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    The EU Clinical Trials Register currently displays   43801   clinical trials with a EudraCT protocol, of which   7258   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2021-001637-39
    Sponsor's Protocol Code Number:RP630601
    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:2021-05-05
    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 number2021-001637-39
    A.3Full title of the trial
    Phase 1 Study of the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Clinical Activity of RP-6306 Alone or in Combination with RP-3500 in Patients with Advanced Solid Tumors
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase 1 trial to study how safe and tolerable RP-6306 is, alone or in Combination with RP-3500, when administered in patients with certain types of cancer
    A.3.2Name or abbreviated title of the trial where available
    MYTHIC study
    A.4.1Sponsor's protocol code numberRP630601
    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, Suite 1650
    B.5.3.2Town/ cityCambridge, MA
    B.5.3.3Post code02142
    B.5.3.4CountryUnited States
    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-6306
    D.3.2Product code RP-6306
    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 INNNot assigned yet
    D.3.9.1CAS number Not assigned
    D.3.9.2Current sponsor codeRP-6306
    D.3.9.3Other descriptive nameD199
    D.3.9.4EV Substance CodeSUB235427
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number2.5 to 60
    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 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.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 solid tumors with CCNE1 amplification or deleterious mutations in FBXW7 or other proprietary gene
    E.1.1.1Medical condition in easily understood language
    To treat various cancer types that have specific mutations 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 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
    Module 1:
    • Assess the safety and tolerability of RP-6306 in patients with eligible advanced solid tumors
    • Define the maximum tolerated dose (MTD) of RP- 6306 monotherapy, and determine a recommended Phase 2 dose (RP2D) and preferred schedule

    Module 2:
    • Assess the safety and tolerability of RP-6306 in combination with RP-3500 in patients with molecularly selected, advanced solid tumors
    • Define the maximum tolerated dose (MTD) of RP-6306 in combination with RP-3500, and determine a recommended Phase 2 dose (RP2D) and preferred schedule
    E.2.2Secondary objectives of the trial
    Module 1:
    • Assess pharmacokinetic (PK) parameters of RP- 6306 monotherapy in fasted and fed states
    • Assess the relationship between pharmacodynamic biomarkers and PK of RP-6306 at different dose levels and/or schedules
    • Assess preliminary anti-tumor activity achieved with RP-6306 monotherapy in patients with each of the molecular subsets of advanced solid tumors: harboring either CCNE1 amplification or deleterious mutations in F-box and WD repeat domain containing 7 (FBXW7) or other proprietary gene

    Module 2:
    • Assess pharmacokinetic (PK) parameters of RP-6306 and RP-3500 when dosed in combination
    • Assess preliminary anti-tumor activity achieved with RP-6306 in combination with RP-3500 in patients with advanced solid tumors harboring CCNE1 amplification, FBXW7 or proprietary gene deleterious mutations, or other genomic alterations with mechanistic rationale as agreed upon by the Sponsor and Investigator
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent and assent, according to local guidelines, signed and dated by the participating patient or legal guardian prior to the performance of any study-specific procedures, sampling, or analyses.
    2. Male or female and ≥12 years-of-age at the time of signature of the informed consent form (ICF).
    3. Lansky performance status ≥50 for patients ≤16 years of age, or ECOG score of 0, 1, or 2 (Module 2 ECOG 0 or 1) for patients >16 years of age.
    4. All patients must have locally advanced or metastatic resistant or refractory solid tumors. Patients <18 years-of-age will be eligible only if standard or available curative therapy does not exist. Patients ≥18 years-of-age are eligible if, in the opinion of the investigator, the patient is not a candidate for, or would be unlikely to tolerate or derive significant clinical benefit from, appropriate standard-of-care therapy, or if the patient declines standard-of-care therapy.
    5. Patients <18 years of age must weigh at least 40 kg.
    6. Archived tumor tissue sample available or lesion that can be safely biopsied if the archival sample is not available.
    7. All patient’s tumors, except for types of endometrial cancer listed in criteria #8, must have evidence of at least one of the following as reported by a local CLIA-certified or equivalent (ex-United States [US]) laboratory and centrally confirmed by PODS:
    a. CCNE1 amplification (non-equivocal) as determined by either a tumor or plasma NGS test, or FISH
    b. FBXW7 deleterious mutations identified by either a tumor or plasma NGS test
    c. Proprietary gene deleterious mutations identified by either a tumor or plasma NGS test
    d. For backfill cohorts, tumors with other genes with mechanistic rationale agreed upon between the Sponsor and Investigator will be accepted.
    8. The following types of endometrial cancer are eligible (for Module 1 only):
    a. Serous endometrial cancer (p53 IHC must be confirmed to be aberrant or local NGS report confirming TP53 loss of function mutation must be provided)
    b. Carcinosarcoma of the endometrium
    c. Grade 3 endometrioid and undifferentiated carcinoma (p53 IHC must be confirmed to be aberrant or local NGS report confirming TP53 loss of function mutation must be provided; MMR IHC must be retained and/or tumor must be MSS; polymerase epsilon (POLE) hypermutated type must be excluded)
    9. Measurable disease as per RECIST v1.1.
    10. Ability to comply with the protocol and study procedures detailed in the Schedule of Assessments.
    11. Ability to swallow and retain oral medications.
    12. Acceptable organ function at Screening, as evidenced by the following laboratory data:
    a. Serum creatinine ≤1.5 × 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) ≤3.0 × ULN
    13. Acceptable hematologic function at Screening:
    a. No red blood cell (RBC) or platelet transfusions or growth factors within 7 days of the first dose of RP-6306
    b. Hemoglobin ≥9.0 g/dL (or ≥10.0 g/dL for Module 2 only)
    c. ANC ≥1500 cells/mm3
    d. Platelet count ≥100,000 cells/mm3
    14. Negative pregnancy test (serum) for women of childbearing potential at Screening.
    15. Male patients with female partners of childbearing potential must follow a contraception method (oral contraceptives allowed) during their participation in the study for 6 months following last dose of 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.
    16. 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).
    17. Any prior radiation 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.
    18. Life expectancy ≥12 weeks after the start of the treatment according to the investigator’s judgment.
    Additional Inclusion Criteria for Module 1c:
    19. Ability to consume a high-fat meal and fast for 12 hours. Module 1c will only be open to patients ≥18 years-of-age.
    E.4Principal exclusion criteria
    1. Chemotherapy or small molecule antineoplastic agent given within 21 days or <5 half-lives, whichever is shorter, prior to first dose of study drug. For drugs for which 5 half-lives is ≤21 days, a minimum of 10 days between termination of the prior treatment and administration of RP-6306 treatment is required. For patients with breast or prostate cancer, continuation of long-term luteinizing hormone-releasing hormone (LHRH), gonadotrophin releasing hormone (GnRH), or previously prescribed Receptor Activator of Nuclear Factor kB Ligand (RANKL) inhibitor are allowed if these medications were prescribed for at least 3 months before trial entry. Bisphosphonates are allowed if prescribed at least 28 days prior to enrollment.
    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. Patients who are pregnant or breastfeeding.
    4. Known sensitivity to any of the ingredients of RP-6306 (and RP-3500 for Module 2).
    5. Patient who are unable to swallow oral medications.
    6. Life-threatening illness, medical condition, active uncontrolled infection, or organ system dysfunction (such as ascites requiring drainage within 4 weeks prior to enrollment, coagulopathy, or encephalopathy), or other reasons which, in the investigator’s opinion, could compromise the participating patient’s safety, or interfere with or
    compromise the integrity of the study outcomes.
    7. Major surgery (excluding placement of vascular access) within 4 weeks prior to first dose of RP-6306.
    8. 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 enlarged brain metastases, and are clinically stable and off steroids for at least 7 days prior to study drug.
    9. Uncontrolled hypertension (systolic blood pressure [BP] ≥160 mmHg; diastolic BP ≥100 mmHg) despite adequate treatment prior to first dose of RP-6306 (and RP-3500 for Module 2).
    10. 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 AIDSrelated outcomes could be considered eligible. Eligibility criteria for HIV positive patients should be evaluated and discussed with the sponsor’s medical monitor and will be based on current and past CD4 and T-cell counts, history (if any) of AIDS defining conditions (e.g., opportunistic infections), and status of HIV treatment
    11. Moderate or severe hepatic impairment (i.e., Child-Pugh class B or C).
    12. Any of the following cardiac diseases currently or within the last 6 months as defined by New York Heart Association (NYHA) ≥Class 2:
    a. Unstable angina pectoris
    b. Congestive heart failure
    c. Acute myocardial infarction
    d. Conduction abnormality not controlled with pacemaker or medication
    e. Significant ventricular or supraventricular arrhythmias (patients with chronic rate-controlled atrial fibrillation in the absence of other cardiac abnormalities are eligible)
    f. Clinically significant electrolyte abnormalities (e.g., hypokalemia, hypomagnesemia, hypocalcemia), or family history of sudden unexplained death or long ECG interval measured from the onset of the QRS complex to the end of the T wave (QT) syndrome
    13. Mean resting QT interval corrected for heart rate (QTc) interval using the Fridericia formula (QTcF) >450 msec/male and >470 msec/female (as calculated per institutional standards) obtained from 3 ECGs >1 minute apart at study entry.
    14. Current treatment with medications that are well-known to prolong the QT interval.
    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 (and P-gp inhibitors and/or BCRP inhibitors for Module 2 only) within 14 days prior to first dose of study drug.

