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    Summary
    EudraCT Number:2014-001051-23
    Sponsor's Protocol Code Number:ARRAY-520-215
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-07-07
    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 ConcernedGermany - BfArM
    A.2EudraCT number2014-001051-23
    A.3Full title of the trial
    A Multicenter Phase 2 Study of Single-agent Filanesib (ARRY-520) in Patients With Advanced Multiple Myeloma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    This study is designed to assess the efficacy and safety of filanesib in patients with multiple myeloma who have received at least 2 prior lines of therapy; have received prior bortezomib and lenalidomide; and have disease resistant to treatment with carfilzomib and/or pomalidomide.
    A.3.2Name or abbreviated title of the trial where available
    Filanesib (ARRY-520) in Patients With Advanced Multiple Myeloma
    A.4.1Sponsor's protocol code numberARRAY-520-215
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02092922
    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 SponsorArray BioPharma 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 supportArray BioPharma Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationArray BioPharma Inc.
    B.5.2Functional name of contact pointTeri Whisenand
    B.5.3 Address:
    B.5.3.1Street Address3200 Walnut Street
    B.5.3.2Town/ cityBoulder, Colorado
    B.5.3.3Post code80301
    B.5.3.4CountryUnited States
    B.5.4Telephone number0013033861384
    B.5.5Fax number0013033861252
    B.5.6E-mailregulatoryaffairs@arraybiopharma.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 nameFilanesib
    D.3.2Product code ARRY-520
    D.3.4Pharmaceutical form Powder for concentrate for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNfilanesib
    D.3.9.1CAS number 885060-09-3
    D.3.9.2Current sponsor codeARRY-520
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3.5
    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
    Multiple myeloma
    E.1.1.1Medical condition in easily understood language
    Multiple myeloma is a cancer of plasma cells, a type of white blood cell normally responsible for producing antibodies.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10028228
    E.1.2Term Multiple myeloma
    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
    Estimate the objective response rate (ORR) for patients with low Baseline alpha 1-acid glycoprotein (AAG)
    E.2.2Secondary objectives of the trial
    In patients with low Baseline AAG and in patients with high Baseline AAG:
    • Evaluate additional measures of efficacy
    • Assess the safety of filanesib treatment
    • Assess exposure to filanesib
    • Assess correlation between filanesib exposure and changes in QTc
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    To further study the influence of filanesib on the QT interval, a subset of approximately 25 patients at selected study centers will participate in a PK/QTc substudy featuring time-matched triplicate ECGs and collection of venous blood samples for measurement of filanesib plasma concentration.
    E.3Principal inclusion criteria
    Patients must meet all of the following criteria to be eligible for enrollment in the study.
    1. Provide a personally signed and dated informed consent document prior to initiation of any study-related procedures that are not considered standard of care.
    2. Male or female ≥ 18 years of age at time of informed consent.
    3. Patients with confirmed multiple myeloma whose treatment history must include all of the following:
    a. Received at least 2 prior lines of therapy (induction therapy and stem cell transplant ± maintenance are to be considered a single line of therapy).
    b. Received at least 2 cycles of a bortezomib-containing regimen and 2 cycles of a lenalidomide-containing regimen, unless intolerant to these agents (defined as requiring discontinuation due to toxicity).
    c. Disease refractory to a carfilzomib-containing regimen and/or a pomalidomide-containing regimen. Refractory is defined as either failure to achieve an MR or better while on therapy, or development of PD while on therapy or within 60 days from last dose of therapy.
    4. Measurable multiple myeloma disease, defined as meeting at least one of the following criteria within 14 days prior to enrollment:
    a. A monoclonal Ig (M-protein) concentration on serum protein electrophoresis (SPEP) of ≥ 1.0 g/dL.
    b. Measurable urinary light chain secretion by quantitative analysis using urine protein electrophoresis (UPEP) of ≥ 200 mg/24 hours.
    c. Involved serum free light chain (FLC) level ≥ 10 mg/dL, provided the serum FLC ratio is abnormal.
    5. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 within 14 days prior to enrollment.
    6. Adequate hematology laboratory values within 14 days prior to enrollment:
    a. Neutrophils ≥ 1.5 × 10^9/L without growth factor support (defined as no growth factor administration for at least 14 days prior to observation). If the bone marrow contains ≥ 50% plasma cells, a neutrophil count of ≥ 1.0 × 10^9/L is allowed.
    b. Platelets ≥ 50 × 109/L without transfusion support during the 3 days prior to the test.
    7. Adequate hepatic and renal function laboratory values within 14 days prior to enrollment:
    a. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × the upper limit of normal (ULN).
    b. Total bilirubin ≤ 1.5 mg/dL, unless attributed to a conjugation abnormality (e.g., Gilbert’s syndrome).
    c. Serum creatinine ≤ 2.5 mg/dL or a calculated (Cockcroft and Gault formula) or measured creatinine clearance of ≥ 30 mL/min.
    8. If patient is female and of childbearing potential, she must have a negative serum beta human chorionic gonadotropin (β-HCG) test within 14 days prior to enrollment and consent to ongoing pregnancy testing during the course of the study.

    9. Male patients must agree to use an effective method of contraception per institutional standard through 90 days after the last administration of filanesib and female patients of childbearing potential must agree to use an effective method of contraception per institutional standard through 30 days after the last administration of filanesib.
    10. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
    E.4Principal exclusion criteria
    Patients meeting any of the following criteria are ineligible for enrollment in the study.
    1. Prior treatment with filanesib (ARRY-520) or any other KSP inhibitor.
    2. Past or current plasma cell leukemia (> 2 × 10^9/L circulating plasma cells and plasma cells accounting for ≥ 20% by white blood cell [WBC] differential).
    3. Primary amyloidosis (amyloidosis associated with multiple myeloma is allowed).
    4. POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes).
    5. Autologous or allogeneic stem cell or bone marrow transplant within 3 months prior to enrollment.
    6. Concomitant malignancies or previous malignancies (other than multiple myeloma) with less than a 2-year disease-free interval at the time of enrollment. Patients with adequately resected basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast, or Stage 1 prostate cancer are eligible irrespective of the time of diagnosis.
    7. Use of an investigational agent that is not expected to be cleared by the time of enrollment or that has been demonstrated to have prolonged side effects. Patients must have recovered from all side effects to a Grade 0 or 1 (except alopecia and neuropathy).
    8. Monoclonal antibody treatment for multiple myeloma within 28 days prior to enrollment.
    9. Cytotoxic therapy within 21 days prior to enrollment.
    10. Proteasome inhibitor therapy within 14 days prior to enrollment.
    11. Immunomodulatory agent therapy within 7 days prior to enrollment.
    12. Radiotherapy within 21 days prior to enrollment. However, if the radiation portal covered ≤ 5% of the bone marrow reserve, the patient is eligible irrespective of the end date of radiotherapy.
    13. Corticosteroid doses > 10 mg/day of prednisone or equivalent within 14 days prior to enrollment.
    14. Contraindication to filgrastim or mannitol.
    15. Any major surgery where adequate wound healing has not occurred prior to enrollment.
    16. Medical, psychiatric or other conditions that may interfere with patient safety or compromise the patient's ability to understand the patient information, to give informed consent, to comply with the study protocol, or to complete the study.
    17. Any severe concurrent disease or condition (including severe graft-versus-host disease, requirement for dialysis, symptomatic congestive heart failure [New York Heart Association Class III or IV], unstable angina pectoris, cardiac arrhythmia) which, in the judgment of the Investigator, would make the patient inappropriate for study participation.
    18. Known human immunodeficiency virus (HIV) seropositivity.
    19. Active hepatitis B or hepatitis C infection.
    20. Acute active infection requiring treatment.
    21. Pregnant or breastfeeding women.
    E.5 End points
    E.5.1Primary end point(s)
    ORR in patients with low Baseline AAG
    E.5.1.1Timepoint(s) of evaluation of this end point
    Patients may continue receiving filanesib in 28-day cycles as long as no treatment discontinuation criteria are met. Disease evaluations will be conducted on Day 1 (+/-4 days) of each cycle.
    E.5.2Secondary end point(s)
    ORR in patients with high Baseline AAG
    E.5.2.1Timepoint(s) of evaluation of this end point
    Patients may continue receiving filanesib in 28-day cycles as long as no treatment discontinuation criteria are met. Disease evaluations will be conducted on Day 1 (+/-4 days) of each cycle.
    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) 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 EEA30
    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
    Canada
    France
    Germany
    Greece
    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 the study will be when all enrolled patients (N ~ 160) have been evaluated for response (central efficacy review).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    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
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 110
    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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 160
    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)
    Subjects will be provided with follow-up care after completing their participation in the study (LVLS) in accordance with current medical standards.
    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 Decision2014-09-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-10-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-09-12
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