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   44201   clinical trials with a EudraCT protocol, of which   7332   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

    Summary
    EudraCT Number:2020-005197-10
    Sponsor's Protocol Code Number:VT3996-202
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-06-09
    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 ConcernedFrance - ANSM
    A.2EudraCT number2020-005197-10
    A.3Full title of the trial
    An Open-Label, Phase 2 Trial of Nanatinostat in Combination with Valganciclovir in Patients with Epstein-Barr Virus-Positive (EBV+) Relapsed/Refractory Lymphomas (NAVAL-1)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Nanatinostat and Valganciclovir in R/R EBV+ Lymphoma (“NAVAL-1”)
    A.3.2Name or abbreviated title of the trial where available
    NAVAL-1
    A.4.1Sponsor's protocol code numberVT3996-202
    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 SponsorViracta Therapeutics, 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 supportViracta Therapeutics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationViracta Therapeutics, Inc.
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street Address2533 S. Coast Hwy 101, Suite 210
    B.5.3.2Town/ cityCardiff
    B.5.3.3Post codeCA 92007
    B.5.3.4CountryUnited States
    B.5.6E-mailclinicaltrials@viracta.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 nameNanatinostat
    D.3.2Product code VRx-3996
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNNanatinostat
    D.3.9.1CAS number 1256448-47-1
    D.3.9.2Current sponsor codeVRx-3996
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 Yes
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameValganciclovir
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNVALGANCICLOVIR
    D.3.9.1CAS number 175865-60-8
    D.3.9.4EV Substance CodeSUB00007MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number450
    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 Yes
    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 nameganciclovir
    D.3.4Pharmaceutical form Powder for concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGANCICLOVIR SODIUM
    D.3.9.1CAS number 107910-75-8
    D.3.9.4EV Substance CodeSUB02312MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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
    Epstein-Barr Virus-Positive (EBV+) Relapsed/Refractory Lymphomas
    E.1.1.1Medical condition in easily understood language
    Epstein-Barr Virus-Positive (EBV+) Relapsed/Refractory Lymphomas
    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 PT
    E.1.2Classification code 10071441
    E.1.2Term Epstein-Barr virus associated lymphoma
    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
    To evaluate the anti-tumor activity of the combination treatment of nanatinostat (Nstat) with valganciclovir (VGCV) based on objective tumor response rates
    E.2.2Secondary objectives of the trial
    To determine the duration of tumor control
    To determine survival outcomes
    To describe the safety profile of the combination treatment of Nstat with VGCV
    To generate pharmacokinetic (PK) data with the intended commercial dose and administration of Nstat

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adult patients age ≥18 years at the time of informed consent.
    2. Histologically confirmed (by 2016 WHO classification) EBV+ lymphoma* per local laboratory by EBER-ISH (or for PTLD only, by LMP-1 immunohistochemistry) on a representative disease specimen. Any degree of EBER-ISH or LMP-1 positivity is considered to be eligible (ie, there is no cut-off value for % positive cells).
    * Tumor cells are EBV+, with the exception of AITL, which is characterized by EBV-negative neoplastic T cells and EBV+ associated B-lineage cells (of immunoblastic/plasmablastic immunophenotype)
    a. A recent FFPE specimen must be available for central review. The specifications for the age of the tumor samples are:
    •For patients with ENKTL, AITL, PTLD and HIV-L: preferably ≤1 year old. For tumor specimens >1 year old, please consult the Medical Monitor to discuss eligibility.
    •For patients with all other lymphoma subtypes: preferably ≤6 months old. For tumor specimens >6 months old, please consult the Medical Monitor to discuss eligibility.
    3. For ENKTL patients only: Relapsed or refractory* disease following 1 or more prior systemic therapies with a curative intent. Patients must have failed an asparaginase-containing regimen.
    4. For non-ENKTL patients only: Relapsed or refractory* disease following 2 or more prior systemic therapies with a curative intent, with the following specifications:
    a. For EBV+ DLBCL, NOS: Patients must have received at least one course of an anti CD20 immunotherapy such as rituximab, and at least one course of anthracycline-based chemotherapy (unless contraindicated due to cardiac dysfunction, in which case, an accepted anthracycline-free alternative for DLBCL was given).
    b. For PTLD: Patients must have received immunotherapy with an anti-CD20 agent.
    c. For HL: Patients must have received at least one course of anthracycline-based chemotherapy (unless contraindicated due to cardiac dysfunction).
    *Patients are considered to have refractory disease if they had no response (ie, no CR or PR), or a response lasting <6 months to a prior systemic therapy.
