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    Summary
    EudraCT Number:2014-002217-31
    Sponsor's Protocol Code Number:2215-CL-0101
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-09-15
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2014-002217-31
    A.3Full title of the trial
    A Phase 1/2 Open-Label, Dose Escalation Study Investigating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ASP2215 in Patients with Relapsed or Refractory Acute Myeloid Leukemia
    Studio di fase 1/2 in aperto, a dose crescente, per valutare la sicurezza, la tollerabilità, la farmacocinetica e la farmacodinamica di ASP2215 in pazienti con leucemia mieloide acuta recidiva o refrattaria
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Dose Escalation Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of ASP2215 in Patients with Relapsed or Refractory Acute Myeloid Leukemia
    Studio a dose crescente, per valutare la sicurezza, la tollerabilità, la farmacocinetica e la farmacodinamica di ASP2215 in pazienti con leucemia mieloide acuta recidiva o refrattaria
    A.4.1Sponsor's protocol code number2215-CL-0101
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02014558
    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 SponsorAstellas Pharma Global Development, 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 supportAstellas Pharma Global Development, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstellas Pharma Europe B.V.
    B.5.2Functional name of contact pointService Desk - Global Clinical Dev.
    B.5.3 Address:
    B.5.3.1Street AddressSlyviusweg 62
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333 BE
    B.5.3.4CountryNetherlands
    B.5.4Telephone number3171545 5050
    B.5.6E-mailcontact@nl.astellas.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 ASP2215
    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 INNNA
    D.3.9.3Other descriptive nameASP2215
    D.3.9.4EV Substance CodeSUB166897
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number10 to 100
    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 Acute Myeloid Leukemia
    E.1.1.1Medical condition in easily understood language
    Leukemia
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10000886
    E.1.2Term Acute myeloid leukemia
    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
    Assess the safety and tolerability, including determination of the maximum tolerated dose (MTD) of oral ASP2215 in subjects with relapsed or treatment-refractory AML.
    Determine the pharmacokinetic (PK) parameters of ASP2215.
    E.2.2Secondary objectives of the trial
    Investigate the anti-leukemic activity of various doses of ASP2215 in subjects with AML.
    Evaluate the effect of strong or moderate cytochrome P450-isozyme3A4 (CYP3A4) inhibitors on the PK of ASP2215.
    Evaluate the potential induction of CYP3A4 by ASP2215 by assessment of midazolam PK.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Pharmacogenetic sub-study.
    E.3Principal inclusion criteria
    1) Subject is ≥18 years of age at the time of obtaining informed consent.
    2) Subject is defined as morphologically documented primary or secondary AML by the World Health Organization (WHO) criteria (2008) and fulfills one of the followings:
    • Refractory to at least 1 cycle of induction chemotherapy
    • Relapsed after achieving remission with a prior therapy
    3) Subject has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
    4) Subject’s interval from prior treatment to time of study drug administration is at least 2 weeks for cytotoxic agents (except hydroxyurea given for controlling blast cells), or at least 5 half-lives for prior experimental agents or noncytotoxic agents, including immunosuppressive therapy post hematopoietic stem cell transplantation (HSCT).
    5) Subject must meet the following criteria as indicated on the clinical laboratory tests.
    • Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 x institutional upper limit normal (ULN)
    • Total serum bilirubin ≤1.5 x institutional ULN
    • Serum creatinine ≤1.5 x institutional ULN or an estimated glomerular filtration rate (eGFR) of > 50 ml/min as calculated by the Modification of Diet in Renal Disease (MDRD) equation.
    E.4Principal exclusion criteria
    1. Subject was diagnosed as acute promyelocytic leukemia (APL).
    2. Subject has BCR-ABL-positive leukemia (chronic myelogenous leukemia in blast crisis).
    3. Subject has active malignant tumors other than AML or Myelodysplastic Syndrome (MDS).
    4. Subject has persistent non-hematological toxicities of≥ Grade 2 (CTC AE v4), with symptoms and objective findings, from prior AML treatment (including chemotherapy, kinase inhibitors, immunotherapy, experimental agents, radiation, or surgery).
    5. Subject has had hematopoietic stem cell transplant (HSCT) and meets any of the following:
    • Is within 2 months of transplant from C1D1
    • Has clinically significant graft-versus-host disease requiring treatment
    • Has ≥ Grade 2 persistent non-hematological toxicity related to the transplant
    Donor lymphocytes infusion (DLI) is not permitted ≤ 30 days prior to study registration or during the first cycle of treatment on the study in Cohort 1 and first two cycles of the treatment in Cohort 2.
    6. Subject has clinically active central nervous system leukemia.
    7. Subject has disseminated intravascular coagulation abnormality (DIC).
    8. Subject has had major surgery within 4 weeks prior to the first study dose.
    9. Subject has had radiation therapy within 4 weeks prior to the first study dose.
    10. Subject has congestive heart failure NYHA class 3 or 4, or subject with a history of congestive
    heart failure NYHA class 3 or 4 in the past, unless a screening echocardiogram performed within
    3 months prior to study entry results in a left ventricular ejection fraction that is ≥ 45%.
    11. Subject requires treatment with concomitant drugs that are strong inhibitors or inducers of
    CYP3A4 with the exception of antibiotics, antifungals, and antivirals that are used as standard of
    care post-transplant or to prevent or treat infections and other such drugs that are considered
    absolutely essential for the care of the subject.
    12. Subject requires treatment with concomitant drugs that target serotonin 5HT1R or 5HT2BR
    receptors or sigma nonspecific receptor with the exception of drugs that are considered absolutely
    essential for the care of the subject.
    E.5 End points
    E.5.1Primary end point(s)
    Safety and Tolerability (Determine Maximum tolerated dose)
    Pharmacokinetics (ASP2215)
    E.5.1.1Timepoint(s) of evaluation of this end point
    (Unknown as dose escalation study)
    E.5.2Secondary end point(s)
    Efficacy of ASP2215 in AML
    • CR rate
    • Composite CR rate (CR + CRp + CRi)
    • Best response rate (CRc + partial remission (PR))
    • Duration of response
    • Overall survival
    • Event free survival
    • Leukemia free survival
    Pharmacokinetics of ASP2215, effect of strong or moderate CYP3A4 inhibitors
    Pharmacokinetics of midazolam, potential induction of CYP3A4 by ASP2215
    E.5.2.1Timepoint(s) of evaluation of this end point
    (Unknown as dose escalation 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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 Yes
    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 Yes
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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
    France
    Germany
    Italy
    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
    Last visit last subject.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months3
    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: 115
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 115
    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 No
    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 state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 230
    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. After the 30 day follow-up, patients will be followed up by phone every 3 months, for survival information.
    Nessuno. Dopo il follow-up di 30 giorni, i pazienti saranno seguiti per telefono ogni 3 mesi per informazioni sulla sopravvivenza.
    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 Decision2014-11-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-12-02
    P. End of Trial
    P.End of Trial StatusCompleted
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