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    Summary
    EudraCT Number:2017-003508-39
    Sponsor's Protocol Code Number:SMR-3475
    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:2018-01-02
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2017-003508-39
    A.3Full title of the trial
    Phase II, open label clinical study to investigate anti-tumour effect and tolerability of the PARP inhibitor 2X-121 in patients with metastatic breast cancer selected by the 2X-121 DRP®.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase II, open label clinical study to investigate anti-tumour effect and tolerability of the PARP inhibitor 2X-121 in patients with metastatic breast cancer selected by the 2X-121 DRP®.
    A.4.1Sponsor's protocol code numberSMR-3475
    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 SponsorOncology Venture Aps
    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 supportOncology Venture Aps
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHerlev og Gentofte Hospital
    B.5.2Functional name of contact pointMalgorzata Tuxen
    B.5.3 Address:
    B.5.3.1Street AddressHerlev RIngvej 75
    B.5.3.2Town/ cityHerlev
    B.5.3.3Post code2700
    B.5.3.4CountryDenmark
    B.5.4Telephone number+45Malgorzata Tuxen <malgorzata.t
    B.5.6E-mailmalgorzata.tuxen@regionh.dk
    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 name2X-121
    D.3.2Product code 2X-121
    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 INN2X-121
    D.3.9.1CAS number 1140964-99-3
    D.3.9.2Current sponsor code2X-121
    D.3.9.3Other descriptive name2X-121
    D.3.9.4EV Substance CodeSUB191066
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Metastatic Breast Cancer
    metastatisk Bryst Cancer
    E.1.1.1Medical condition in easily understood language
    Metastatic Breast Cancer
    metastatisk Bryst Cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10057654
    E.1.2Term Breast cancer female
    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
    •To evaluate the anti-tumour efficacy after treatment with 600 mg 2X-121 as single agent in a 21-days cycle in metastatic breast cancer patients selected by the 2X-121 DRP.
    E.2.2Secondary objectives of the trial
    - To evaluate progression free survival (PFS) after administration of 2X-121 in patients with mBC.
    · To evaluate duration of objective response after administration of 2X-121 in patients with mBC.
    · To evaluate overall survival (OS) after administration of 2X-121 in patients with mBC.
    · To evaluate the safety profile of 2X-121 in patients with mBC.
    · To further establish the clinical validation of the use of the 2X-121 DRP® in selection of patients with mBC treated patient
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed informed consent form.
    2. Age 18 years or older.
    3. Histologically or cytological documented mBC (independent of hormone receptor, HER2 status and BRCA1 or 2 status) relapsed on 2 or more different prior therapies.
    4. Measurable disease by CT scan or MRI.
    5. With a drug response prediction (DRP®) for 2X-121 with an outcome measured as being in the upper 10% likelihood of response.
    6. Prior chemotherapy or hormone therapy for metastatic breast cancer is allowed.
    7. Performance status of ECOG ≤ 1.
    8. Recovered to Grade <1 or baseline from prior surgery or from acute toxicities of prior radiotherapy, or from treatment with cytotoxic, hormonal or biologic agents.
    9. ≥ 2 weeks must have elapsed since any prior surgery or therapy with G-CSF and GM-CSF.
    10. Patients with intracranial disease must be on stable or decreased level of steroid therapy (e.g. dexamethasone) for at least 7 days prior to baseline MRI. Non-enzymatic inducing anti-epileptic drugs are allowed.
    11. Adequate conditions as evidenced by the following clinical laboratory values:
    a. Absolute neutrophils count (ANC) ≥ 1.5 x 109/L
    b. Haemoglobin > 4.6 mmol/L
    c. Platelets ≥ 100 x 109 /L
    d. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN*
    e. Serum bilirubin ≤ 1.5 ULN
    f. Alkaline phosphatase ≤ 3 x ULN*
    g. Creatinine ≤ 1.5 ULN
    h. Blood urea within normal limits
    12. Life expectancy equal or longer than 3 months.
    13. Sexually active females of child-producing potential must use adequate contraception (oral contraceptives, intrauterine device or barrier method of contraception) for the study duration and at least six months afterwards.
    E.4Principal exclusion criteria
    1. Concurrent chemotherapy, radiotherapy, hormonal therapy, or other investigational drug except non-disease related conditions (e.g. insulin for diabetes) during study period.
    2. Previous treatment with PARP inhibitors.
    3. Other malignancy with exception of curative treated non-melanoma skin cancer or cervical carcinoma in situ within 5 years prior to entering the study.
    4. Any active infection requiring parenteral or oral antibiotic treatment.
    5. Known HIV positivity.
    6. Known active hepatitis B or C.
    7. Clinical significant (i.e. active) cardiovascular disease:
    a. Stroke within ≤ 6 months prior to day 1
    b. Transient ischemic attach (TIA) within ≤ 6 months prior to day 1
    c. Myocardial infarction within ≤ 6 months prior to day 1
    d. Unstable angina
    e. New York Hart Association (NYHA) Class II or greater congestive heart failure (CHF)
    f. Serious cardiac arrhythmia requiring medication
    8. Other medications or conditions, including surgery, that in the Investigator’s opinion would contraindicate study participation for safety reasons or interfere with the interpretation of study results.
    9. Inability to take oral medication, or malabsorption syndrome or any other uncontrolled gastrointestinal condition (e.g., nausea, diarrhea, or vomiting) that might impair the bioavailability of 2X-121.
    10. Requiring immediate palliative treatment of any kind including surgery and/or radiotherapy.
    11. Female patients who are pregnant or breast-feeding (pregnancy test with a positive result before study entry).
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is clinical benefit rate (CBR) defined as complete response (CR), partial response (PR) or stable disease (SD) > 24
    weeks using the RECIST criteria version 1.1.
    E.5.1.1Timepoint(s) of evaluation of this end point
    · All patients who received at least 2 treatment cycles will be considered evaluable for response.
    · Patients discontinuing early due to disease progression will also be evaluable for response.
    E.5.2Secondary end point(s)
    · Progression free survival
    · Duration of response (from first response to progression).
    · Overall survival.
    E.5.2.1Timepoint(s) of evaluation of this end point
    · All patients who received at least 2 treatment cycles will be considered evaluable for response.
    · Patients discontinuing early due to disease progression will also be evaluable for response.
    - All patiients having received atleast one dosage of IMP will be evaluable for safety
    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 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 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.8.3 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 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 days
    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: 16
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 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 state26
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 26
    F.4.2.2In the whole clinical trial 26
    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 Decision2018-02-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-02-12
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2020-06-24
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