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    Summary
    EudraCT Number:2018-001701-82
    Sponsor's Protocol Code Number:XYN-601
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2019-02-01
    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 ConcernedGreece - EOF
    A.2EudraCT number2018-001701-82
    A.3Full title of the trial
    Open-label, Single-Arm, Phase 2 Study of Oral HDAC-inhibitor Abexinostat in Patients with Relapsed or Refractory Follicular Lymphoma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase 2 clinical trial designed to investigate the safety and effectiveness of the investigational product Abexinostat, in patients with relapsed or refractory Follicular Lymphoma.
    All subjects will receive the study drug Abexinostat.
    A.4.1Sponsor's protocol code numberXYN-601
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03600441
    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 SponsorXynomic Pharmaceuticals, 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 supportXynomic Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPPD
    B.5.2Functional name of contact pointProject Management
    B.5.3 Address:
    B.5.3.1Street Address3900 Paramount Parkway
    B.5.3.2Town/ cityMorrisville
    B.5.3.3Post codeNC 27560
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1910558 5264
    B.5.5Fax number+1224358 1981
    B.5.6E-mailDaniel.Zamfir@ppdi.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 nameAbexinostat
    D.3.2Product code PCI-24781 / S-78454
    D.3.4Pharmaceutical form 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 INNAbexinostat
    D.3.9.2Current sponsor codePCI-24781-38
    D.3.9.3Other descriptive nameS 78454-2
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Follicular Lymphoma
    E.1.1.1Medical condition in easily understood language
    Follicular Lymphoma is a condition where the body makes abnormal B-Lymphocytes (a type of white blood cell) and these abnormal
    lymphocytes (known as lymphoma) build up in the lymph nodes.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10080213
    E.1.2Term In situ follicular lymphoma
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to evaluate the clinical efficacy of abexinostat in patients with relapsed/refractory follicular lymphoma based on the objective response rate (ORR).
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study include the following:
    - To evaluate the duration of response (DOR) in patients with elapsed/refractory
    follicular lymphoma treated with abexinostat.
    - To evaluate the progression free survival (PFS) in patients with relapsed/refractory follicular lymphoma treated with abexinostat.
    - To evaluate the clinical benefit rate (CBR) in patients with relapsed/refractory follicular lymphoma treated with abexinostat.
    - To evaluate the overall survival (OS) in patients with relapsed/refractory treated with abexinostat.
    - To characterize the safety and tolerability of abexinostat in patients with relapsed/refractory follicular lymphoma.
    - To investigate the pharmacokinetics and pharmacodynamics of abexinostat in patients with relapsed/refractory follicular lymphoma.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Each patient must meet all of the following criteria to be enrolled in this study:
    1. Is male or female aged 18 years or older
    2. Is able to understand and voluntarily sign an informed consent document before any study related assessments/procedures are conducted
    3. Has histologically confirmed Grade 1, 2, or 3a follicular lymphoma
    4. Has undergone at least 3 prior systemic lines of therapy for their follicular lymphoma, which included an anti-CD20 antibody and cytotoxic therapy
    5. Has follicular lymphoma that has relapsed after (progressed after 6 months from the start of therapy) or is refractory to the last line of therapy (no response or progression within 6 months from the start of therapy) and needs treatment (must have at least 1 lymph node or extranodal lymphoid malignancy measuring ≥ 3 cm in its longest diameter)
    6. Has radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined as the presence of ≥ 1 lesion that measures ≥ 3 cm in the longest diameter) as assessed by computed tomography or magnetic resonance imaging
    7. Has Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
    8. Has adequate hematologic function as defined by:
    a. Absolute neutrophil count > x1E+09
    b. Hemoglobin ≥ 8 g/dL
    c. Platelet count > 75 ×1E+09
    9. Has adequate renal function as defined by creatinine clearance ≥ 30 mL/min
    10. Has adequate hepatic function as defined by:
    a. AST and ALT < 1.5 × upper limit of normal (ULN)
    b. Total bilirubin < 1.5 × ULN
    11. Female patients must fulfil the following criteria:
    a. Be of non-childbearing potential, defined as follows:
    i. Postmenopausal (ie, ≥ 1 year without any menses) prior to Screening, or
    ii. Documented surgically sterile (≥ 1 month prior to Screening)
    b. If of childbearing potential:
    i. Agree not to try to become pregnant during the study and for 90 days after the last dose
    ii. Have a negative pregnancy test at Screening, and
    iii. If heterosexually active, agree to consistently use 2 different forms of highly effective birth control (at least 1 of which must be a barrier method) starting at Screening and continuing throughout the study until after 90 days after the last dose
    c. Use highly effective forms of birth control (women of childbearing potential only), which include the following:
    i. Consistent and correct use of established oral contraception
    ii. Established intrauterine device or intrauterine system
    iii. Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository
    12. Female patients must agree not to breastfeed starting from the time of Screening, throughout the study, and until after 90 days following the last dose
    13. Male patients and their female spouse/partners who are of childbearing potential must use highly effective contraception methods consisting of 2 forms of birth control (at least 1 of which must be a barrier method) from the time of Screening, throughout the study, and until after 90 days following the last dose
    14. Male patients must agree not to donate sperm starting from the time of Screening, throughout the study, and until after 90 days following the last dose
    E.4Principal exclusion criteria
    Patients meeting any of the following criteria will be excluded from the study:
    1. Has histologically confirmed diagnosis of Grade 3b follicular lymphoma, or transformation to diffuse large B cell lymphoma. In patients with clinical suspicion of transformed disease, a fresh biopsy is recommended.
