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    Summary
    EudraCT Number:2018-000062-11
    Sponsor's Protocol Code Number:INCB59872-103
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2018-06-26
    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 ConcernedUK - MHRA
    A.2EudraCT number2018-000062-11
    A.3Full title of the trial
    An Open-Label Phase 1b Study of the Safety, Tolerability, and Preliminary Antitumor Activity of INCB059872 in Participants With Relapsed or Refractory Ewing Sarcoma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical research Study to find out if the study drug INCB059872 is safe and effective in people who have Ewing sarcoma.
    A.4.1Sponsor's protocol code numberINCB59872-103
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03514407
    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 SponsorIncyte Corporation
    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 supportIncyte Corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIncyte Corporation
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street Address1801 Augustine Cut-Off
    B.5.3.2Town/ cityWilmington
    B.5.3.3Post codeDE19803
    B.5.3.4CountryUnited States
    B.5.5Fax number13024252734
    B.5.6E-mailRA@incyte.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.3.2Product code INCB059872
    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 INNNot yet available
    D.3.9.1CAS number 1802909-49-4
    D.3.9.3Other descriptive nameINCB059872
    D.3.9.4EV Substance CodeSUB187367
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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
    Relapsed or Refractory Ewing Sarcoma
    E.1.1.1Medical condition in easily understood language
    Ewing sarcoma
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10015560
    E.1.2Term Ewing's sarcoma
    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
    To evaluate the safety and tolerability of INCB059872 in participants with relapsed/refractory Ewing sarcoma.
    E.2.2Secondary objectives of the trial
    - To evaluate the antitumor activity of INCB059872 in participants with relapsed/refractory Ewing sarcoma, endpoint: ORR.
    - To evaluate the PK of INCB059872.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. The participant (or legally acceptable representative if applicable) provides written informed consent for the study.
    2. The participant must be 12 years of age or older, at the time of signing the informed consent.
    3. Have histologically or cytologically confirmed diagnosis of Ewing sarcoma and have progressed on or after standard therapies.
    4. The participant must not be a candidate for potentially curative therapy or standard-of-care approved therapy.
    5. Have measurable disease by CT or MRI based on RECIST 1.1 as determined by site radiology.
    6. ECOG performance status 0 to 2.
    7. Baseline archival tumor specimen available or if an archived sample is not available, a predose core tumor biopsy will be required in order to enter the study. Archived specimens must be an FFPE tumor block with sufficient tumor for 15 consecutive sections or 15 unstained slides from biopsy or resection of primary tumor that is preferably ≤ 1 year old and obtained after completion of last treatment. Fine needle aspiration and/or brushing biopsy are not acceptable. If a fresh biopsy is not feasible, discuss with sponsor medical monitor.
    8. Willingness to avoid pregnancy or fathering children based on the criteria below.
    a. Male participants must agree to take appropriate precautions to avoid fathering children (with at least 99% certainty) from screening through 90 days after the last dose of study drug(s) and refrain from donating sperm during this period. Permitted methods that are at least 99% effective in preventing pregnancy should be communicated to the participant and their understanding confirmed.
    b. Woman of nonchildbearing potential (ie, surgically sterile with a hysterectomy and/or bilateral oophorectomy OR ≥ 12 months of amenorrhea).
    c. Woman of childbearing potential who has a negative serum pregnancy test at screening and negative urine pregnancy test before the first dose on Day 1 and who agrees to take appropriate precautions to avoid pregnancy (with at least 99% certainty) from screening through safety follow-up. Permitted methods that are at least 99% effective in preventing pregnancy should be communicated to the participant and their understanding confirmed.
    E.4Principal exclusion criteria
    1. Receipt of anticancer medications, anticancer therapies, or investigational drugs within the following interval before the first administration of study drug (requirement may be waived with medical monitor approval):
    a. < 6 weeks for mitomycin or nitrosoureas.
    b. < 5 half-lives or 14 days, whichever is longer, for any investigational agent (for any indication).
    c. < 5 half-lives for all other anticancer medications (unless approved by sponsor).
    d. < 4 weeks for immunotherapy or antibody therapy.