    5. Patients with the following lymphomas associated with HIV infection (HIV-L): plasmablastic, Burkitt, Hodgkin lymphoma and DLBCL.
    6. Patients with HIV-L should meet defined criteria for inclusion
    7. No available standard therapies in the opinion of the Investigator.
    8. Not eligible for high-dose chemotherapy with allogeneic/autologous stem cell transplantation or CAR-T therapy at the time of study entry.
    9. Presence of at least one bi-dimensionally measurable lesion by CT or MRI: longest diameter (LDi) >1.5 cm for a nodal lesion; LDi >1.0 cm for an extranodal lesion within 28 days prior to start of treatment.
    10. Able to provide a core or excisional lymph node biopsy for biomarker analysis from an archival biopsy at screening.
    11. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.
    12. All acute toxic effects of any prior anti-tumor therapy resolved to Grade ≤1 before initiation of study treatment (excluding alopecia and stable Grade 2 sensory neuropathy).
    13. Required baseline laboratory data (within 2 weeks prior to start of study drug administration) as shown in the protocol
    14. Life expectancy >3 months.
    15. Women of childbearing potential (ie, reached menarche, and not post-menopausal [(no menses for 12 months without an alternative medical cause) or surgically sterile]) must have the following:
    a. Understand that the study medication is expected to have teratogenic risk.
    b. Have a negative serum beta human-chorionic gonadotropin (β-hCG) pregnancy test at screening.
    c. Commit to continued abstinence from heterosexual intercourse (excluding periodic abstinence or the withdrawal method) or begin a highly effective method of birth control with a Pearl-Index <1%, without interruption, throughout the study dosing period and for 6 months after the last dose of nanatinostat. Apart from abstinence, highly effective methods of birth control include the following:
    I. Combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal).
    ii. Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable).
    iii. Intrauterine device (IUD).
    iv. Intrauterine hormone-releasing system (IUS).
    v. Bilateral tubal occlusion.
    vi. Vasectomized partner.
    16. Male patients must agree to use condoms during intercourse throughout the study dosing period and for 90 days after the last dose of nanatinostat. Female partners of male patients participating in the study are to consider the use of effective methods of contraception while their partner is treated on study and for 90 days after the last administration of nanatinostat.
    17. The patient is willing and able to provide informed consent and comply with the protocol.
    E.4Principal exclusion criteria
    1. Presence or history of central nervous system (CNS) involvement by lymphoma.
    2. Systemic anticancer therapy within 21 days prior to Cycle 1 Day 1 dosing.
    3. Antibody (anticancer) agents within 28 days of Cycle 1 Day 1 dosing.
    4. Less than 14 days from prior local site radiation therapy.
    5. Less than 60 days from prior autologous hematopoietic stem cell or solid organ transplant.
    6. Less than 21 days from prior CAR-T therapy (any AEs must be grade 1 or less for enrollment).
    7. Less than 90 days from prior allogeneic transplant.
    8. Receiving systemic corticosteroids during the last week prior to Cycle 1 Day 1, unless administered at a dose equivalent to ≤20 mg/day of prednisone.
    9. For recipients of prior allogeneic HSCT: Receiving systemic immunosuppressants as either prophylaxis or treatment for GVHD.
    10. Major surgery within 28 days within the first dose of study drug. In case of recent major surgery, the patient must have recovered adequately from the procedure and/or any complications prior to starting study treatment.
    Note: Minor surgery (eg, minor biopsy of extracranial site, central venous catheter placement, shunt revision) is permitted within 3 weeks prior to enrollment.
    11. Is currently participating in or has participated in an interventional study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.
    •Note: Individuals who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks since the last dose of the previous investigational agent.
    12. History of previously treated cancer except for the following:
    a. Adequately treated:
    - local basal cell or squamous cell carcinoma of the skin, or related localized non melanoma skin cancer.
    - cervical carcinoma in situ.
    - superficial bladder cancer.
    - localized prostate cancer undergoing surveillance or previously fully resected.
    - localized breast cancer treated with surgery and/or radiotherapy and/or endocrine therapy, but not including systemic chemotherapy.
    - other adequately treated Stage 1 or 2 cancer currently in complete remission.
    13. Inability to take oral medication, malabsorption syndrome or any other gastrointestinal condition (nausea, diarrhea, vomiting) that may impact the absorption of nanatinostat and valganciclovir.
    14. Active graft-versus-host disease (GvHD).
    15. Positive hepatitis B core antibody or surface antigen unless quantitative DNA polymerase chain reaction (PCR) is negative, and patient will be receiving prophylaxis for reactivation.
