agree this. Patients who have been previously withdrawn from taking BMN 673 during the research will not be allowed to restart the drug off study.

    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-09-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-10-13
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2015-12-09
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