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    Summary
    EudraCT Number:2020-000301-87
    Sponsor's Protocol Code Number:RP-3500-01
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-08-11
    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 number2020-000301-87
    A.3Full title of the trial
    Phase 1/2a Study of the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Clinical Activity of RP-3500 Alone or in Combination with Talazoparib or Gemcitabine in Advanced Solid Tumors with ATR inhibitor Sensitizing Mutations (TRESR Study)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase 1/2a trial to study how safe and tolerable RP-3500 is when administered along or in combination with talazoparib or gemcitabine in patients with certain types of cancer
    A.3.2Name or abbreviated title of the trial where available
    TRESR Study
    A.4.1Sponsor's protocol code numberRP-3500-01
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04497116
    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 SponsorRepare Therapeutics
    B.1.3.4CountryCanada
    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 supportRepare Therapeutics
    B.4.2CountryCanada
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRepare Therapeutics
    B.5.2Functional name of contact pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street Address101 Main Street, 16th Floor, Suite 1650
    B.5.3.2Town/ cityCambridge, MA
    B.5.3.3Post code02142
    B.5.3.4CountryUnited States
    B.5.4Telephone number0019782898488
    B.5.6E-mailclinical@reparerx.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 nameRP-3500
    D.3.2Product code RP-3500
    D.3.4Pharmaceutical form Capsule, hard
    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 INNTo be determined
    D.3.9.1CAS number 2417489-10-0
    D.3.9.2Current sponsor codeRP-3500
    D.3.9.3Other descriptive nameRP-3500 hydrogen sulfate salt
    D.3.9.4EV Substance CodeSUB219085
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number5 to 40
    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 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 nameTalzenna
    D.3.2Product code MDV3800, BMN 673
    D.3.4Pharmaceutical form Capsule, hard
    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 INNTALAZOPARIB
    D.3.9.1CAS number 1373431-65-2
    D.3.9.2Current sponsor codeTalazoparib
    D.3.9.4EV Substance CodeSUB180394
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.25
    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: 3
    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 Gemcitabine
    D.2.1.1.2Name of the Marketing Authorisation holderPL 11204/0216
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameGemcitabine
    D.3.4Pharmaceutical form 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 INNGEMCITABINE
    D.3.9.1CAS number 95058-81-4
    D.3.9.4EV Substance CodeSUB07892MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number38
    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
    Advanced/recurrent solid tumors which have ATRi sensitizing biomarkers
    E.1.1.1Medical condition in easily understood language
    To treat various cancer types that have specific genes expected to be sensitive to the study medication.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10065252
    E.1.2Term Solid tumor
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Module 1: assess the safety and tolerability of RP-3500 in patients with eligible advanced solid tumors ; define the MTD of RP-3500 monotherapy, and determine a recommended phase 2 dose (RP2D) and schedule
    Module 2: assess anti-tumor activity of RP-3500 when administered to eligible patients at the RP2D and schedule in selected genetic backgrounds
    Module 3: assess the safety and tolerability of RP-3500 and talazoparib combination in eligible patients with advanced solid tumors ; define the MTD of RP-3500 and talazoparib combination and determine RP2D and schedule
    Module 4: assess the safety and tolerability of RP-3500 and gemcitabine combination in eligible patients with advanced solid tumors ; define the MTD of RP-3500 and gemcitabine combination and determine RP2D and schedule
    E.2.2Secondary objectives of the trial
    Module 1: assess preliminary anti-tumor activity with RP-3500, characterize the PK profile of RP-3500, assess PK parameters of RP-3500 monotherapy in fasted and fed states, asess the relationship between PD biomarkers and PK of RP-3500 to aid in schedule decisions and assess correlation with clinical outcomes
    Module 2: assess anti-tumor activity of RP-3500 when administered to eligible patients at the P2D* and schedule evaluated in the arms
    Module 3: assess preliminary anti-tumor activity of RP-3500 and talazoparib combination in eligible patients, assess any PK interaction of RP-3500 and talazoparib combination, determine the PK/PD relationships of RP-3500 and talazoparib combination to confirm dose/schedule
    Module 4: assess preliminary anti-tumor activity of RP-3500 and gemcitabine combination in eligible patients with advanced solid tumors, assess the PK of RP-3500 when administered in combination with gemcitabine
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Title: Phase 1/2a Study of the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Clinical Activity of RP-3500 Alone or in Combination with Talazoparib or Gemcitabine in Advanced Solid Tumors with ATR
    inhibitor Sensitizing Mutations (TRESR Study)
    Version 3.0 dated 22 February 2022
    Objective: To investigate the mechanisms of treatment-emergent anemia in patients treated with RP-3500
    E.3Principal inclusion criteria
    Main criteria are the following ones (additional criteria can exist, depending on the module):
    1. Written informed consent, according to local guidelines, signed and dated by the patient or legal guardian prior to the performance of any study-specific procedures, sampling, or analyses.
    2. Male or female and ≥18 years-of-age at the time of signature of the ICF.
    3. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
    4. Histologically confirmed solid tumors resistant or refractory to standard treatment and/or patients who are intolerant to standard therapy.
    5. Measurable disease as per RECIST v1.1
    6. Existing biomarker profile reported from a local test obtained in a CAP/CLIA, ISO or equivalent laboratory per institutional guidelines
    7. Provision of archival tumor tissue sample (or if adequate archival tumor tissue is not available, provision ofa fresh biopsy if there is a lesion that can be safelybiopsied).Note: If adequate archived tumor tissue is not available and/or a fresh biopsy cannot be safely performed, the patient may still be eligible with prior sponsor approval.
    8. Ability to comply with the protocol and study procedures detailed in the Schedule of Assessments.
    9. Ability to swallow and retain oral medications.
    10. Acceptable organ function at Screening, as evidenced by the following laboratory data:
    a. Serum creatinine ≤1.5 × upper limit of normal (ULN) or calculated creatinine clearance ≥60 mL/min using the Cockcroft-Gault equation or by 24-hour urine collection
    b. Total bilirubin ≤1.5 × ULN or <3.0 × ULN if known Gilbert’s disease.
    c. Serum albumin ≥2.5 g/dL
    d. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN unless liver metastases are present and thought to be a reason for AST/ALT elevation, in which case they must be ≤5 × ULN
    11. Acceptable hematologic function at Screening
    a. No red blood cell or platelet transfusions or growth factors within 7 days of the first dose of RP-3500 for module 1 and within 14 days of first dose of study drug/s for modules 1 to 5.
    b. Module 1: Hemoglobin ≥9.5 g/dL
    Module 2 to 5: Hemoglobin ≥10 g/dL
    c. ANC ≥1700 cells/mm3
    d. Platelet count ≥140,000 cells/mm3
    12. Negative pregnancy test for women of childbearing potential (WOCBP) at Screening (serum test only) and prior to the first dose of study drug.
    13. Resolution of all toxicities of prior therapy or surgical procedures to baseline or Grade 1 (except for neuropathy, hypothyroidism requiring medication and alopecia which must have resolved to Grade ≤2). Any prior radiation (with exceptions for palliative radiotherapy) must have been completed at least 7 days prior to the start of study drugs, and patients must have recovered from any acute adverse effects prior to the start of study treatment.
    14. Male patients with female partners of childbearing potential must follow a contraception method (oral contraceptives allowed) at least as conservative as Clinical Trial Facilitation Group (CTFG) recommendations during their participation in the study and for 6 months following last dose of study drug. Male patients must also refrain from donating sperm during their participation in the study and for 6 months following last dose of study drug.
    15. Life expectancy ≥12 weeks after the start of the treatment according to the investigator's judgment.
    E.4Principal exclusion criteria
    Main criteria are the following ones (additional criteria can exist, depending on the module):
    1. Chemotherapy, small molecule anticancer or biologic anticancer therapy given within 14 days prior to first dose of study drug. For patients with breast or prostate cancer continuation of
    long-term luteinizing hormone-releasing hormone (LHRH) or gonadotrophin releasing hormone (GnRH) are allowed if these medications were prescribed for at least 4 months before trial entry.
    2. History or current condition (such as transfusion-dependent anemia or thrombocytopenia), therapy, or laboratory abnormality that might confound the study results, or interfere with the patient's participation for the full duration of the study treatment.
    3. Prior therapy with an ATR or DNA-dependent protein kinase inhibitor.
    4. Known hypersensitivity to any of the ingredients of RP-3500.
    5. Life-threatening illness, medical condition, active uncontrolled infection, or organ system dysfunction (such as coagulopathy, encephalopathy or ascites requiring drainage within 4 weeks prior to enrollment) or other reasons which, in the investigator's opinion, could compromise the patient's safety, or interfere with or compromise the integrity of the study outcomes.
    6. Uncontrolled, symptomatic brain metastases. Patients with previously treated brain metastases may participate provided the metastases are stable (without evidence of progression by imaging for at least 4 weeks prior to the first dose of study drug and any neurologic symptoms are controlled and stable), have no evidence of new or enlarging brain metastases, and are clinically stable off steroids for at least 7 days prior to study drug.
    7. Uncontrolled hypertension (systolic blood pressure [BP] ≥160 mmHg; diastolic BP ≥100 mmHg) despite adequate treatment prior to first dose of RP-3500.
    8. Patients with active, uncontrolled bacterial, fungal, or viral infection, including hepatitis B virus (HBV), hepatitis C virus (HCV), known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness. In equivocal cases, patients whose viral load is negative, may be eligible. HIV seropositive patients who are healthy and low risk for AIDS related outcomes could be considered eligible. Eligibility criteria for HIV positive patients should be evaluated and discussed with Sponsor’s Medical Monitor, and will be based on current and past cluster of differentiation 4 (CD4) and t-cell counts, history (if any) of AIDS-defining conditions (eg, opportunistic infections), and status of HIV treatment.
    9. Moderate or severe hepatic impairment (ie, Child-Pugh class B or C).
    10. History or presence of an abnormal ECG that is clinically significant in the investigator's opinion, including complete left bundle branch block, second- or third-degree heart block, or recent history of myocardial infarction that in the opinion of the Investigator will pose an increased risk of rhythm abnormalities.
    11. QT interval corrected using Fridericia's formula (QTcF) >470 msec demonstrated by at least 2 ECGs >30 minutes apart.
    12. History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias such as structural heart disease (eg, severe left ventricular systolic dysfunction, left ventricular hypertrophy),
    coronary heart disease (symptomatic or with ischemia demonstrated by diagnostic testing), clinically significant electrolyte abnormalities (eg, hypokalemia, hypomagnesemia, hypocalcemia), or family history of sudden unexplained death or long QT syndrome.
    13. Current treatment with medications that are well-known to prolong the QT interval.
    14. History of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) diagnosis.
    15. Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol and/or follow-up procedures outlined in the protocol.
    16. Patients who are receiving strong CYP3A inhibitors or inducers, P-glycoprotein (P-gP) inhibitors and/or breast cancer resistant protein (BCRP) inhibitors within 14 days prior to first dose of study drug
    17. Patients who are pregnant or breastfeeding.
    E.5 End points
    E.5.1Primary end point(s)
    Safety:
    • Dose-limiting toxicities (DLTs)
    • Incidence of Treatment-emergent adverse event (TEAEs), treatment related TEAE, TEAEs leading to death, SAE, treatment related serious adverse event (SAE), TEAE leading to study drug discontinuation, TEAE leading to dose modifications and TEAE leading to study discontinuation summarized by system organ class (SOC) and MedDRA preferred term (PT).
    • Changes in clinical laboratory parameters (hematology, chemistry, urinalysis), Common Terminology Criteria for Adverse Events (CTCAE) graded laboratory toxicities, vital signs, Eastern Cooperative Oncology Group (ECOG) performance status, ECG parameters, Physical examinations (PEs) and usage of concomitant medications
    • 4β-hydroxycholesterol, a biomarker of CYP3A induction, will be evaluated at a pharmacologically active dose level

    Efficacy:
    • Overall response rate: best response of CR or PR, based on Investigator’s assessment using RECIST v1.1 criteria, or response in CA-125 or PSA (for patients with prostate cancer without measurable disease) as per GCIG or PCWG3.
    • Objective response rate (ORR): confirmed best response of complete response (CR) or partial response (PR), based on investigator’s assessment using RECIST v1.1
    • Duration of objective response (DOR): based on investigator’s assessment using RECIST v1.1
    • Clinical benefit rate: CR + PR + stable disease [SD] ≥4 months, based on investigator’s assessment using RECIST v1.1, CA-125 response by GCIG criteria, or PSA response based on PCWG3 (for patients with prostate cancer without measurable disease).
    • Progression-free survival time (PFS) and rate of PFS at 6 months, based on investigator’s assessment using RECIST v1.1
    • Overall survival (OS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Safety:
    Throughout the Trial

    Efficacy:
    Confirmed overall response rate (ORR), duration of response (DOR), clinical benefit rate (CR + PR + stable disease [SD] ≥4 months), progression free survival (PFS) at 6 months, and overall survival (OS) at 12 months in the analysis population
    E.5.2Secondary end point(s)
    Pharmacokinetics:
    Blood samples will be drawn to determine RP-3500 and talazoparib PK parameters. Blood samples will be collected at the timepoints outlined in each module. Blood samples for the analysis of 4β-hydroxycholesterol, a biomarker of CYP3A induction, and total cholesterol will be collected in patients in Module 1c. The PK of gemcitabine will not be assessed in this study.

    Biomarkers:
    Pre- and on-treatment tumor biopsy samples will be collected to confirm target engagement at each dose/schedule and RP2D through measuring biomarkers such as pKAP1 and p-gammaH2Ax in pre- and on-treatment samples in Modules 1 and 3. Changes in the tumor-immune microenvironment also will be measured. Blood samples will be collected for ctDNA genomic analyses at timepoints outlined in Modules 1, 2, 3, and 4. Baseline genomic profiles will be correlated with response to RP-3500 (or RP-3500 in combination with talazoparib or gemcitabine).
    E.5.2.1Timepoint(s) of evaluation of this end point
    PK and biomarker analysis timepoints vary by module.
    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 Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Food effect and QTc evaluation
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial8
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA1
    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
    Canada
    United States
    United Kingdom
    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 years4
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months2
    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: 361
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 90
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 451
    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)
    Patients who discontinue from all study drugs will continue to receive follow-up assessments as part of the study unless they are discontinued from the study. A Survival Follow-up Period will commence after end of treatment and subjects will be assessed every 3 months [± 2 weeks] for 1 year. There is no specific plan for treatment or care after the subject has ended the participation in the trial. Patients are to discuss their treatment options with their doctor.
    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 Decision2020-09-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-08-20
    P. End of Trial
    P.End of Trial StatusOngoing
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