    2. Participants must have recovered (≤ Grade 2 or at pretreatment baseline) from AEs from previously administered therapies except for stable chronic toxicities (≤ Grade 2) not expected to resolve.
    3. Concurrent anticancer therapy (eg, chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, hormonal therapy, investigational therapy, or tumor embolization).
    4. Untreated brain or CNS metastases or brain/CNS metastases that have progressed (eg, evidence of new or enlarging brain metastasis or new neurological symptoms attributable to brain/CNS metastases). Participants with previously treated and clinically stable brain/CNS metastases who are receiving concomitant corticosteroids must be on a stable or decreasing dose for at least 2 weeks (equivalent to ≤ 10 mg/day) or off of all corticosteroids for at least 2 weeks before the first dose of study treatment.
    5. Prior radiotherapy within 2 weeks of study treatment. Participants must have recovered from all radiation-related toxicities, including radiation pneumonitis, and not require corticosteroids. Evidence of fibrosis within a radiation field from prior radiotherapy is permitted with medical monitor approval. A 1-week washout period is permitted for palliative radiation to non-CNS disease with medical monitor approval.
    6. Known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
    7. Unless approved by the medical monitor, receipt of autologous hematopoietic stem cell transplant within 3 months before receiving the first dose of study drug(s), receipt of allogeneic stem cell transplant within 6 months before receiving the first dose of study drug(s), or active graft-versus-host disease after transplant, or receipt of immunosuppressive therapy following allogeneic transplant within 2 weeks of Cycle 1 Day 1 (prednisone ≤ 10 mg/day is allowed).
    8. Participants with laboratory values at screening, without transfusions and hematopoietic growth factor support, defined in Table 6 (transfusions are permitted to achieve required hemoglobin level that remains above ≥ 9 g/L for at least 2 weeks).
    10. History or evidence of bleeding disorder or active clinically significant bleeding requiring medical intervention.
    11. Has a significant concurrent, uncontrolled medical condition, including but not limited to the following:
    a. GI
    − Inability of the participant to swallow and retain oral medication.
    b. Cardiovascular
    − Clinically significant or uncontrolled cardiac disease, including unstable angina, acute myocardial infarction within 6 months from Day 1 of study drug administration, New York Heart Association Class III or IV congestive heart failure, and unstable arrhythmia requiring therapy unless approved by medical monitor/sponsor.
    − History or presence of an abnormal ECG, which, in the investigator's opinion, is clinically meaningful. A screening QTcF interval > 470 ms is excluded. For participants with an intraventricular conduction delay (QRS interval ≥ 120 ms), the JTc interval may be used in place of the QTc with sponsor approval. Participants with left bundle branch block are excluded.
    12. Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment, unless approved by medical monitor.
    15. Prior treatment with an LSD1 inhibitor for any indication.
    17. Current use of prohibited medication as described in Section 6.7.2.
    18. Inability or unlikeliness of the participant to comply with the dose schedule and study evaluations, in the opinion of the investigator.
    19. Inadequate recovery from toxicity and/or complications from a major surgery before starting therapy.

    Please refer to the protocol for the complete list of exlusion criteria.
    E.5 End points
    E.5.1Primary end point(s)
    Safety and tolerability as assessed by monitoring the frequency, severity, and duration of AEs through physical examinations, by evaluating changes in vital signs and ECGs, and through clinical and laboratory assessments.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Throughout the whole duration of the study.
    E.5.2Secondary end point(s)
    - ORR, defined as the percentage of participants who have a CR or PR as determined by investigator assessment of response in accordance with RECIST v1.1
    - PK parameters including Cmax, tmax, Cmin, AUC, t½, Cl/F.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Throughout the whole duration of the study.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response 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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Phase 1b
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA5
    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
    Italy
    Spain
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS (follow-up included)
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 13
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 13
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 6
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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 state2
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 21
    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 Decision2018-08-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-05-30
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2020-06-25
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