Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43614   clinical trials with a EudraCT protocol, of which   7207   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools

    < Back to search results

    Print Download

    EudraCT Number:2017-004246-20
    Sponsor's Protocol Code Number:20810
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-04-08
    Trial results
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2017-004246-20
    A.3Full title of the trial
    Bayer 20810 - A Phase 1/2 Study of the TRK Inhibitor Selitrectinib (BAY 2731954) in Adult and Pediatric Subjects with Previously Treated NTRK Fusion Cancers

    Formerly: LOXO-EXT-17005 - A Phase 1/2 Study of the TRK Inhibitor LOXO-195 in Adult and Pediatric Subjects with Previously Treated NTRK Fusion Cancers

    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Bayer 20810 - A Phase 1/2 Study of the TRK Inhibitor Selitrectinib (BAY2731954) in Adult and Pediatric Subjects with Previously Treated NTRK Fusion Cancers
    A.4.1Sponsor's protocol code number20810
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03215511
    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 SponsorBayer Consumer Care AG
    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 supportBayer Consumer Care AG
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBayer AG
    B.5.2Functional name of contact pointBayer Clinical Trials Contact
    B.5.3 Address:
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code13342
    B.5.4Telephone number+4930300139003
    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 nameSelitrectinib
    D.3.2Product code BAY 2731954
    D.3.4Pharmaceutical form Powder for oral suspension
    D.3.4.1Specific paediatric formulation Yes
    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 available
    D.3.9.1CAS number 2097002-61-2
    D.3.9.2Current sponsor codeBAY 2731954
    D.3.9.3Other descriptive nameSelitrectinib
    D.3.9.4EV Substance CodeSUB189790
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    NTRK fusion cancers previously treated with a TRK inhibitor
    E.1.1.1Medical condition in easily understood language
    Solid tumors of all type, including primary CNS tumors
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10049516
    E.1.2Term Malignant 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 21.0
    E.1.2Level PT
    E.1.2Classification code 10007958
    E.1.2Term Central nervous system neoplasm
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Phase 1:
    To determine the recommended dose for further study of oral selitrectinib in 2 patient groups defined as age 12 years and older and age < 12 years with previously treated neurotrophic tyrosine kinase (NTRK) fusion cancers.

    Phase 2:
    • To assess ORR by RECIST v1.1, as determined by an independent radiology review (IRR), in documented NTRK fusion cancer patients previously treated with a TRK inhibitor who have progressed.
    E.2.2Secondary objectives of the trial
    Phase 1
    • To characterize the pharmacokinetic (PK) properties of selitrectinib
    • To characterize the safety and tolerability of selitrectinib.
    • To assess objective response rate (ORR) according to best response by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as determined by Investigator.
    • To assess ORR according to best response by Response Assessment in Neuro Oncology (RANO), as determined by Investigator, in patients with primary central nervous system (CNS) malignancies with NTRK fusion.

