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    Summary
    EudraCT Number:2017-004927-56
    Sponsor's Protocol Code Number:SRA737-03
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2018-05-14
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2017-004927-56
    A.3Full title of the trial
    A Phase 1b/2, Open-label, Multicenter Dose-ranging Trial to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of SRA737 in Combination With Niraparib in Subjects With Metastatic Castration-resistant Prostate Cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 1b/2 Trial of SRA737 in Combination with Niraparib in Subjects with Metastatic Castration-resistant Prostate Cancer (mCRPC)
    A.4.1Sponsor's protocol code numberSRA737-03
    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 SponsorSierra Oncology, Inc.
    B.1.3.4CountryUnited States
    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 supportSierra Oncology, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSierra Oncology, Inc.
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street Address46701 Commerce Center Drive
    B.5.3.2Town/ cityPlymouth, MI
    B.5.3.3Post code48170
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1604558-6575
    B.5.6E-mailmbond@sierraoncology.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 nameSRA737 capsules
    D.3.2Product code SRA737
    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 INNSRA737
    D.3.9.2Current sponsor codeSRA737
    D.3.9.3Other descriptive nameSRA737 citrate
    D.3.9.4EV Substance CodeSUB180852
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 nameSRA737 capsules
    D.3.2Product code SRA737
    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 INNSRA737
    D.3.9.2Current sponsor codeSRA737
    D.3.9.3Other descriptive nameSRA737 citrate
    D.3.9.4EV Substance CodeSUB180852
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 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 nameSRA737 capsules
    D.3.2Product code SRA737
    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 INNSRA737
    D.3.9.2Current sponsor codeSRA737
    D.3.9.3Other descriptive nameSRA737 citrate
    D.3.9.4EV Substance CodeSUB180852
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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: 4
    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 nameSRA737 capsules
    D.3.2Product code SRA737
    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 INNSRA737
    D.3.9.2Current sponsor codeSRA737
    D.3.9.3Other descriptive nameSRA737 citrate
    D.3.9.4EV Substance CodeSUB180852
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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: 5
    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 nameNiraparib
    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 INNNIRAPARIB
    D.3.9.1CAS number 1038915-60-4
    D.3.9.3Other descriptive nameniraparib tosylate monohydrate
    D.3.9.4EV Substance CodeSUB177208
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    Histologically or cytologically confirmed adenocarcinoma of the prostate
    E.1.1.1Medical condition in easily understood language
    Patients with metastatic castration-resistant prostate 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 LLT
    E.1.2Classification code 10076506
    E.1.2Term Castration-resistant prostate cancer
    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
    1) To determine the maximum tolerated dose (MTD) and schedule of SRA737 in combination with niraparib in subjects with mCRPC and to determine a recommended Phase 2 dose (RP2D) and schedule of SRA737 in combination with niraparib

    2) To assess the preliminary efficacy of SRA737 in combination with niraparib based on overall response rate
    E.2.2Secondary objectives of the trial
    1) To characterize the pharmacokinetic (PK) profiles of SRA737 and niraparib when administered in combination

    2) To assess the relationship between response and the presence of selected genomic alterations as detected in tumor tissue and/or circulating tumor deoxyribonucleic acid (ctDNA)

    3) To assess additional measures of efficacy of the combination of SRA737 and niraparib
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Dose escalation and expansion cohorts:

    1) Written informed consent prior to any trial specific procedures, sampling and analyses.

    2) Attained the age of 18 years at the time consent is given.

    3) Histologically or cytologically confirmed adenocarcinoma of the prostate.

    4) Surgically or medically castrated, with serum testosterone levels of ≤ 50 ng/dL (1.73 nM). For subjects currently being treated with luteinizing hormone-releasing hormone (LHRH) agonists and antagonists, therapy must be continued throughout the trial.

    5) Prior treatment with at least 1 prior taxane containing regimen.

    6) Prior treatment with at least 1 of the following: abiraterone acetate, enzalutamide, or investigational androgen receptor (AR)-targeted agent. A wash-out period of 4 weeks is required for subjects who received first and second generation anti-androgen therapy including enzalutamide and apalutamide.

