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    Summary
    EudraCT Number:2018-000023-13
    Sponsor's Protocol Code Number:AVA-CIT-330
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-09-21
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2018-000023-13
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled Study With an Open-Label
    Extension to Evaluate the Efficacy and Safety of Avatrombopag for the Treatment of
    Chemotherapy-Induced Thrombocytopenia in Subjects With Active Non-Hematological Cancers
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to Evaluate the Efficacy and Safety of Avatrombopag for the Treatment of
    Chemotherapy-Induced Thrombocytopenia in Subjects With Active Non-Hematological Cancers
    A.4.1Sponsor's protocol code numberAVA-CIT-330
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03471078
    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 SponsorSobi, 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 supportSobi Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSobi, Inc.
    B.5.2Functional name of contact pointClinical Development
    B.5.3 Address:
    B.5.3.1Street Address890 Winter Street, Suite 200
    B.5.3.2Town/ cityWaltham
    B.5.3.3Post codeMA 02451
    B.5.3.4CountryUnited States
    B.5.4Telephone number+19193387938
    B.5.5Fax number+19193385976
    B.5.6E-mailnaclinical@sobi.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 nameavatrombopag
    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 INNAvatrombopag maleate
    D.3.9.1CAS number 677007-74-8
    D.3.9.3Other descriptive nameAVATROMBOPAG MALEATE
    D.3.9.4EV Substance CodeSUB120722
    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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chemotherapy-Induced Thrombocytopenia in Subjects With Active Non-Hematological Cancers
    E.1.1.1Medical condition in easily understood language
    Low platelet counts
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10043555
    E.1.2Term Thrombocytopenias
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10043554
    E.1.2Term Thrombocytopenia
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 22.1
    E.1.2Level LLT
    E.1.2Classification code 10039884
    E.1.2Term Secondary thrombocytopenia
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10024922
    E.1.2Term Low platelets
    E.1.2System Organ Class 100000004848
    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 efficacy of avatrombopag in increasing platelet counts and therefore preventing the need for a platelet transfusion or chemotherapy dose
    reduction or delay in subjects with CIT.
    E.2.2Secondary objectives of the trial
    • To evaluate the safety of avatrombopag in subjects with CIT, and
    • To investigate the effect of avatrombopag on bleeding in subjects with CIT.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects who meet all of the following criteria will be eligible to participate in the study:
    1. Subject is ≥18 years of age at the time of informed consent;
    2. Subject with a diagnosis with ovarian cancer, lung cancer (small cell or non-small cell), or bladder cancer, requiring systemic chemotherapy;
    3. Subject is currently receiving a chemotherapy regimen given in a 21-day or 28-day cycle (other chemotherapy cycle lengths are not allowed), including 1 or more of the following agents or class of agents:
    -Nucleoside analog, including gemcitabine and fluorouracil;
    -Carboplatin or cisplatin;
    -Anthracycline; or
    -Alkylating agent;
    4. Subject experienced severe thrombocytopenia, defined as 2 platelet counts <50 × 109/L measured at least 24 hours apart, during the qualifying chemotherapy cycle (Cycle X), of their current chemotherapy regimen. Platelet counts obtained per standard of care during Cycle X prior to consent may be used;
    5.Subject is planned to receive the same chemotherapy regimen and the same dose(s) on Chemotherapy Day (Days 1-3) of Cycle X+1 as was given in the qualifying chemotherapy Cycle X;
    6. Subject has an Eastern Cooperative Oncology Group (ECOG) performance status ≤2;
    7. Subject has a life expectancy >12 weeks at Screening and is able to receive at least 2 additional cycles of the current chemotherapy regimen;
    8. Females of childbearing potential must agree to use a highly effective method of contraception (eg, total abstinence; an intrauterine device; hormonal contraceptive given orally, by injection, or by implant; double barrier contraception (i.e., condom + diaphragm); or has a vasectomized
    partner with confirmed azoospermia) throughout the entire study period and for 30 days after investigational product (IP) discontinuation. If currently abstinent, the subject must agree to use an effective method as described above if she becomes sexually active during the study period or for 30 days after IP discontinuation. Male subjects must be either surgically sterile or agree to use a double barrier contraception method (combination of male condom with either cap, diaphragm, or sponge with a spermicide) throughout the entire study period and for 30 days after IP discontinuation;
    9. Subject is willing and able to comply with all aspects of the protocol; and
    10. Subject must provide written informed consent.
    Inclusion Criteria for Subjects to Continue Into the Optional Open-Label Extension Period
    Subjects who meet all of the following criteria will be eligible to continue into the optional
    Open-Label Extension (OLE) Period:
    1. Subject is currently receiving the same chemotherapy agents as were given in the qualifying chemotherapy Cycle X;
    2. Subject has an ECOG performance status ≤2;
    3. Females of childbearing potential must agree to use a highly effective method of contraception as previously defined.
    Male subjects must be either surgically sterile or agree to use a double barrier contraception method (combination of male condom with either cap, diaphragm, or sponge with a spermicide) throughout the entire study period and for 30 days after IP discontinuation;