    Phase 2
    • To characterize the safety and tolerability of selitrectinib at the recommended Phase 2 dose (RP2D) in patients age 12 years and older and patients age < 12 years.
    • To assess ORR determined by RECIST v1.1, as determined by an IRR in patients with NTRK fusion cancers who have discontinued prior TRK therapy due to intolerance and/or nonresponse
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Ability to understand and the willingness to sign a written informed consent. A signed informed consent must be obtained prior to any study-specific procedures. Parent/guardian of child or adolescent subjects has the ability to understand, agree to, and sign the study Informed Consent Form and applicable Pediatric Assent Form before initiation of any protocol related procedures; subject has the ability to give assent, as applicable, at the time of parental/guardian consent.
    2. Advanced solid tumor for which, in the opinion of the Investigator, no other standard therapy offers greater benefit.
    3. A solid tumor diagnosis in the setting of:
    a. a documented NTRK fusion and a clinical history of relapse following a response to a prior TRK inhibitor
    b. a documented NTRK fusion unresponsive to a prior TRK inhibitor
    c. a documented NTRK fusion and a clinical history of intolerance to a prior TRK inhibitor
    A list of agents with known TRK inhibitor activity is provided in Appendix A. Other agents not listed may also be considered upon Sponsor review. NTRK (NTRK1, NTRK2, and NTRK3) gene fusions will be identified in a CLIA-certified (or equivalently-accredited diagnostic) laboratory. If such a report cannot be provided, other available certifications/accreditations are required and need to be documented. Acceptable methods of detection of NTRK fusion include NGS, fluorescence in situ hybridization (FISH), real-time polymerase chain reaction (RT-PCR) with the following documented in a written report:
    • For NGS, the report indicates that a fusion was detected between an NTRK gene (NTRK1, NTRK2, or NTRK3) and a specific partner gene.
    • For FISH, the report indicates that a probe mapping to an NTRK gene (NTRK1, NTRK2, or NTRK3) and/or a probe mapping to a specific partner gene were found to be colocalized by microscopy.
    • For RT-PCR, the report indicates that a pair of primers targeting an NTRK gene (NTRK1, NTRK2, or NTRK3) on one end and a specific partner gene on the other end amplified a detectable target.
    If enrolling a patient based on the pan-TRK IHC result, documentation of NTRK fusion must be provided using NGS. If enrolling a patient based on FISH result, additional documentation of NTRK fusion using NGS is preferred.
    Exception: Patients with infantile fibrosarcoma (IFS) or congenital mesoblastic nephroma (CMN) may be enrolled based on confirmation of an ETV6 aberration without an identified partner gene (for example, patients may have been diagnosed with IFS or CMN based on an ETV6+ FISH test without identifying [or testing] for NTRK3).
    4. Performance Status: Eastern Cooperative Oncology Group (ECOG) score ≤ 2 (in adults), Karnofsky Performance Status (KPS) ≥ 50% (age ≥ 16 years) or Lansky Performance Score (LPS) ≥ 50% (age < 16 years).
    5. Evaluable and/or measurable disease by RECIST v1.1, RANO or INRC.
    6. Life expectancy of at least 3 months.
    7. At least 1 month of age.
    8. Tissue submission. Samples from 2 time points are required if available.
    a. Tumor sample obtained after patient progression on therapy with last kinase inhibitor with anti TRK activity prior to consenting for this trial. A fresh biopsy in this setting is preferred if it can be safely obtained or this may be an archived sample. See Section 7.6.3 for specifics.
    b. Archived tumor tissue sample obtained prior to when patient started on the first anti-TRK therapy.
    If the site has tissue from both time points, but will only provide tissue from 1 time point, the sample obtained post-progression on the last anti-TRK therapy is preferred. If no tumor tissue samples from either time point are available, the patient may still be eligible with Sponsor approval.
    9. Adequate hematologic function, for patients without known or suspected bone marrow involvement, defined as in Section 4.1
    10. Adequate hepatic function defined as:
    a. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN) or ≤ 5 × ULN if in the setting of liver metastases
    b. Total bilirubin ≤ 1.5 × ULN or ≤ 3 × ULN if in the setting of liver metastases or Gilbert’s disease; patients with higher total bilirubin levels due to Gilbert’s disease or hepatic metastases may be enrolled with Sponsor approval
    11. Patients must have adequate blood clotting, as assessed by the following laboratory requirements to be conducted within 14 days before the first dose of study drug:
    a. International normalized ratio (INR) ≤ 1.5 X ULN
    b. Activated partial thromboplastin time (aPTT) or partial thromboplastin time (PTT) ≤ 1.5 X ULN
    c. Patients on chronic anticoagulation therapy, including direct-acting oral anticoagulants, will be allowed to participate if there is no sign of active bleeding and PT/INR and aPTT or PTT test results are, at the investigator’s discretion, compatible with acceptable benefit-risk ratio
    E.4Principal exclusion criteria
    1. Prior exposure to second generation TRK inhibitor (e.g. selitrectinib, repotrectinib (TPX-0005), taletrectinib (DS-6501b/AB-106)). Exception is in case patient presented intolerance to the second generation TRK inhibitor agent and the duration of exposure was less than 28 days. No previous treatment with selitrectinib is allowed.
    2. If received recent therapy, evidence of moderate-severe/uncontrolled toxicities that in the opinion of the investigator are limiting of subsequent therapy or unstable organ dysfunction due to previous treatment.
    3. Concurrent treatment with a strong CYP3A4 inhibitor or inducer (refer to Appendix B), consumption of grapefruit juice or Seville orange, or drugs associated with QT prolongation. The Investigator should review concomitant medications with their site pharmacist as the list can change frequently.
    4. Clinically significant active cardiovascular disease or history of myocardial infarction within 3 months prior to planned start of selitrectinib, cardiomyopathy; current or known history within the past 6 months of prolonged QT interval corrected for heart rate (QTc interval) > 480 milliseconds. If there is a known explanation for a limited period of a prolonged QT interval (i.e., a medication known to cause prolonged QT interval was administered and has since been discontinued with clearly documented normal QT interval thereafter), that subject may be enrolled. If subject suffers from congestive heart failure, with onset more than 3 months prior to planned start of selitrectinib, then NYHA should be functional capacity I at maximum (Appendix K).
    5. Major surgery within 7 days of enrollment. Catheter placement, endoscopic procedures, and dental surgery are not considered major surgery.
    6. Uncontrolled systemic bacterial, fungal or viral infection. Infections treated with a stable dose of antimicrobial therapy for at least 7 days are allowed. Prophylactic antibiotics are allowed.
    7. Pregnancy or lactation.
    8. Known hypersensitivity to any of the components of the investigational agent, selitrectinib or Ora Sweet® SF and OraPlus®, for patients who will take the selitrectinib suspension. Please refer to Appendix H for the complete list of ingredients for Ora-Sweet® SF and Ora-Plus®.
    9. Known history of human immunodeficiency virus (HIV). Refer to Section 4.2 Exclusion Criteria of the protocol for additional details.
    10. Hepatitis B (HBV) or C (HCV) infection. Refer to Section 4.2 Exclusion Criteria of the protocol for additional details.
    11. Any malabsorption condition.
    12. Substance abuse, medical, psychological, or social conditions that may interfere with the patient’s participation in the study or evaluation of the study results.
    E.5 End points
    E.5.1Primary end point(s)
    Phase 1:
    MTD and/or recommended dose for further study of selitrectinib in patients age 12 years and older and age < 12 years.

    Phase 2: ORR as determined by IRR using RECIST v1.1 in patients age 12 years and older and age < 12 years with documented NTRK fusion cancers and demonstration of progression following (or during receipt of) previous treatment with a TRK inhibitor.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Phase 1:
    Every cohort from baseline until disease progression, unacceptable
    toxicity, patient's withdrawal of consent, or death.

    Phase 2:
    Approximately every 8 weeks for the first 12 cycles, then every 12 weeks while on treatment, and every 12 weeks after the last dose (for up to 2 years) in patients who have not progressed.
    E.5.2Secondary end point(s)
    Phase 1:
    • Incidence, severity, and duration of AEs, including all, serious, and those considered treatment related.
    • Changes from baseline in clinical safety laboratory values and vital signs.
    • ORR as determined by the Investigator, in patients with a documented NTRK fusion cancer previously treated with a TRK inhibitor using RECIST 1.1 for solid tumors.
    • ORR as determined by the treating Investigator using RANO in patients with primary CNS malignancies,.
    • OS: Number of months from the initiation of selitrectinib to the date of death due to any cause.
    • To characterize the PK properties of selitrectinib (Cmax, AUC(0-10), AUC(0-12) and AUC(0-24), if applicable.

    Phase 2:
    • Incidence, severity, and duration of AEs, including all, serious, and those considered treatment related in patients age 12 years and older and age < 12 years.
    • Changes from baseline in clinical safety laboratory values and vital signs.
    • ORR using RECIST v1.1 as determined by an IRR in Cohort 2
    • ORR using RECIST v1.1 or RANO criteria as appropriate by Investigator in Cohort 1 and Cohort 2
    • DOR: Determined for patients with best overall response of confirmed CR or PR by 1) an IRR and 2) the treating Investigator; DOR is defined as the number of months from the start of CR or PR (whichever response is recorded first) and subsequently confirmed to the first date that recurrent or progressive disease is documented, or death.
    • PFS: as determined by an IRR and Investigator.
    • OS
    • CBR: as determined by an IRR and Investigator.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Phase 1:
    PK properties of selitrectinib will be determined between C1D6 and C1D8

    Phase 1 and Phase 2: EORTC QLQ-C30 and EQ-5D or PedsQL should be conducted at the same cycle visits as the disease assessment.
    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 Yes
    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 Yes
    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. trial type description
    Dose escalation
    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 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 EEA10
    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
    Hong Kong
    Korea, Republic of
    United States
    United Kingdom
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last Patient Last Visit
    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 days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days21
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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) Yes
    F. of subjects for this age range: 2
    F.1.1.5Children (2-11years) Yes
    F. of subjects for this age range: 24
    F.1.1.6Adolescents (12-17 years) Yes
    F. of subjects for this age range: 10
    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: 30
    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 Yes
    F. of subjects incapable of giving consent
    Minors until their legal majority age
    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 35
    F.4.2.2In the whole clinical trial 186
    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)
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-06-08
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-01-30
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-2023 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands