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    Summary
    EudraCT Number:2015-005317-68
    Sponsor's Protocol Code Number:ACE-CL-208
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-06-28
    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 number2015-005317-68
    A.3Full title of the trial
    A Phase 2 Study of the Efficacy and Safety of ACP-196 in Subjects with Relapsed/Refractory CLL and Intolerant of Ibrutinib Therapy
    Etude de phase 2 visant à évaluer l'efficacité et la sécurité d'emploi de l'ACP-196 chez des patients atteints de LLC en rechute/réfractaire et présentant une intolérance au traitement par ibrutinib
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2 Study of the Efficacy and Safety of ACP-196 in Subjects with Relapsed/Refractory CLL and Intolerant of Ibrutinib Therapy
    A.3.2Name or abbreviated title of the trial where available
    ACE-CL-208
    A.4.1Sponsor's protocol code numberACE-CL-208
    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 SponsorAcerta Pharma, BV
    B.1.3.4CountryNetherlands
    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 supportAcerta Pharma
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAcerta
    B.5.2Functional name of contact pointPriti Patel,Senior Medical Director
    B.5.3 Address:
    B.5.3.1Street Address2200 Bridge Parkway, Suite 202
    B.5.3.2Town/ cityRedwood City
    B.5.3.3Post codeCA 64065
    B.5.3.4CountryUnited States
    B.5.4Telephone number001650787 4817
    B.5.6E-mailp.patel@acerta-pharma.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 Yes
    D.2.5.1Orphan drug designation numberEMA/OD/196/15
    D.3 Description of the IMP
    D.3.2Product code ACP-196
    D.3.4Pharmaceutical form Capsule
    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 INNacalabrutinib
    D.3.9.1CAS number 1420477-60-6
    D.3.9.2Current sponsor codeACP-196
    D.3.9.3Other descriptive nameACP-196
    D.3.9.4EV Substance CodeSUB166233
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    High Risk Chronic Lymphocytic Leukemia
    Leucémie Lymphoïde Chronique à haut risque
    E.1.1.1Medical condition in easily understood language
    High Risk Chronic Lymphocytic Leukemia
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10008976
    E.1.2Term Chronic lymphocytic 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
    To check the efficacy of acalabrutinib in subjects with relapsed/refractory CLL who are intolerant of ibrutinib therapy
    Évaluer l'efficacité de l'acalabrutinib chez des patients atteints de LLC en rechute ou réfractaire présentant une intolérance au traitement par ibrutinib.
    E.2.2Secondary objectives of the trial
    To evaluate the safety and tolerability of acalabrutinib in subjects with relapsed/refractory CLL who are intolerant of ibrutinib therapy
    EXPLORATORY OBJECTIVES:
    - To determine the effect of acalabrutinib on peripheral blood B cells, T cells, NK cells, and MDSCs.
    - To evaluate potential predictive biomarkers and mechanisms of resistance for the disease.
    Évalue la sécurité et la tolérance de l'acalabrutinib chez des patients atteints de LLC en rechute ou réfractaire présentant une intolérance au traitement par ibrutinib.
    Objectifs exploratoires :
    - Déterminer l'effet de l'acalabrutinib sur les lymphocytes B, les lymphocytes T, les lymphocytes NK et les lymphocytes suppresseurs d'origine myéloïde (MDSC) du sang périphérique.
    - Évaluer les biomarqueurs prédictifs potentiels et les mécanismes de résistance de la maladie.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1-Prior diagnosis of CLL that meets published diagnostic criteria (Hallek 2008)
    2-Must have received ≥ 1 prior therapy for CLL and not be appropriate for treatment or retreatment with purine analogue-based therapy
    3-Intolerant of ibrutinib, defined as the subject has discontinued ibrutinib therapy due to Grade 3 or 4 AEs that persisted in spite of optimal supportive care measures OR patients who had Grade 2 AEs related to ibrutinib therapy, in spite of optimal supportive care measures, that persisted for ≥ 2 weeks or that recurred ≥ 2 times whether dose was reduced or discontinued.
    4-ECOG performance status of ≤ 2
    E.4Principal exclusion criteria
    1-Ongoing Grade 3 or 4 AE attributed to ibrutinib therapy. Note: Patients may be eligible for enrollment once the ibrutinib-related AE improves to Grade ≤ 2.
    2-Treatment with systemic anticancer therapy for CLL is prohibited between discontinuation of ibrutinib and enrollment on this trial.
    3-Prior exposure to a BCL-2 inhibitor (eg, ABT-199).
    4-Prior malignancy (other than CLL), except for adequately treated basal cell or squamous cell skin cancer, in situ cancer, or other cancer from which the subject has been disease free for ≥ 2 years.
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy will be evaluated based on the IWCLL 2008 criteria.
    The primary efficacy endpoint is Overall Response Rate (ORR) assessed by the investigators at the end of treatment.
    E.5.1.1Timepoint(s) of evaluation of this end point
    See section above.
    E.5.2Secondary end point(s)
    The secondary efficacy endpoints are:
    - Duration of Response (DOR)
    - Progression-Free Survival (PFS)
    - Time to Next Treatment (TTNT)
    - Overall Survival (OS)

    The safety of acalabrutinib will be characterized by laboratory assessments performed throughout the study and the type, frequency, severity, and attribution of AEs, or AEs leading to discontinuation of study treatment.

    The exploratory objectives will be evaluated through pharmacodynamic and biomarker parameters. The occupancy of Btk by acalabrutinib will be measured in PBMCs with the aid of a biotin-tagged acalabrutinib analogue probe. The effect of acalabrutinib on B cells, NK cells (CD56+), T cells (CD3+, CD4+, CD8+ levels), and MDSCs (HLA-DR- CD14+CD11b+ CD33+ levels) will also be evaluated. Genotyping for Btk, p53, and PLC? mutations will be performed.
    E.5.2.1Timepoint(s) of evaluation of this end point
    See section above.
    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 No
    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) 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 concerned6
    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
    Belgium
    France
    Israel
    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
    The end of trial is defined as the point when the last subject enrolled completes end of Cycle 36 or withdraws for any reason and completes the 30-day SFU visit (if applicable), whichever occurs first.
    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 months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months8
    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: 40
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 80
    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)
    After completing study regimen treatment can continue until the end of the trial for subjects without disease progression and who are tolerating therapy after discussion with the medical monitor.
    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 Decision2016-06-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-06-29
    P. End of Trial
    P.End of Trial StatusCompleted
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