    4. Subject is willing and able to comply with all aspects of the protocol; and
    5. Subject must provide consent to continue into the OLE Period.
    E.4Principal exclusion criteria
    1. Subject has experienced ≥ Grade 2 CIT with a platelet count <75 × 10^9/L (other than during the current chemotherapy treatment regimen) within 6 months of Screening;
    2. Subject has a platelet count >175 × 10^9/L at Visit 2 (-1 day);
    3. Subject with any history of hematologic malignancies, including leukemia, myeloma, myeloproliferative disease, lymphoma, or myelodysplastic diseases;
    4. Subject who received >2 previous lines of chemotherapy (adjuvant/neoadjuvant therapy is considered a previous line; immunotherapy alone is not considered a previous line) or is receiving whole brain radiation during the study treatment period;
    5. Subject with an alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >5 × upper limit of normal or total bilirubin ≥3 × upper limit of normal;
    6. Subject has a known medical history of human immunodeficiency virus;
    7. Subject has any known clinically significant acute or active bleeding (eg, gastrointestinal or central nervous system) within 7 days of Screening;
    8. Subject has a known medical history of genetic prothrombotic syndromes (eg, Factor V Leiden, prothrombin G20210A, or ATIII deficiency);
    9. Subject has a recent history (within 3 months of Screening) of significant cardiovascular disease (eg, congestive heart failure exacerbation, arrhythmia known to increase the risk of thromboembolic events [eg, atrial fibrillation], coronary artery stent placement, angioplasty, or coronary artery bypass graft);
    10. Subject has a history of arterial or venous thrombosis within 3 months of Screening;
    11. Subject has used vitamin K antagonists within 7 days of Screening (use of low molecular weight heparin, Xa inhibitors, or thrombin inhibitors is allowed);
    12. Subject has a history of chronic platelet or bleeding disorders or thrombocytopenia due to an etiology other than CIT (eg, chronic liver disease or immune thrombocytopenia purpura);
    13. Subject has used moderate or strong inducers of cytochrome P450 (CYP)2C or CYP3A4/5 within 7 days of Screening;
    14. Subject has received a thrombopoietin receptor agonist (eg, eltrombopag or romiplostim) or recombinant human thrombopoietin for the treatment of CIT within 3 months of Screening;
    15. Subject received a platelet transfusion within 72 hours of randomization;
    16. Subject is unable to take oral medication;
    17. Subject has any history of a concomitant medical condition that, in the opinion of the Investigator, would compromise the subject’s ability to safely complete the study, such as unstable angina, renal failure requiring hemodialysis, or active infection requiring intravenous antibiotics;
    18. Female subjects who are lactating or pregnant at Screening or the Baseline Visit (as documented by a positive serum or urine beta-human chorionic gonadotropin [β-hCG] test);
    19. Subject has hypersensitivity to avatrombopag or any of its excipients; or
    20. Subject is currently enrolled in another clinical study with any investigational drug or device within 30 days of Screening; however, participation in observational studies is permitted.
    Exclusion Criteria for Subjects to Continue Into the Optional Open-Label Extension Period Subjects who meet any of the following criteria will be excluded from continuing into the optional OLE Period:
    1. Subject has a platelet count >175 × 10^9/L on the scheduled first day of dosing of avatrombopag prior to chemotherapy;
    2. Subject with an alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >5 × upper limit of normal or total bilirubin ≥3 × upper limit of normal;
    3. Subject has any known clinically significant acute or active bleeding (eg, gastrointestinal or central nervous system) within 7 days of pre-chemotherapy IP treatment in OLE cycles;
    4. Subject has used vitamin K antagonists within 7 days of pre-chemotherapy IP treatment in Cycle X + 3 (use of low molecular weight heparin, Xa inhibitors, or thrombin inhibitors is allowed);
    5. Subject has used moderate or strong inducers of CYP2C or CYP3A4/5 within 7 days of pre-chemotherapy IP treatment in OLE cycles;
    6. Subject is unable to take oral medication;
    7. Female subjects who are lactating or pregnant (as documented by a positive urine or serum test)
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the proportion of responders who meet all of the following criteria during the period after post-chemotherapy IP treatment in Cycle X+1 through Chemotherapy Day of Cycle X+2:

    • Not requiring a platelet transfusion;
    • Not requiring a chemotherapy dose reduction by ≥15% due to thrombocytopenia; and
    • Not requiring a chemotherapy delay by ≥4 days due to thrombocytopenia.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Cycle X+2
    E.5.2Secondary end point(s)
    • Duration of severe thrombocytopenia defined as a platelet count <50 × 109/L during the period after post-chemotherapy IP treatment in Cycle X+1 through Chemotherapy Day of Cycle X+2;
    • Change in platelet count from baseline (qualifying chemotherapy cycle [Cycle X]) (nadir) to Cycle X + 1 (nadir);
    • Proportion of subjects who do not have major or non-major clinically relevant bleeding during the period after post-chemotherapy IP treatment in Cycle X+1 through Chemotherapy Day of Cycle X+2; and
    • Proportion of subjects who do not receive platelet transfusion during the period after postchemotherapy IP treatment in Cycle X+1 through Chemotherapy Day of Cycle X+2.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Cycle X + 1
    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 Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA13
    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
    Russian Federation
    Serbia
    Ukraine
    United States
    Hungary
    Poland
    E.8.7Trial has a data monitoring committee Yes
    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 study (“study completion”) is defined as the date of the last protocol-specified visit/assessment (including telephone contact) for the last subject in the Long-Term Follow-Up Period.
    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 months10
    E.8.9.1In the Member State concerned days17
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days8
    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: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 43
    F.4.2.2In the whole clinical trial 120
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Standard care
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-10-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-09-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-02-15
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