    16. Positive hepatitis C virus on RNA PCR.
    17. Known SARS-CoV-2 positivity.
    18. History of allergic reactions attributed to compounds of similar chemical or biologic composition to valganciclovir or nanatinostat.
    19. Active infection requiring systemic therapy (excluding viral upper respiratory tract infections). Patients may be receiving prophylactic antiviral, antifungal or antibacterial therapies at the discretion of the Investigator.
    20. Prolongation of corrected QT interval using Fridericia’s formula (QTcF) to >480 msec, requires the coadministration of drugs known to prolong QT (Class Ia [disopyramide, quinidine, procainamide] and Class III [sotalol, dofetilide, ibutilide] antiarrhythmic agents), and/or has a history of Torsades de Pointes (TdP).
    21. Receiving concomitant drugs that are inhibitors of P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP; unless they can be held for 2 weeks or 5 half-lives, whichever is longer), prior to administration of nanatinostat.
    22. Psychiatric illness/social situations/substance abuse disorder that would interfere with compliance with study requirements.
    23. Has a prior or ongoing clinically significant illness, medical condition, physical finding, electrocardiogram (ECG) finding, or laboratory abnormality that, in the Investigator’s opinion, could affect the safety of the patient, impair the assessment of study results, interfere with the patient’s participation for the full duration of the study, or is not in the best interest of the patient to participate.
    24. Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the Screening visit through 6 months after the last dose of nanatinostat.
    E.5 End points
    E.5.1Primary end point(s)
    • Objective response rate (ORR) as assessed by an Independent Review Committee (IRC) – defined as the proportion of patients who achieve a complete response (CR) or partial response (PR) using the 2007 International Working Group (IWG) criteria.

    The Investigator will also use the 2007 IWG criteria for assessment of progression/relapse and for any clinical decisions requiring assessment of disease progression/relapse.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary efficacy endpoint is ORR assessed by an IRC. Disease response assessments will be made every 8 weeks until 24 weeks, and then every 12 weeks for the remainder of the study, according to the revised response criteria for malignant lymphoma based on the IWG-NHL guidelines.
    PET/CT scans (or MRI if a CT with contrast is contraindicated) will be performed at baseline, and for the 8-week and 16-week tumor assessments only [for combination therapy]. Subsequent evaluations will be by CT with contrast (without PET) or MRI only. Efficacy will be evaluated in terms of ORR, DOR, PFS, OS, TTP, and TTNT. ORR will be used to move from Stage 1 to Stage 2.
    E.5.2Secondary end point(s)
    • Duration of response (DOR) – defined as the interval from the date of first observed CR or PR to the date of disease progression, death due to any cause, or last adequate (radiographic) response assessment.
    • Time to next anti-lymphoma treatment (TTNLT) – defined as the interval from the start of study drug treatment to date of next anti-lymphoma treatment.
    • Progression-free survival (PFS) – defined as the interval from the start of study drug treatment to the date of first documented disease progression or death from any cause, whichever occurs first.
    • Time to progression (TTP) – defined as the interval from the start of study drug treatment to date of disease progression.
    • Overall survival (OS) – defined as the interval from the start of study drug treatment to date of death, for any reason.
    • Incidence and severity of treatment-emergent adverse events (TEAEs). Adverse events will be graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
    • Pharmacokinetic (PK) parameters (eg, time to maximum plasma concentration [tmax], maximum plasma concentration [Cmax], area under the plasma concentration-time curve [AUC]).

    E.5.2.1Timepoint(s) of evaluation of this end point
    Overall survival,Time to next anti-lymphoma treatment, Duration of response, Progression free survival
    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 No
    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) No
    E.7.1.1First administration to humans No
    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 Yes
    E.8.1.7.1Other trial design description
    basket design study
    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.8.2.4Number of treatment arms in the trial8
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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
    Korea, Republic of
    Singapore
    Taiwan
    United States
    France
    Germany
    Italy
    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
    The end of the study occurs when all patients have either progressed, discontinued, died, become lost to follow-up, or have maintained a CR, PR, or SD for at least 3 years, or when the trial is terminated by the Sponsor.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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: 112
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 38
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 68
    F.4.2.2In the whole clinical trial 150
    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)
    Patients continuing to derive benefit from study treatment in the opinion of the Investigator at the end of the study may be able to continue receiving study drugs on an individual basis (eg, by separate protocol or post-trial access plan) with Sponsor approval.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-08-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-07-16
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
    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 © 1995-2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA