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    Summary
    EudraCT Number:2011-001119-30
    Sponsor's Protocol Code Number:2B3-101-CR-001
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-04-12
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2011-001119-30
    A.3Full title of the trial
    An open-label, Phase I/IIa, dose escalating study of 2B3-101 in patients with solid tumors and brain metastases or recurrent malignant glioma.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An open-label, early stage, dose rising study of 2B3-101 in patients with solid tumors and brain metastases or recurrent malignant glioma.
    A.3.2Name or abbreviated title of the trial where available
    2B3-101-CR-001
    A.4.1Sponsor's protocol code number2B3-101-CR-001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01386580
    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 Sponsorto-BBB technologies B.V.
    B.1.3.4CountryNetherlands
    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 supportto-BBB technologies B.V.
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSMS-oncology
    B.5.2Functional name of contact pointProject Manager
    B.5.3 Address:
    B.5.3.1Street AddressScience Park 406
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1098 XH
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31020 435 0580
    B.5.5Fax number+31020 435 0589
    B.5.6E-maile.schipper@sms-oncology.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 name2B3-101
    D.3.2Product code 2B3-101
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDOXORUBICIN HYDROCHLORIDE
    D.3.9.1CAS number 25316-40-9
    D.3.9.4EV Substance CodeSUB01827MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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.IMP: 2
    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 Yes
    D.2.1.1.1Trade name Herceptin
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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.3.4Pharmaceutical form Powder for concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTRASTUZUMAB
    D.3.9.1CAS number 180288-69-1
    D.3.9.4EV Substance CodeSUB12612MIG
    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 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
    Solid tumors and brain metastases or recurrent malignant glioma, HER2-positive adenocarcinoma of the breast with brain metastases
    E.1.1.1Medical condition in easily understood language
    - solid tumors and brain metastases or recurrent malignant glioma.
    - HER2-positive adenocarcinoma of the breast with brain metastases
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10065147
    E.1.2Term Malignant solid tumor
    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 14.1
    E.1.2Level LLT
    E.1.2Classification code 10065252
    E.1.2Term Solid tumor
    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 14.1
    E.1.2Level PT
    E.1.2Classification code 10065443
    E.1.2Term Malignant glioma
    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 14.1
    E.1.2Level LLT
    E.1.2Classification code 10027475
    E.1.2Term Metastatic breast 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 14.1
    E.1.2Level LLT
    E.1.2Classification code 10006128
    E.1.2Term Brain metastases
    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 assess the safety and tolerability of 2B3-101 when administered intravenously (IV) as single agent in patients with solid tumors and brain metastases or recurrent malignant glioma in order to determine the Maximum Tolerated Dose (MTD).
    E.2.2Secondary objectives of the trial
    •Characterize the PK of 2B3-101 after multiple i.v. infusions as single agent and in combination with trastuzumab;
    •Evaluate the preliminary efficacy of 2B3-101 as single agent in terms of anti-tumor activity in patients with breast cancer with treated or untreated brain metastases.
    •Evaluate the preliminary efficacy of 2B3-101 as single agent in terms of anti-tumor activity in patients with other solid tumors with treated or untreated brain metastases, treated in the dose-escalation phase.
    •Evaluate the preliminary antitumor activity of 2B3-101 in combination with trastuzumab in patients with HER2+ breast cancer with treated or untreated brain metastases.
    •Evaluate the preliminary anti-tumor activity of 2B3-101 as single agent in patients with small cell lung cancer (SCLC) or melanomas with treated or untreated brain metastases.
    •To evaluate the preliminary efficacy of 2B3-101 in terms of anti-tumor activity as single agent in patients with recurrent malignant glioma.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    To be eligible to participate in this study, candidates must meet the following eligibility criteria:
    1. Age ≥ 18 years.
    2. Measurable intracranial disease by MRI.
    3. ECOG Performance Status ≤ 2.
    4. Estimated life expectancy of at least 8 weeks.
    5. Toxicities incurred as a result of previous anticancer therapy (radiation therapy, chemotherapy, or surgery) must be resolved to ≤ grade 2 (as defined by CTCAE version 4.0).
    6. No evidence of (cortical) cognitive impairment as defined by a Mini-Mental Status Exam (MMSE) score ≥ 25/30.
    7. Written informed consent according to local guidelines.

    In addition to the above listed eligibility criteria, the following criteria are applicable:
    8. 2B3-101 single agent dose-escalation phase:
    Patients with pathologically confirmed diagnosis of advanced, recurrent solid tumors and unequivocal evidence of brain metastases that are refractory to standard therapy or for whom no standard therapy exists or with unequivocal evidence of newly diagnosed untreated brain metastases and controlled extracranial disease.

    OR

    Patients with pathology confirmed diagnosis of advanced, recurrent primary malignant (grade III and IV) glioma that are refractory to standard therapy or for whom no standard therapy exists.

    2B3-101 in combination with trastuzumab dose-escalation phase:
    Patients with histologically-confirmed HER2-positive adenocarcinoma of the breast with unequivocal evidence of brain metastases that are refractory to standard therapy or for which no standard therapy exist or with unequivocal evidence of newly diagnosed untreated brain metastases and controlled extracranial disease.

    Breast cancer brain metastases study- arm of the expansion phase:
    Patients with pathologically confirmed diagnosis of advanced, recurrent breast cancer with unequivocal evidence of brain metastases that are refractory to standard therapy or for whom no standard therapy exist.

    OR

    Patients with pathologically confirmed diagnosis of advanced breast cancer with newly diagnosed, untreated, brain metastases, which per multi-disciplinary team decision do not require immediate radiotherapy or surgery.

    Patients with histologically-confirmed HER2-positive adenocarcinoma of the breast with unequivocal evidence of brain metastases that are refractory to standard therapy or for which no standard therapy exist or with unequivocal evidence of newly diagnosed untreated brain metastases, which per the multi-disciplinary team decision do not require immediate radiotherapy or surgery

    SCLC brain metastases study arm of the expansion phase:
    Patients with pathologically confirmed diagnosis of advanced, recurrent SCLC with unequivocal evidence of brain metastases that are refractory to standard therapy or for whom no standard therapy exist.

    OR

    Patients with pathologically confirmed diagnosis of advanced SCLC with newly diagnosed, untreated, brain metastases, which per multi-disciplinary team decision do not require immediate radiotherapy or surgery.

    Melanoma brain metastases study arm of the expansion phase:
    - Patients with pathologically confirmed diagnosis of advanced, recurrent melanoma with unequivocal evidence of brain metastases that are refractory to standard therapy or for whom no standard therapy exist.

    OR

    Patients with pathologically confirmed diagnosis of advanced mel;anoma with newly diagnosed, untreated, brain metastases, which per multi-disciplinary team decision do not require immediate radiotherapy or surgery.


    Recurrent malignant glioma study- arm of the expansion phase:
    -7 patients with histologically proven glioma grade IV, which is progressive following first line treatment with surgery or biopsy followed by fractionated radiotherapy with concurrent temozolomide-containing chemotherapy.
    -7 patients with histologically confirmed recurrent malignant (WHO grade III and IV) glioma or histologically confirmed low-grade (WHO grade II) glioma with radiographic evidence of malignant transformation by MRI, that are refractory to standard therapy, or for whom no standard therapy exists or do not require immediate standard therapy per the multi-disciplinary team decision.

    E.4Principal exclusion criteria
    Candidates will be excluded from study entry if any of the following exclusion criteria exist:

    Prior Treatment:
    1. Less than 1 week since the last treatment of lapatinib, less than 2 weeks since the last treatment of vemurafenib, less than 4 weeks since the last treatment of chemotherapy, biological therapy, immunotherapy and systemicradiotherapy (except palliative radiation delivered to <20% of bone marrow), less than 6 weeks for nitrosoureas and mitomycin C and less than 8 weeks for cranial radiotherapy. Previous trastuzumab treatment will be allowed to continue without interruption in patients that are included in either the 2B3-101 dose-escalation phase in combination with trastuzumab or in the breast cancer expansion phase once the MTD for the combination has been established.
    2. Patients that have received a maximum cumulative dose of free (i.e., non-liposomal) or liposomal doxorubicin > 360mg/m2 or free epirubicin > 600mg/m2

    Current Treatment:
    3. Current or recent (within 30 days of first study treatment) treatment with another investigational drug or participation in another investigational study.

    Hematology, coagulation and biochemistry:
    4. Inadequate bone marrow function: Absolute Neutrophil Count (ANC): < 1.5 x 109/L, or platelet count < 100 x 109/L or hemoglobin < 6 mmol/L.
    5. Inadequate liver function, defined as:
    • Serum (total) bilirubin > 1.5 x the ULN for the institution if no liver metastases (> 2 x ULN in patients with liver metastases);
    • ASAT or ALAT > 2.5 x ULN if no liver metastases (> 4 x ULN in patients with liver metastases);
    • Alkaline phosphatase levels > 2.5 x ULN if no liver metastases (> 5 x ULN in patients with liver metastases, or > 10 x ULN in patients with bone metastases).
    6. Inadequate renal function, defined as:
    • Serum creatinine > 1.5 x ULN.

    Other:
    7. Leptomeningeal carcinomatosis as the only site of CNS involvement.
    8. Pregnancy or lactation. Serum pregnancy test to be performed within 7 days prior to study treatment start, or within 14 days followed by a confirmatory urine pregnancy test within 7 days prior to study treatment start.
    9. For female subjects of childbearing potential (defined as < 2 years after last menstruation and not surgically sterile) and male subjects who are not surgically sterile or with female partners of childbearing potential: absence of effective, non-hormonal means of contraception (intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal gel).
    10. Major surgical procedure (including open biopsy, excluding central line IV and portacath) within 28 days prior to the first study treatment, or anticipation of the need for major surgery during the course of the study treatment.
    11. Grade 3 or 4 motor, sensory, or cranial neuropathy symptoms (as defined by CTCAE version 4.0).
    12. Uncontrolled hypertension (systolic > 150 mm Hg and/or diastolic > 100mm Hg).
    13. Clinically significant (i.e. active) cardiovascular disease defined as:
    • Stroke within ≤ 6 months prior to day 1;
    • Transient Ischemic Attack (TIA) within ≤ 6 months prior to day 1;
    • Myocardial infarction within ≤ 6 months prior to day 1;
    • Unstable angina;
    • New York Heart Association (NYHA) Grade II or greater Congestive Heart Failure (CHF);
    • Serious cardiac arrhythmia requiring medication;
    • Clinically relevant pathologic findings in ECG.
    14. 14. Left Ventricle Ejection Fraction (LVEF) by MUGA or ECHO < 55% for patients receiving 2B3-101 in combination with trastuzumab. For patients receiving single agent 2B3-101 treatment. Left Ventricle Ejection Fraction (LVEF) by MUGA or ECHO < 50%
    15. Known hypersensitivity to any of the study drug components or excipients (e.g. doxorubicin, PEG or GSH).
    16. Evidence of any other medical conditions (such as psychiatric illness, infectious diseases, physical examination or laboratory findings) that may interfere with the planned treatment, affect patient compliance or place the patient at high risk from treatment-related complications.
    E.5 End points
    E.5.1Primary end point(s)
    The incidence rate of DLTs duringin the DLT observation period (cycle 1) at each 2B3-101 dose level is based on predefined safety parameters in order to and will determine the MTD of 2B3-101 as single agent and in combination with trastuzumab, respectively. These safety parameters are: Adverse drug reactions (ADR) and serious ADRs, changes in hematology and chemistry values, including those associated with hepatic and renal function, and assessment of physical examinations, vital signs and cardiac function (i.e. repeated electrocardiograms). Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be used.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The dose limiting toxicity (DLT) observation period for a dose level will be cycle 1 (day 1 to day 21).
    E.5.2Secondary end point(s)
    - Pharmacokinetics of 2B3-101 as single agent in plasma; Cmax, Vss, T1/2, AUC, CL;
    - Pharmacokinetics of 2B3-101 when combined with trastuzumab in plasma; Cmax, Vss, T1/2, AUC, CL;
    - Preliminary efficacy: Antitumor effects of 2B3-101 as single agent and when combined with trastuzumab according to RECIST 1.1 (solid tumors) and RANO (malignant gliomas).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Blood samples will be taken on day 1, 2, 3, 5, 8 and 11 of cycle 1 and day 1, 8 and 15 of cycle 2 and on day 1 of cycle 3 and 4 to assess the PK profile during the first 4 cycles.

    Preliminary clinical efficacy of 2B3-101 will be measured by CT/MRI-scan on the last day of every even cycle (cycle 2, 4, etc.). A bone scan should only be obtained if clinically indicated and is to be performed as needed during the study if the patient develops symptoms or signs of bone disease. If bone metastases are present at screening, bone scans during treatment should be performed in addition to and at the same time as the CT/MRI-scans.
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 Yes
    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 trial6
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA8
    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
    United States
    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 months6
    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 months6
    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.1.1.2Preterm 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: 82
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    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 state45
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 82
    F.4.2.2In the whole clinical trial 82
    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)
    A patient will stay on treatment until disease progression, unacceptable toxicity, or discontinuation for any other reason. After this term the patient will be able to receive other experimental treatment(s).
    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 Decision2011-04-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-06-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-09-25
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