    2. Has a history of central nervous system lymphoma (either primary or secondary).
    3. Has had prior treatment with abexinostat.
    4. Has had allogeneic stem cell transplant within the last 6 months, or autologous stem cell transplant within the last 3 months before enrollment.
    5. Has active graft-versus-host disease.
    6. Has used prohibited medication (Section 5.7 and Section 5.8) within 7 days or
    5 half-lives, whichever is shorter, prior to first dose of study drug.
    7. Has evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection or risk of reactivation: HBV DNA and HCV RNA must be undetectable. Patients cannot be positive for hepatitis B surface antigen (HBsAg) or anti hepatitis B core antibody. Patients who have positive antibodies against HBsAg as the only evidence of prior exposure may participate in the study provided that there is both:
    a. no known history of HBV infection, and
    b. verified receipt of hepatitis B vaccine
    8. Is taking corticosteroids during the last 1 week prior to Cycle 1 Day 1, unless administered at a dose equivalent to < 20 mg/day prednisone (over this 1 week).
    9. Has not recovered from a major surgical intervention.
    10. Is a female who is currently pregnant, breastfeeding, or planning to become pregnant or to breastfeed within 90 days of the last dose of study drug.
    11. Has any of the following types of cardiac impairment at the time of enrollment:
    a. New York Heart Association Class III or IV heart disease
    b. Uncontrolled angina, congestive heart failure, or myocardial infarction within 6 months prior to enrollment
    c. QTc interval prolongation based on Fridericia’s formula (> 450 ms in males, > 470 ms in females)
    12. Has received any investigational medication within 30 days or 5 half-lives prior to Day 1, whichever is longer.
    13. Has prior history of malignancies, other than follicular lymphoma, unless the patient has been free of the disease for ≥ 3 years. Exceptions include localized prostate cancer that is being managed with active surveillance or a history of previously treated:
    a. Localized non-melanoma skin cancer
    b. Carcinoma in situ of the cervix
    E.5 End points
    E.5.1Primary end point(s)
    Objective response defined as complete response (CR) or partial response (PR according to the Lugano 2014 criteria as determined by an Independent Review Committee (IRC).
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of Cycle 2 or until patient no longer receive benefits or tolerates regimen
    E.5.2Secondary end point(s)
    1. Duration of response using the Lugano 2014 criteria
    Duration of response defined as the time from first documented evidence of CR or PR until disease progression or death from any cause among patients who achieve an objective response, according to the Lugano 2014 criteria as determined by an IRC.
    2. Duration of response using the RECIL 2017
    Defined as the time from first documented evidence of CR or PR from any cause among patients who achieve an objective response, according to the RECIL 2017 as determined by an IRC. Duration of response will be evaluated once more using the RECIL 2017 with the inclusion of MR (Minor Response) lasting ≥ 6 months.
    3. Progression free survival
    Defined as the time from the start of treatment until disease progression or death assessed using the Lugano 2014 criteria AND RECIL 2017 as determined by an IRC.
    4. Clinical Benefit
    Defined as the best from CR, PR, or stable disease (SD) observed at the end of cycle 2 or later, according to the Lugano 2014 criteria AND RECIL 2017 as determined by an IRC.
    5. Objective response
    Defined as CR or PR observed at the end of Cycle 2 or later according to the International Working Group consensus response evaluation criteria in lymphoma (RECIL 2017) as determined by an IRC. Objective response will be evaluated once more using the RECIL 2017 with the inclusion of minor response (MR) lasting ≥ 6 months.
    6. Overall survival
    Defined as the time from the start of treatment until death from any cause or last contact.
    7. Safety
    Safety as measured by the incidence, severity, seriousness and relatedness of the treatment-emergent adverse events to study drug.
    8. Change in the QTc interval Change from baseline in the QTc interval.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1,2. Time Frame: from first documented evidence of CR or PR until disease progression or death
    3. Time Frame: start of the treatment or until disease progression or death
    4. Time Frame: from CR, PR, or stable disease (SD) observed at the end of cycle 2 or later or until disease progression or death
    5. Time Frame: end of Cycle 2 or later or until disease progression or death
    6. Time Frame: Day 1 until death
    7. Time Frame: End of Cycle 2 or later or until disease progression or death
    8. Time Frame: End of Cycle 2 or later or until disease progression or death
    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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA28
    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
    Belarus
    France
    Greece
    Hungary
    Italy
    Russian Federation
    Spain
    United States
    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 the study is defined as the date on which the last patient completes their last follow up visit.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months9
    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: 95
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 44
    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 No
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 103
    F.4.2.2In the whole clinical trial 139
    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)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-04-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-02-22
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2019-12-03
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