    7) Disease progression on or after most recent prior therapy for mCRPC; with disease progression in this context being based on any one of the following:
    a. PSA progression as defined in Section 6.2.2 with a minimum of 2 consecutive rising levels taken 1 or more weeks apart (per PCWG3 criteria). Minimum starting value should be ≥ 2 ng/mL. If confirmed rise is the only indication of progression, then the minimum starting value should be 1 ng/mL.
    b. Radiographic progression of soft tissue by RECIST 1.1 or bone disease by PCWG3 criteria as defined in Appendix G in subjects with:
    I. Soft tissue disease, measurable by RECIST 1.1 defined as having 1 or more of the following:
    i. Nodal disease (pelvic or extrapelvic [retroperitoneal, mediastinal, thoracic, other]) with lesions ≥ 1.5 cm in the short axis.
    ii. Visceral disease (lung, liver, adrenal) with lesions ≥ 1 cm in the long axis.
    II. Bone disease (non-measurable) defined as having 2 or more new bone lesions in the absence of measurable soft tissue disease.

    8) Life expectancy of at least 12 weeks.

    9) Hematological and biochemical indices within the ranges shown below, measured within 1 week prior to the subject receiving their first dose of IMP (as listed in protocol table in the inclusion criteria).

    10) World Health Organization (WHO) performance status 0-1 with no deterioration over the 2 weeks prior to trial entry.

    11) Evaluable disease as demonstrated by any one of the following: A) Measurable disease per RECIST v1.1; B) Increasing PSA; or C) CTC count of ≥ 5 cells/7.5 mL of blood.

    Dose expansion cohort only:

    12) At least 20 of the planned 31 subjects must have radiographically measurable disease per RECIST v1.1. The remaining subjects may be eligible by increasing PSA or CTC count of ≥ 5 cells/7.5 mL of blood.
    E.4Principal exclusion criteria
    1) Any prior treatment with a Chk1 inhibitor, or prior treatment with an ATR inhibitor within 6 months prior to receiving the first dose of IMP.

    2) Have received the following prior or current anticancer therapy:
    a. Radiotherapy within 15 days prior to the first dose of IMP (except for symptom control and where the lesions will not be used as measurable disease)
    b. Endocrine therapy within 3 weeks prior to the first dose of IMP (except for LHRH agonists and antagonists for prostate cancer)
    c. Chemotherapy within 3 weeks prior to the first dose of IMP
    d. Immunotherapy within 6 weeks prior to the first dose of IMP
    e. Nitrosoureas or Mitomycin C within 6 weeks prior to the first dose of IMP
    f. Other IMPs within 4 weeks prior to the first dose of IMP

    3) Untreated brain or meningeal metastases that have not been stable (ie, asymptomatic and not progressing) for at least 8 weeks.

    4) Symptomatic or impending spinal cord compression unless appropriately treated and clinically stable.

    5) Initiated bisphosphonate or denosumab therapy or adjusted bisphosphonate or denosumab dose/regimen within 4 weeks prior to the first dose of IMP. Subjects on stable bisphosphonate or denosumab regimen are eligible and may continue treatment.

    6) Other malignancy within the past 2 years with the exception of adequately treated tumors that are associated with an expected 5-year disease-free survival of approximately 95% or better.

    7) Received a platelet transfusion or hematopoietic growth factors within 30 days prior to trial entry.

    8) Known history or current diagnosis of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML).

    9) Ongoing toxic manifestations of previous treatments greater than NCI-CTCAE Grade 1. Exceptions to this are alopecia or certain toxicities, which in the opinion of the investigator and the sponsor or sponsor’s designee monitor should not exclude the subject.

    10) Subjects with partners of childbearing potential unless they agree to take measures not to father children by using a highly effective method of contraception. Subjects with pregnant or lactating partners must be advised to use a barrier method of contraception to prevent exposure of the fetus or neonate. Refer to for details.

    11) Major surgery from which the subject has not yet recovered.

    12) At high medical risk because of nonmalignant systemic disease including active uncontrolled infection.

    13) Known to be serologically positive for hepatitis B, hepatitis C or human immunodeficiency virus (HIV).

    14) Serious cardiac condition, such as concurrent congestive heart failure, prior history of class III/ IV cardiac disease (New York Heart Association [NYHA] refer to Appendix B), left ventricular ejection fraction < 45% at baseline, history of cardiac ischemia within the past 6 months, or prior history of significant cardiac arrhythmia requiring treatment unless approved by the sponsor.

    15) Prior bone marrow transplant or extensive radiotherapy to greater than 25% of bone marrow within 8 weeks.

    16) Peanut allergy unless this restriction is removed by the sponsor (refer to Section 5.1 for details).

    17) QTcF > 450 msec.

    18) Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of IMP (eg, ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, or malabsorption syndrome).

    19) Not able to swallow capsules without chewing or crushing. Pre-existing duodenal stent and/or any GI disorder or defect that would, in the opinion of the investigator, interfere with the absorption of IMP.

    20)Known allergies, hypersensitivity, or intolerance to niraparib or its excipients, or SRA737’s excipients (refer to Investigator's Brochure).

    21. Rare hereditary problems of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.

    22. Is a participant or plans to participate in another interventional clinical trial, whilst taking part in this trial. Participation in an observational trial or interventional clinical trial which does not involve administration of an IMP and which would not place an unacceptable burden on the subject in the opinion of the investigator and sponsor or sponsor’s designee would be acceptable.

    23. Any other condition which in the investigator’s or sponsor’s opinion would not make the subject a good candidate for the clinical trial.

    Dose expansion cohort only
    24. Known to be positive for mutation of genes hypothesized to confer sensitivity to PARP inhibition (ie, BRCA1, BRCA2, ATM, CHEK2, FANCA, PALB2, BRIP1, and HDAC2) by central laboratory testing.
    E.5 End points
    E.5.1Primary end point(s)
    1) The frequency and severity of treatment emergent SAEs, discontinuations due to AEs, and laboratory abnormalities

    2) Response rate: defined as 1 of the following by Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria:
    A. Objective response rate of soft tissue (visceral or nodal disease) as defined by modified RECIST 1.1 with no evidence of bone progression
    B. PSA decline of ≥50% confirmed by a repeat reading at least 4 weeks later
    C. Conversion of CTC count from ≥ 5 cells/7.5 mL blood at baseline to < 5 cells/7.5 mL blood nadir confirmed by at least 2 readings 4 weeks apart
    E.5.1.1Timepoint(s) of evaluation of this end point
    1) SAE collection and monitoring will commence at the time the subject gives their written consent to participate in the trial, while AE collection and monitoring will commence at the time the subject receives their first dose of an IMP. The collection and monitoring of SAEs and AEs will continue until 30 days after the last administration of IMP(s). Monthly follow up is required for all SAEs and for those AEs considered drug related.

    2) At the end of the trial.
    E.5.2Secondary end point(s)
    1) Plasma concentration-time profile and PK parameters including, but not limited to: AUC0-inf (for SRA737 only), AUC0-tau (for SRA737 only), AUC0-24, Cmin (for SRA737 only), Cmax, Ctrough, Tmax, and t½

    2) Association of clinical response and presence of genomic markers at baseline

    3a) PSA response ≥ 50% based on PCWG3 criteria
    3b) PSA response ≥ 90% based on PCWG3 criteria
    3c) CTC response defined as CTC count = 0 in 7.5 mL of blood at 8 weeks post baseline
    3d) CTC0 response, defined as nadir decline to CTC count = 0 in 7.5 mL blood, confirmed by at least 2 readings 4 weeks apart
    3e) Duration of radiologic response based on PCWG3-modified RECIST 1.1
    3f) Duration of PSA response
    3g) Duration of CTC responses and conversion
    3h) Disease control rate based on PCWG3-modified RECIST 1.1
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) 48-hours intensive PK sampling after the initial dose of SRA737 during Day -7 to Day -2; 24-hours intensive PK sampling on Day 1 of Cycles 1 and 2. Predose sampling on Day 1 of C3, 4, 5, and 8. A PK sample collection as soon as feasible after the onset of a DLT.

    2) At the end of the trial.

    3) At the end of 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 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 No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Phase I/II study
    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 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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    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
    The ‘end of trial’ is defined as the date when the last subject has completed the Safety Follow-up visit or the long-term follow-up visit (whichever is later).
    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 months
    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: 35
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 35
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state70
    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)
    Standard of care
    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 Decision2018-07-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-08-10
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2019-02-11
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