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    Summary
    EudraCT Number:2017-000800-59
    Sponsor's Protocol Code Number:LOXO-RET-17001
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-08-09
    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 ConcernedGermany - BfArM
    A.2EudraCT number2017-000800-59
    A.3Full title of the trial
    A Phase 1 /2 Study of Oral LOXO-292 in Patients with Advanced Solid Tumors, Including RET Fusion-Positive Solid Tumors, Medullary Thyroid Cancer, and Other Tumors with RET Activation (LIBRETTO-001)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 1/2 study on the effects of LOXO-292 (study drug) in patients with advanced solid tumors
    A.3.2Name or abbreviated title of the trial where available
    LIBRETTO-001
    A.4.1Sponsor's protocol code numberLOXO-RET-17001
    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 SponsorLoxo Oncology, Inc. a wholly owned subsidiary of Eli Lilly and Company
    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 supportLoxo Oncology, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedpace
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street AddressLe Dauphiné Part-Dieu
    B.5.3.2Town/ cityLyon
    B.5.3.3Post code69003
    B.5.3.4CountryFrance
    B.5.4Telephone number+33426 830 067
    B.5.5Fax number+33975188501
    B.5.6E-mailregsubmissions@medpace.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/18/2071
    D.3 Description of the IMP
    D.3.1Product nameSelpercatinib
    D.3.2Product code LOXO-292
    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 INNSelpercatinib
    D.3.9.2Current sponsor codeLOXO-292
    D.3.9.3Other descriptive nameLOXO-292
    D.3.9.4EV Substance CodeSUB186998
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/18/2071
    D.3 Description of the IMP
    D.3.1Product nameSelpercatinib
    D.3.2Product code LOXO-292
    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 INNSelpercatinib
    D.3.9.2Current sponsor codeLOXO-292
    D.3.9.3Other descriptive nameLOXO-292
    D.3.9.4EV Substance CodeSUB186998
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/18/2071
    D.3 Description of the IMP
    D.3.1Product nameSelpercatinib
    D.3.2Product code LOXO-292
    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 INNSelpercatinib
    D.3.9.2Current sponsor codeLOXO-292
    D.3.9.3Other descriptive nameLOXO-292
    D.3.9.4EV Substance CodeSUB186998
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/18/2071
    D.3 Description of the IMP
    D.3.1Product nameSelpercatinib
    D.3.2Product code LOXO-292: Powder for Oral Suspension
    D.3.4Pharmaceutical form Powder for oral suspension
    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 INNSelpercatinib
    D.3.9.2Current sponsor codeLOXO-292
    D.3.9.3Other descriptive nameLOXO-292
    D.3.9.4EV Substance CodeSUB186998
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5000
    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
    Male or female patients with a locally advanced or metastatic solid tumor with evidence of a RET gene alteration in tumor and/or blood.
    E.1.1.1Medical condition in easily understood language
    Male or female patients with locally advanced or metastatic solid tumor (phase 1) and with evidence of a RET gene alteration (phase 2).
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10027105
    E.1.2Term Medullary thyroid 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 21.1
    E.1.2Level PT
    E.1.2Classification code 10061873
    E.1.2Term Non-small cell lung cancer
    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
    Phase 1
    To determine the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) of LOXO-292

    Phase 2
    To assess, for each phase 2 expansion cohort, the anti-tumor activity of LOXO-292 by determining ORR using RECIST 1.1 or RANO, as appropriate to tumor type, as assessed by independent review committee (IRC).
    E.2.2Secondary objectives of the trial
    Phase 1
    • To determine the safety profile and tolerability of LOXO-292.
    • To characterize the pharmacokinetics (PK) properties of LOXO-292.
    • To assess the anti-tumor activity of LOXO-292 by determining overall response rate (ORR) using Response Evaluation in Solid Tumors Version 1.1 (RECIST 1.1) or Response Assessment in Neuro-Oncology (RANO), as appropriate to tumor type

