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    Summary
    EudraCT Number:2017-000800-59
    Sponsor's Protocol Code Number:LOXO-RET-17001
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2018-09-03
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2017-000800-59
    A.3Full title of the trial
    A Phase 1 Study of Oral LOXO-292 in Patients with Advanced Solid Tumors, Including RET-Fusion Non Small Cell Lung Cancer, Medullary Thyroid Cancer, and Other Tumors with Increased RET Activity
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 1 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
    none
    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.
    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+33972 369 787
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameLOXO-292
    D.3.2Product code LOXO-292 : drug in capsule
    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 INNLOXO-292
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameLOXO-292
    D.3.2Product code LOXO-292 : 30% simple blend
    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 INNLOXO-292
    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: 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 nameLOXO-292
    D.3.2Product code LOXO-292 : 30% simple blend
    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 INNLOXO-292
    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.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
    Dose escalation: Male or female patients age 12 years or older with a locally advanced or metastatic solid tumor refractory to standard of care therapy, or for whom no standard of care therapy is available.
    Dose expansion: Male or female patients age 12 years or older 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 age 12 years or older with refractory advanced or metastatic solid tumor (dose escalation) or with evidence of a RET gene alteration (dose expansion).
    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 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 20.0
    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 20.0
    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
    Primary Objective (Phase 1):
    • To determine the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) of LOXO-292.

    Primary Objective (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 for 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 pharmacokinetic (PK) properties of LOXO-292.
    • To assess the anti-tumor activity of LOXO-292 by determining objective 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 by determining:
    o ORR based on RECIST 1.1 or RANO, as appropriate to tumor type, as assessed by Investigator;
    o Best change in tumor size from baseline as assessed by IRC and Investigator;
    o Duration of response (DOR) as assessed by IRC and Investigator;
    o Central nervous system (CNS) ORR based on RECIST 1.1 or RANO, as appropriate to tumor type, as assessed by IRC (for patients with brain metastases);

    For full list see protocol.

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion Criteria for 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 MKI(s) with anti-RET activity are allowed. Refer to Appendix A for examples of MKIs with anti-RET activity. However, prior treatment with a selective RET inhibitor(s) (including investigational selective RET inhibitor[s]) is prohibited. The specific agent(s), duration of treatment, clinical benefit and reason for discontinuation (e.g., progressive disease [PD], drug toxicity or intolerance) should be documented for all kinase inhibitors the patient has been exposed to.
    3. A RET gene alteration is not required initially. Once adequate PK is achieved (see Phase 1 and Maximum Tolerated Dose Determination), evidence of a RET gene alteration in tumor and/or blood is required (e.g., gene rearrangement and/or mutation, excluding synonymous, frameshift, or nonsense mutations) as identified through molecular assays, as performed for clinical evaluation. The RET alteration result should be generated from a laboratory with CLIA, ISO/EIC, CAP, or other similar certification. The Sponsor should be contacted to discuss test results from labs where such certification is not clearly demonstrated to determine eligibility. A positive germline test for a RET mutation is acceptable for patients with MTC. In all cases, an anonymized/redacted Molecular Pathology Report or other report(s) describing tumor RET (and other) alteration analysis should be submitted to the Sponsor or designee during/prior to eligibility.
    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
    • For countries and sites where approved, patients as young as 12 years of age may be enrolled.
    6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 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.
    • Patients who do not have adequate archival tumor tissue available should undergo a fresh tumor biopsy, if it is considered safe to perform prior to treatment (requirement may be waived with Sponsor approval).
    • If archived tumor tissue was obtained prior to progression on the last MKI with anti-RET activity, the patient should undergo a fresh tumor biopsy, if it is considered safe to perform, prior to treatment (optional).
    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
    • Hemoglobin (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 or 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 (up to 6 patients with an estimated glomerular filtration rate (eGFR) ≥ 15 and < 30 mL/minute will be allowed to enroll with Sponsor approval).
    12. Ability to swallow capsules and comply with outpatient treatment, laboratory monitoring, and required clinic visits for the duration of study participation.
    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; this may include barrier methods such as condom or diaphragm with spermicidal gel.

    Inclusion Criteria for Phase 2:
    As for phase 1 with the following modifications:
    1. Required prior first line therapies for Cohorts 1 and 3 are listed in table 3 of the protocol.
    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 2. However, a positive germline DNA test for a RET gene mutation as defined in Table 2 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 for 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.

    E.4Principal exclusion criteria
    Exclusion Criteria for Phase 1 and Phase 2:
    1. Phase 2, Cohorts 1-4, an additional validated oncogenic driver that could cause resistance to LOXO-292 treatment. See Appendix C for examples.
    2. Prior treatment with a selective RET inhibitor(s) (including investigational selective RET inhibitor[s]).
    3. Investigational agent or anticancer therapy within 5 half-lives or 2 weeks (whichever is shorter) prior to planned start of LOXO 292. In addition, no concurrent investigational anti-cancer therapy is permitted. Refer to the Protocol for allowable concurrent therapies. LOXO-292 may be started within less than 5 half lives or 2 weeks of prior therapy if considered by the Investigator to be safe and within the best interest of the patient, with prior Sponsor approval.
    4. Major surgery (excluding placement of vascular access) within 4 weeks prior to planned start of LOXO-292.
    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 CNS tumor, metastases, leptomeningeal carcinomatosis, or untreated spinal cord compression. Patients are eligible if neurologically stable and without increase in steroid dose 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 LOXO 292 or prolongation of the QT interval corrected for heart rate using Fridericia’s formula (QTcF) > 470 msec on at least 2/3 consecutive electrocardiograms (ECGs) and mean QTcF > 470 msec on all 3 ECGs 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 clinically significant, active disease process which in the opinion of the Investigator makes it undesirable for the patient to participate in the trial. 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. Current treatment with certain strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers. For prohibited medications (Appendix D).
    14. Current treatment with proton pump inhibitors (PPIs) (Appendix E).
    Note:
    Treatment with PPIs must be stopped 1 or more weeks prior to the first dose of LOXO-292. For recommended alternatives, refer to the Protocol.
    15. Pregnancy or lactation.
    16. Active second malignancy other than minor treatment of indolent cancers.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Endpoint (Phase 1):
    • MTD/RP2D.

    Primary Endpoint (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
    First 28-day cycle of LOXO-292 treatment.
    E.5.2Secondary end point(s)
    Secondary Endpoints (Phase 1):
    • Frequency, severity, and relatedness of TEAEs and serious adverse events (SAEs), changes in hematology and blood chemistry values, assessments of physical examinations, vital signs, and electrocardiograms (ECGs).
    • Plasma concentration of LOXO-292 and PK parameters, including but not limited toarea under the curve from time 0 to 24 hours (AUC0-24), maximum drug concentration (Cmax), time to maximum plasma concentration (Tmax), and degree of accumulation.
    • ORR based on RECIST 1.1or RANO, as appropriate to tumor type.

    Secondary Endpoints (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, 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.

    Exploratory Endpoints:
    • Differences in efficacy and safety based on LOXO-292 PK parameters.
    • Changes in CEA and calcitonin (patients with MTC) thyroglobulin (non-MTC patients), ACTH and cortisol (patients with Cushing’s disease related to their cancer) with LOXO-292 treatment.
    • Identity of RET gene fusions, mutations, and concurrently activated oncogenic pathways in tumor biopsies and cfDNA.
    • Changes from baseline in disease-related symptoms and HRQoL, as measured by EORTC QLQ-C30 (adults), PedsQL for teens (ages 13-17 years), PedsQL for children (age 12 years), and patient bowel diaries (MTC patients only).

    E.5.2.1Timepoint(s) of evaluation of this end point
    • Adverse drug reactions and serious adverse drug reactions, 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 D1&D8, Cycle3 D1, Cycle5 D5
    • ORR (CR+PR), DOR, proportion of patients that have any tumor regression as a best response, CBR, PFS, OS: Cycle2 and higher
    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) 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 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 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 EEA6
    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
    Denmark
    France
    Germany
    Hong Kong
    Italy
    Korea, Republic of
    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 years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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: 16
    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: 16
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 120
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 59
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 34
    F.4.2.2In the whole clinical trial 570
    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 AEs.
    All patients will enter Long-Term Follow-Up (LTFU) (~every 3 months for up to two years), for the purpose of confirming the resolution of any AEs, PD if not occurring on study, subsequent anticancer therapy(ies), and survival. 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 Decision2018-09-03
    N.Ethics Committee Opinion of the trial applicationWithdrawn
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-06-21
    P. End of Trial
    P.End of Trial Status
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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