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    Summary
    EudraCT Number:2016-003736-21
    Sponsor's Protocol Code Number:ACE-LY-110
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2018-03-12
    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 number2016-003736-21
    A.3Full title of the trial
    A Phase 1/2 Proof-of-Concept Study of the Combination of Acalabrutinib and Vistusertib in Subjects with Relapsed/Refractory B-cell Malignancies
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of the Combination of Acalabrutinib and Vistusertib in Subjects with Relapsed/Refractory B-cell Malignancies
    A.4.1Sponsor's protocol code numberACE-LY-110
    A.5.4Other Identifiers
    Name:IND NUMBERNumber:133812
    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 supportAstra Zeneca
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAcerta Pharma LLC
    B.5.2Functional name of contact pointMedical Director (Ahmed Hamdy)
    B.5.3 Address:
    B.5.3.1Street Address121 Oyster Point Boulevard
    B.5.3.2Town/ citySouth San Francisco, CA
    B.5.3.3Post code94080
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1831 421 1757
    B.5.6E-mailRegulatoryScience@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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAcalabrutinib
    D.3.2Product code ACP-196
    D.3.4Pharmaceutical form Capsule, hard
    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.3.9.4EV 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.IMP: 2
    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 nameAZD2014 Film-Coated Tablet 25mg
    D.3.2Product code AZD2014
    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 INNn/a
    D.3.9.1CAS number 1009298-59-2
    D.3.9.2Current sponsor codeAZD2014
    D.3.9.4EV Substance CodeSUB181149
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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.IMP: 3
    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 nameAZD2014 Film-Coated Tablet 35mg
    D.3.2Product code AZD2014
    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 INNn/a
    D.3.9.1CAS number 1009298-59-2
    D.3.9.2Current sponsor codeAZD2014
    D.3.9.4EV Substance CodeSUB181149
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number35
    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.IMP: 4
    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 nameAZD2014 Film-Coated Tablet 50mg
    D.3.2Product code AZD2014
    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 INNn/a
    D.3.9.1CAS number 1009298-59-2
    D.3.9.2Current sponsor codeAZD2014
    D.3.9.4EV Substance CodeSUB181149
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    Part 1: De novo Diffuse large B-cell lymphoma (DLBCL), Transformed DLBCL and Richter syndrome (RS).
    Part 2: De novo Germinal center B-cell (GCB) DLBCL and De novo non-GCB DLBCL
    E.1.1.1Medical condition in easily understood language
    B-cell lymphoma
    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 10012822
    E.1.2Term Diffuse large B-cell lymphoma refractory
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10058728
    E.1.2Term Richter's syndrome
    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
    Part 1 Primary Objective: To determine a dose and schedule for vistusertib in combination with acalabrutinib 100 mg bid for evaluation in Part 2
    Part 2 Primary Objectives: To evaluate the safety of acalabrutinib and vistusertib when coadministered
    E.2.2Secondary objectives of the trial
    -To evaluate the PK of acalabrutinib and vistusertib when coadministered
    -To evaluate the clinical activity of acalabrutinib and vistusertib, when coadministered, as measured by ORR, including CR rate, DOR, DRR, PFS and OS
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Diagnosis of relapsed/refractory DLBCL as documented by medical records and with histology based on criteria established by WHO:
    a. If a subject has de novo DLBCL, the diagnosis is confirmed by biopsy and is immunohistologically characterized as de novo non-GCB DLBCL or de novo GCB DLBCL. Note that PMBCL is excluded from this protocol. Tumor tissue must also be available for sending to the sponsor for central cell of origin testing.
    b. If the subjects has RS, the diagnosis is confirmed by biopsy and is immunohistologically characterized as
    transformation to DLBCL. Tumor tissue must also be available for sending to the sponsor for central pathology
    testing. This histology applies to Part 1 only.
    c. If the subjects has transformed DLBCL, the diagnosis is confirmed by biopsy and is immunohistologically
    characterized as transformation to DLBCL from indolent lymphoma (eg, follicular lymphoma). Tumor tissue must also be available for sending to the sponsor for central pathology testing. This histology applies to Part 1 only.
    2. Men and women ≥18 years of age.
    3. Prior treatment for lymphoid malignancy:
    a. If the subject has DLBCL, there is no curative option with conventional therapy and the prior treatment included ≥ 1 prior combination chemoimmunotherapy regimen (eg, anthracycline based therapy with rituximab such R-CHOP). Also subjects should have relapsed after ASCT or should be noncandidates for ASCT.
    b. If the subject has RS, the subject must have had ≥1 prior treatment with a combination chemoimmunotherapy regimen.