    Phase 2
    •To assess, for each expansion cohort, the anti-tumor activity of LOXO-292
    •To determine the safety profile and tolerability of LOXO-292.
    •To characterize the PK properties of LOXO-292
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Phase 1
    1. Patients with a locally advanced or metastatic solid tumor who:
    -have progressed on or are intolerant to standard therapy, or
    -no standard therapy exists, or in the opinion of the Investigator, are not candidates for or would be unlikely to tolerate or derive significant clinical benefit from standard therapy, or
    -decline standard therapy.
    2. Prior multi-kinase inhibitors (MKIs) with anti-RET activity are allowed.
    3. A RET gene alteration is not required initially. Once adequate PK exposure is achieved, evidence of RET gene alteration in tumor and /or blood is required
    4. Measurable or non-measurable disease as determined by RECIST 1.1 or RANO as appropriate to tumor type.
    5. At least 18 years of age.
    -Enrollment of minors are not allowed in Germany.
    6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 (age ≥ 16 years) or Lansky Performance Score (LPS) ≥ 40% (age < 16 years) with no sudden deterioration 2 weeks prior to the first dose of study treatment.
    7. Life expectancy of at least 3 months.
    8. Archived tumor tissue sample available
    9. Adequate hematologic status, defined as:
    • Absolute neutrophil count (ANC) ≥ 1.0 × 109/L not requiring growth factor support for at least 7 days prior to treatment, and
    • Platelet count ≥ 75 × 109/L not requiring transfusion support for at least 7 days prior to treatment, and
    • Hb ≥ 9 g/dL not requiring transfusion support or erythropoietin for at least 7 days prior to treatment.
    10. Adequate hepatic function, defined as:
    • ALT and AST ≤ 2.5 × the upper limit of normal (ULN) or ≤ 5 × ULN with documented liver involvement (such as liver metastasis or a primary biliary tumor); and
    • Total bilirubin ≤ 1.5 × ULN or ≤ 3 × ULN with documented liver involvement (patients with Gilbert’s Disease may be enrolled with prior Sponsor approval).
    11. Adequate renal function, with estimated glomerular filtration rate ≥ 30 mL/minute.
    12. Ability to swallow capsules and comply with outpatient treatment, laboratory monitoring, and required clinic visits for the duration of study participation. If the liquid formulation is widely available the requirement may be waived with Sponsor approval.
    13. Willingness of men and women of reproductive potential to observe conventional and effective birth control for the duration of treatment and for 3 months following the last dose of study treatment;
    14. Only adult patients capable of understanding the nature, significance and consequences of the clinical trial and providing informed consent are eligible for participation in the planned clinical trial.

    Phase 2
    As for phase 1 with the following modifications:
    1. Cohorts 1 and 3: failed or intolerant to standard of care; Cohorts 2 and 4: without prior standard first-line therapy; see Table 3 for examples.
    2. Cohorts 1-4: enrollment will be restricted to patients with evidence of a RET gene alteration in tumor (i.e., not just blood) as defined in Table 3-3. However, a positive germline DNA test for a RET gene mutation as defined in Table 3-3 is acceptable in the absence of tumor tissue testing for patients with MTC.
    3. Cohorts 1-4: at least one measurable lesion as defined by RECIST 1.1 or RANO, as appropriate to tumor type and not previously irradiated (unless PD for the irradiated lesion[s] has been radiographically documented).
    4. Cohort 4: radiographic PD within the previous 14 months.
    5. Cohort 6: Patients who otherwise are eligible for Cohorts 1-5 who discontinued another RET inhibitor due to intolerance may be eligible with prior Sponsor approval.
    Note: Examples of RET inhibitors may include TPX0046, pralsetinib (BLU-667), or BOS172739.
    E.4Principal exclusion criteria
    1. Phase 2 Cohorts 1-4: an additional validated oncogenic driver that could cause resistance to LOXO-292 treatment. See Appendix C (Table 11-3) for examples.
    2. Phase 2 Cohorts 1-5: prior treatment with a selective RET inhibitor(s) (including investigational selective RET inhibitor[s]).
    Note:
    Patients otherwise eligible for Cohorts 1-5 who discontinue another selective RET inhibitor may be eligible for Phase 2 Cohort 6 with prior Sponsor approval.
    3. Investigational agent or anticancer therapy (including chemotherapy, biologic therapy, immunotherapy, anticancer Chinese medicine or other anticancer herbal remedy) within 5 half-lives or 2 weeks (whichever is shorter) prior to planned start of selpercatinib. In addition, no concurrent investigational anti-cancer therapy is permitted.
    4. Major surgery (excluding placement of vascular access) within 4 weeks prior to planned start of selpercatinib.
    5. Radiotherapy with a limited field of radiation for palliation within 1 week of the first dose of study treatment, with the exception of patients receiving radiation to more than 30% of the bone marrow or with a wide field of radiation, which must be completed at least 4 weeks prior to the first dose of study
    treatment.
    6. Any unresolved toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting study treatment with the exception of alopecia and Grade 2, prior platinum-therapy related neuropathy.
    7. Symptomatic primary central nervous system (CNS) tumor, metastases, leptomeningeal carcinomatosis, or untreated spinal cord compression.
    Exception:
    Patients are eligible if neurological symptoms and CNS imaging are stable and steroid dose is stable for 14 days prior to the first dose of LOXO-292 and no CNS surgery or radiation has been performed for 28 days, 14 days if stereotactic radiosurgery (SRS).
    8. Clinically significant active cardiovascular disease or history of myocardial infarction within 6 months prior to planned start of selpercatinib or prolongation of the QT interval corrected for heart rate using Fridericia's formula (QTcF) > 470 msec during Screening. Correction of suspected drug-induced QTcF prolongation may be attempted at the Investigator’s discretion if clinically safe to do so.
    9. Active uncontrolled systemic bacterial, viral, or fungal infection, or serious ongoing intercurrent illness, such as hypertension or diabetes, despite optimal treatment. Screening for chronic conditions is not required.
    10. Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal absorption of the study drug.
    11.Uncontrolled symptomatic hyperthyroidism or hypothyroidism.
    12.Uncontrolled symptomatic hypercalcemia or hypocalcemia.
    13. Pregnancy or lactation.
    14. Active second malignancy other than minor treatment of indolent cancers.
    15. History of hypersensitivity to any of the study drug capsule components, or any of the liquid suspension components (for patients that cannot swallow capsules).
    E.5 End points
    E.5.1Primary end point(s)
    Phase 1
    MTD/RP2D