    Additional exclusion criteria for Module 2:
    17. Prior therapy with an ATR, DNA-PK, PKMYT1, or WEE1 inhibitor.
    E.5 End points
    E.5.1Primary end point(s)
    • Treatment-emergent adverse events (TEAEs), physical examinations (PEs), safety laboratory assessments, electrocardiograms (ECGs), and vital sign measurements
    • Dose-limiting toxicities (DLTs)

    E.5.1.1Timepoint(s) of evaluation of this end point
    Throughout the trial


    E.5.2Secondary end point(s)
    Module 1:
    • Plasma concentrations of RP-6306) with calculation of maximum observed plasma concentration (Cmax), time to maximum observed plasma concentration (Tmax), minimum observed plasma concentration (Cmin), area under the plasma concentration-time curve (AUC), elimination t1/2, and other parameters as appropriate.
    • Assessment of biomarkers (e.g., g-H2AX, p-CDK1 Thr14) in pre- and on-treatment biopsies, and circulating tumor DNA (ctDNA) dynamics during treatment.
    • Best percent change in tumor size from baseline, objective response rate (ORR), tumor marker response, duration of response (DOR), clinical benefit rate (CBR), available progression-free survival (PFS), and overall survival (OS) data

    Module 2:
    • Plasma concentrations of RP-6306 and RP-3500 with calculation of maximum observed plasma concentration (Cmax), time to maximum observed plasma concentration (Tmax), minimum observed plasma concentration (Cmin), area under the plasma concentration-time curve (AUC), elimination t1/2, and other parameters as appropriate.
    • Best percent change in tumor size from baseline, ORR, DOR, CBR, tumor marker response; PFS, and OS data
    E.5.2.1Timepoint(s) of evaluation of this end point
    Throughout the trial
    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 No
    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
    Tolerability (for all modules) and food effect (for Module 1)
    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) No
    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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 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
    Denmark
    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 years3
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days30
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days30
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 10
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 10
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 85
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 85
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Adolescents patients 12-17 years of age
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 180
    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)
    After treatment discontinuation patients will be followed for survival. Survival Follow-Up assessments will be done every 3 months (± 2 weeks) until the end of study unless the patient withdraws consent to the study. 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 Decision2021-05-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-06-02
    P. End of Trial
    P.End of Trial StatusOngoing
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