    4. Presence of radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined as the presence of a ≥1.5 cm lesion, as measured in the longest dimension by CT scan for all histologies).
    5. Documented active disease that is relapsed or refractory defined as:
    a. Relapse: disease progression after completion of the treatment regimen preceding entry into the study.
    b. Refractory: progressive disease or stable disease as best response at any point during chemotherapy (>4 cycles of first-line or 2 cycles of later-line therapy) or relapsed at ≤12 months from autologous stem cell
    transplantation (Crump et al 2017).
    6. ECOG performance status of ≤2.
    7. Adequate hematologic function, independent of transfusion and growth factor support for ≥14 days before
    screening, defined as:
    a. ANC >1000 cells/mm3 (1.0 x 109/L)
    b. Platelet count >75,000 cells/mm3 (75 x 109/L) or >50,000 cells/mm3 with bone marrow involvement
    c. Hemoglobin >8.0 g/dL
    8. Adequate hepatic and renal function at screening defined as:
    a. Serum AST and ALT ≤2.5 x ULN if no demonstrable liver involvement or ≤3 x ULN in the presence of liver
    metastases
    b. Bilirubin ≤1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin)
    c. Serum creatinine ≤1.5 times ULN and creatinine clearance >30 mL/min (measured or calculated by Cockcroft and Gault equation [(140-Age) • Mass (kg)/(72 • creatinine mg/dL) • multiply by 0.85 if female])
    9. PT/INR <1.5 x ULN and aPTT <1.5 x ULN.
    10. Serum potassium within normal range.
    11. Women should be using adequate contraceptive measures, should not be breast feeding and must have a
    negative pregnancy test before start of dosing if of child-bearing potential or must have evidence of nonchildbearing potential by fulfilling one of the following criteria at screening:
    a. Post-menopausal defined as aged more than 50 years and amenorrhoeic for at least 12 months following
    cessation of all exogenous hormonal treatments
    b. Documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral
    salpingectomy but not tubal ligation
    12. Men should be willing to use barrier contraception (ie, condoms) and refrain from sperm donation during and after the conduct of the trial. If not done previously, storage of sperm before receiving vistusertib will be advised to male subjects with a desire to have children.
    13. Willing and able to participate in all required evaluations and procedures in this study protocol including
    swallowing capsules without difficulty.
    14. Willing to follow sunlight protection measures while taking vistusertib (eg, using sunscreen and avoiding
    excessive sun exposure) and for 90 days after the last dose of vistusertib.
    15. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local patient privacy regulations).
    E.4Principal exclusion criteria
    1. History of prior malignancy except for the following:
    a) Malignancy treated with curative intent and with no evidence of active disease present for more than 2 years before screening and felt to be at low risk for recurrence by treating physician.
    b) Adequately treated lentigo maligna melanoma without current evidence of disease or adequately controlled nonmelanomatous skin cancer.
    c) Adequately treated carcinoma in situ without current evidence of disease.
    2. As judged by the Investigator, any evidence of severe or uncontrolled systemic disease, or current unstable or uncompensated respiratory or cardiac conditions, or uncontrolled hypertension, history of, or active, bleeding diatheses or uncontrolled active systemic fungal, bacterial, viral, or other infection, or intravenous anti-infective treatment within 2 weeks before first dose of study drug.
    3. Diagnosis of PMBCL.
    4. Known history of infection with HIV.
    5. Serologic status reflecting active hepatitis B or C infection.
    6. Active CMV infection
    7. Undergone any of the following procedures or experienced any of the following conditions currently or in the preceding 6 months:
    a) coronary artery bypass graft
    b) angioplasty
    c) vascular stent
    d) myocardial infarction
    e) angina pectoris
    f) congestive heart failure (NYHA Grade ≥2)
    g) ventricular arrhythmias requiring continuous therapy
    h) supraventricular arrhythmias, including atrial fibrillation, which are uncontrolled
    i) hemorrhagic or thrombotic stroke, including transient ischemic attacks or any other central nervous system
    bleeding.
    8. Current refractory nausea and vomiting, malabsorption syndrome, disease significantly affecting GI function, resection of the stomach, extensive small bowel resection that is likely to affect absorption, symptomatic inflammatory bowel disease, partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass.
    9. History of CNS lymphoma, leptomeningeal disease or spinal cord compression.
    10. History of severe allergic or anaphylactic reactions to kinase inhibitors or history of hypersensitivity to active or inactive excipients of vistusertib or acalabrutinib or drugs with a similar chemical structure or class to vistusertib or acalabrutinib.
    11. Presence of a GI ulcer diagnosed by endoscopy within 3 months before screening.
    12. Uncontrolled Type 1 or Type 2 diabetes mellitus.
    13. Any clinically significant pre-existing renal disease or high risk of developing renal impairment.
    14. Major surgical procedure within 28 days before first dose of study drug. .
    15. Unresolved toxicities from prior anticancer therapy, defined as having not resolved to CTCAE, Version 4.03 Grade 0 or 1, or to the levels dictated in the inclusion/exclusion criteria, with the exception of alopecia.
    16. Any hematopoietic growth factors within 7 days of the first dose of study drug or pegylated G-CSF (pegfilgrastim) or darbepoetin within 14 days of the first dose of study drug.
    17. Vaccinated with live, attenuated vaccines within 4 weeks of first dose of study drug.
    18. Abnormal ECHO or MUGA at baseline (LVEF <40% and shortening fraction SF <15%).
    19. Mean resting QTc calculated using Fridericia's formula (QTcF) >450 msec obtained from 3 ECGs; family or
    personal history of long or short QT syndrome; Brugada syndrome or known history of QTc prolongation or Torsade de Pointes within 12 months of the subject entering the study.
    20. Factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, or family history of sudden unexplained death under 40 years of age. Concomitant medications known to prolong QTc should be used with caution and cannot be used during the first 28 days on study.
    21. Any therapeutic antibody within 4 weeks of first dose of study drugs.
    22.Prior use of standard antilymphoma therapy or radiation therapy within 14 days of receiving the first dose of study drug
    23. Ongoing immunosuppressive therapy, including systemic corticosteroids for treatment of lymphoid cancer or other conditions.
    24. Exposure to strong or moderate inhibitors or inducers of CYP3A4/5, P-gp, or BCRP, if taken within the stated washout periods before the first dose of study drug.
    26. Requires or receiving therapeutic anticoagulants, with the exception of short-acting heparins, within 7 days of first dose of study drug.
    27. Requires treatment with proton-pump inhibitors (eg, omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole).
    28. Concurrent participation in another therapeutic clinical trial
    E.5 End points
    E.5.1Primary end point(s)
    - Safety
    Verbatim descriptions of AEs will be mapped according to the MedDRA thesaurus terms and graded according to NCI CTCAE, v4.03 or higher.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Extent of exposure to study drug(s), all AEs, SAEs, any adverse events leading to study drug(s) discontinuation, and study drug(s) related-adverse events will be summarized. The frequency of AEs will be summarized by system organ class and preferred terms according to MedDRA, as well as per severity per NCI CTCAE grade. Treatment-emergent AEs will be summarized, unless otherwise specified. For events with varying severity, the worst reported grade will be used.
    Laboratory abnormalities will be defined based on laboratory normal ranges (universal normal ranges, if central lab). Selected laboratory parameters may be analyzed with shift tables and summaries of changes from baseline to worst post-treatment value.
    Vital sign assessments will be tabulated and summarized.
    E.5.2Secondary end point(s)
    - Analysis of Efficacy Parameters
    - Overall Response Rate (ORR) and Complete Response (CR)Rate
    - Progression-free Survival (PFS)
    - Duration of Response (DOR)
    - Durable Response Rate (DRR)
    - Overall Survival (OS)
    E.5.2.1Timepoint(s) of evaluation of this end point
    -The ORR is defined as the rate of subjects who achieve either a PR or CR, according to the revised response criteria for malignant lymphoma, as assessed by investigators before receiving any other anticancer therapy.
    - PFS is defined as the time from first dose date to documented disease progression, or death from any cause, whichever occurs first.
    -DOR is defined as the time from the first objective response of CR or PR to the time of documented disease
    progression or death due to any cause, whichever occurs first.
    -OS is defined as the time from first dose until the date of death from any cause.
    -The DRR is defined as the percentage of subjects who have a complete or partial response lasting ≥8 weeks.
    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 No
    E.6.10Pharmacogenetic Yes
    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 I/IIa
    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 Yes
    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 Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    This is a controlled trial with no randomization in Part 2, and randomization in Part 1
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    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 concerned7
    E.8.5The trial involves multiple Member States No
    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
    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 study for this protocol is when the last subject on the study has either discontinued the study or been transitioned to a roll over protocol.
    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 months3
    E.8.9.1In the Member State concerned days7
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days7
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 41
    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 state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 36
    F.4.2.2In the whole clinical trial 71
    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)
    If subjects have received 12 cycles of treatment (ie, been on study for about 12 months) and the study doctor feels they are tolerating the study drug(s) and their disease is not getting worse from taking acalabrutinib alone or taking together with vistusertib, subjects may be eligible to enroll into another study where they can continue to receive acalabrutinib alone or together with vistusertib. A separate consent will be provided for this new study.
    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 Decision2017-06-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-05-12
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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