    Phase 2
    ORR based on RECIST 1.1 or RANO, as appropriate to tumor type, assessed by IRC
    E.5.1.1Timepoint(s) of evaluation of this end point
    MTD/RP2D: at each end of dose escalation cohort

    ORR: Every 8 weeks (±7 days) starting with D1 C3 through D1 C13. Every 12 weeks (±7 days) thereafter. During long-term follow-up: approximately every 3 months (±1 moth) for up to two years after the last dose of study drug.
    E.5.2Secondary end point(s)
    Phase 1
    • Frequency, severity, and relatedness of TEAEs and SAEs, changes in hematology and blood chemistry values, assessments of physical examinations, vital signs, and ECGs.
    • Plasma concentrations of LOXO-292 and PK parameters, including but not limited to area under the concentration versus time curve from time 0 to 24 hours (AUC -24), maximum drug concentration (Cmax), time to maximum plasma concentration (Tmax) and degree of accumulation.
    • ORR based on RECIST 1.1 or RANO, as appropriate to tumor type

    Phase 2
    •Parameters of anti-tumor activity/clinical benefit, including: ORR (by Investigator), best change in tumor size from baseline (by IRC and Investigator), DOR (by IRC and Investigator), CNS ORR (by IRC), CNS DOR (by IRC), time to any and best response (by IRC and Investigator), CBR (by IRC and Investigator), PFS (by IRC and Investigator), and OS
    •Frequency, severity, and relatedness of TEAEs and SAEs, changes in hematology and blood chemistry values, and assessments of physical examinations, vital signs, and ECGs
    •Plasma concentrations of LOXO-292 and PK parameters, including but not limited to AUC0-24, Cmax and Tmax
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Frequency, severity, and relatedness of TEAEs and SAEs, changes in hematology and blood chemistry values, assessments of physical examinations, vital signs, and ECGs: throughout trial
    • Plasma concentration of LOXO-292 and PK parameters : Cycle1 D8
    • ORR, Parameters of anti-tumor activity/clinical benefit: Every 8 weeks (±7 days) starting with D1 C3 through D1 C13. Every 12 weeks (±7 days) thereafter. During long-term follow-up: approximately every 3 months (±1 month) for up to two years after the last dose of study drug.
    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 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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
    Australia
    Canada
    Denmark
    France
    Germany
    Hong Kong
    Israel
    Italy
    Japan
    Korea, Republic of
    Netherlands
    Poland
    Singapore
    Spain
    Switzerland
    Taiwan
    United Kingdom
    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 years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days28
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days28
    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: 589
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 294
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 225
    F.4.2.2In the whole clinical trial 1070
    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 Safety Follow-up (SFU) visit 28 days (+7 days) after the last dose of study drug will occur to check on the status of
    unresolved SAEs.
    All patients will enter Long-Term Follow-Up (LTFU) (approximately every 3 months, until the patient, has withdrawn consent for further participation, is lost to follow-up, has died, or the Sponsor makes a decision to close the study. Assessments may include: subsequent anticancer therapy(ies) and survival status. LTFU may be conducted by phone.
    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 Decision2019-04-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-06-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-06-12
    The status of studies in GB is no longer updated from 1.1.2021
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