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    Summary
    EudraCT Number:2012-004322-24
    Sponsor's Protocol Code Number:ARN-509-003
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-10-03
    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 ConcernedSlovakia - SIDC (Slovak)
    A.2EudraCT number2012-004322-24
    A.3Full title of the trial
    A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Study of ARN-509 in Men with Non-Metastatic (M0) Castration-Resistant Prostate Cancer
    Multicentrická, randomizovaná, dvojito zaslepená, placebom kontrolovaná štúdia ARN-509 fázy III u mužov s nemetastázujúcim (M0) kastračne rezistentným karcinómom prostaty
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Clinical study to assess the safety and effectiveness of ARN-509 in men with Castration-Resistant Prostate Cancer (prostate cancer not responsive to castration treatment)
    A.3.2Name or abbreviated title of the trial where available
    SPARTAN
    A.4.1Sponsor's protocol code numberARN-509-003
    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 SponsorAragon Pharmaceuticals, 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 supportAragon Pharmaceuticals Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAragon Pharmaceuticals, Inc
    B.5.2Functional name of contact pointVP, Clinical Development
    B.5.3 Address:
    B.5.3.1Street Address12780 El Camino Real, Suite 301
    B.5.3.2Town/ citySan Diego
    B.5.3.3Post codeCA 92130
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1858369 7627
    B.5.5Fax number+1858639 7662
    B.5.6E-mailecmaneval@aragonpharm.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 ARN-509
    D.3.4Pharmaceutical form Capsule, soft
    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 INNApalutamide
    D.3.9.1CAS number 956104-40-8
    D.3.9.3Other descriptive nameJNJ-56021927-AAA
    D.3.9.4EV Substance CodeSUB127215
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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.3.2Product code ARN-509
    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 INNApalutamide
    D.3.9.1CAS number 956104-40-8
    D.3.9.3Other descriptive nameJNJ-56102927-AAA
    D.3.9.4EV Substance CodeSUB127215
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, soft
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Castration-Resistant Prostate Cancer
    E.1.1.1Medical condition in easily understood language
    Prostate cancer with rapidly rising PSA not responsive to hormonal treatment.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10036909
    E.1.2Term Prostate cancer metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate superiority in the metastasis-free survival (MFS) of men with high risk NM-CRPC treated with Apalutamide versus placebo
    E.2.2Secondary objectives of the trial
    To compare the overall survival (OS) of men with high risk NM-CRPC treated with Apalutamide versus placebo and:
     To compare the time to symptomatic progression in men with high risk NM-CRPC treated with Apalutamide versus placebo
     To compare the time to initiation of cytotoxic chemotherapy in men with high risk NM-CRPC treated with Apalutamide versus placebo
     To compare the progression-free survival (PFS) of men with high risk NM-CRPC treated with Apalutamide versus placebo
     To compare the time to metastasis (TTM) in men with high risk NM-CRPC treated with Apalutamide versus placebo
     To evaluate the safety and tolerability of Apalutamide
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    VENTRICULAR REPOLARIZATION SUB-STUDY: (Appendix 8, Protocol Version 3.0 08 May 2013)
    To evaluate the effect of Apalutamide on ventricular repolarization in a subset of patients from selected clinical sites. The effect of Apalutamide on ventricular repolarization will be centrally analyzed by a third-party cardiac safety laboratory in a subset of 100 patients enrolled at selected sites that will be participating in the main protocol. Both Apalutamide and placebo patients will be enrolled in a blinded manner as per the main protocol randomization criteria.
    -The primary objective of this sub-study is to evaluate whether ARN-509 has a threshold pharmacological effect on cardiac repolarization, as detected by changes in electrocardiogram (ECG) QT intervals corrected for heart rate by Fridericia’s correction method (QTcF)
    -The secondary objectives of this study sub-study are as follows:
    -To investigate the effect of Apalutamide on the following ECG parameters: PR, RR, QRS, QT, QTcB (Bazett’s correction method), and T-Wave morphology
    -To further characterize the pharmacokinetic (PK) profile of Apalutamide and to assess the exposure-effect relationships (if any) between Apalutamide plasma concentrations and ECG interval change
    E.3Principal inclusion criteria
    1. Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features, with high risk for development of metastases, defined as PSADT ≤ 10 months. PSADT is calculated using at least 3 PSA values obtained during continuous ADT (see Section 5.1).
    2. Castration-resistant prostate cancer demonstrated during continuous ADT, defined as 3 PSA rises at least 1 week apart, with the last PSA > 2 ng/mL
    3. Surgically or medically castrated, with testosterone levels of <50 ng/dL. If the patient is medically castrated, continuous dosing with GnRHa must have been initiated at least 4 weeks prior to randomization and must be continued throughout the study to maintain castrate levels of testosterone.
    4.Patients receiving bone loss prevention treatment with bone-sparing agents indicated for the treatment of osteoporosis at doses and dosing schedule appropriate for the treatment of osteoporosis (e.g., denosumab [Prolia®], zoledronic acid [Reclast®]) must be on stable doses for at least 4 weeks prior to randomization.
    5. Patients who received a first generation anti-androgen (e.g., bicalutamide, flutamide, nilutamide) must have at least a 4-week washout prior to randomization AND must show continuing disease (PSA) progression (an increase in PSA) after washout.
    6. At least 4 weeks must have elapsed from the use of 5-α reductase inhibitors (e.g., dutasteride, finasteride), estrogens (irrespective of dose used), and any other anti-cancer therapy prior to randomization, including chemotherapy given in the adjuvant/neoadjuvant setting (e.g., clinical trial)
    7. At least 4 weeks must have elapsed from major surgery or radiation therapy prior to randomization
    8. Age ≥ 18 years
    9. Eastern Cooperative Oncology Group (ECOG) Performance Status grade 0 or 1
    10. Resolution of all acute toxic effects of prior therapy or surgical procedure to Grade 1 or baseline prior to randomization
    11. Adequate organ function as defined by the following criteria:
    -Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase [SGOT]) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase [SGPT]) ≤ 2.5 x upper limit of normal (ULN)
    -Total serum bilirubin ≤1.5 x ULN. Total serum bilirubin >1.5 x ULN is allowed if Gilbert’s disease is documented prior to end of screening procedures
    -Serum creatinine ≤ 2 x ULN
    -Absolute neutrophil count (ANC) ≥ 1500/μL
    -Platelets ≥ 100,000/μL
    -Hemoglobin ≥ 9.0 g/dL
    -Administration of growth factors or blood transfusions will not be allowed within 4 weeks of the hematology labs required to confirm eligibility
    12. Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to randomization
    13. Willingness and ability to comply with scheduled visits, treatment plans, laboratory and radiographic assessments, and other study procedures, including ability to swallow study drug tablets, the completion of patient reported outcomes questionnaires and long-term follow-up visits

    Eligibility Criteria for Placebo Subjects to Crossover to Open Label
    Apalutamide:
    1a. Subject is willing and able to provide written informed consent to
    crossover to open-label apalutamide
    2a. Subject has adequate organ function as defined by the following
    criteria:
    -Serum aspartate transaminase (AST; serum glutamic oxaloacetic
    transaminase [SGOT]) and serum alanine transaminase (ALT; serum
    glutamic pyruvic transaminase [SGPT]) ≤ 2.5 x upper limit of normal
    (ULN)
    -Total serum bilirubin ≤1.5 x ULN
    -Total serum bilirubin >1.5 x ULN is allowed if Gilbert's disease has been
    previously documented
    -Serum creatinine ≤ 2 x ULN
    -Absolute neutrophil count (ANC) ≥ 1500/L
    -Platelets ≥ 100,000/L
    -Hemoglobin ≥ 9.0 g/dL
    3a. Subject has not received any other systemic therapy for nonmetastastic
    castrate resistant prostate cancer other than blinded study
    drug and androgen deprivation therapy.
    4a. Subjects who have previously had an end of treatment visit and
    evidence of distant metastasis from the blinded independent central
    reviewer will not be eligible for open label apalutamide.
    5a. Subjects who had study treatment withheld for ≥28 consecutive days
    at the time of unblinding will need approval from the medical monitor to
    be eligible for crossover.
    E.4Principal exclusion criteria
    1.Presence of distant metastases confirmed by blinded independent central review (BICR), including CNS and vertebral or meningeal involvement, or history of distant metastases. Exception: Pelvic lymph nodes <2 cm in short axis (N1) located below the iliac bifurcation are allowed
    2. Symptomatic loco-regional disease requiring medical intervention, such as moderate or severe urinary obstruction or hydronephrosis due to primary tumor (e.g., tumor obstruction of bladder trigone)
    3. Prior treatment with second generation anti-androgens (e.g., enzalutamide)
    4. Prior treatment with CYP17 inhibitors (e.g., abiraterone acetate, orteronel, galerterone, ketoconazole, aminoglutethimide)
    5. Prior treatment with radiopharmaceutical agents (e.g., Strontium-89), immunotherapy (e.g., sipuleucel-T), or any other investigational agent for NM-CRPC
    6. Prior chemotherapy for prostate cancer except if administered in the adjuvant/neoadjuvant setting
    7. History of seizure or condition that may pre-dispose to seizure (e.g., stroke within 1 year prior to randomization, brain arteriovenous malformation, Schwannoma, meningioma, or other benign CNS or meningeal disease which may require treatment with surgery or radiation therapy)
    8. Concurrent therapy with any of the following (all must have been
    discontinued or substituted for at least 4 weeks prior to randomization):
     Medications known to lower the seizure threshold (for a complete list please see Appendix 5)
     Herbal (e.g. saw palmetto) and non-herbal (e.g. pomegranate) products that may decrease PSA levels
     Systemic (oral/IV/IM) corticosteroids. Short term use (≤ 4 weeks) of corticosteroids during the study is allowed if clinically indicated, but it should be tapered off as soon as possible
     Any other experimental treatment on another clinical trial
     Agents indicated for the prevention of skeletal-related events in patients with solid tumors (e.g., denosumab [Xgeva®])
    9. History or evidence of any of the following conditions:
     Any prior malignancy (other than adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or any other cancer in situ currently in complete remission) within 5 years prior to randomization
     Any of the following within 6 months prior to randomization: Severe/unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (e.g., pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias
     Uncontrolled hypertension (systolic blood pressure ≥160 mmHg or diastolic BP≥100 mmHg). Patients with a history of uncontrolled hypertension are allowed provided blood pressure is controlled by anti-hypertensive treatment.
     Gastrointestinal disorder affecting absorption
     Active infection, such as human immunodeficiency virus (HIV)
     Any other condition that, in the opinion of the Investigator, would impair the patient’s ability to comply with study procedures.
    E.5 End points
    E.5.1Primary end point(s)
    Metastasis-Free Survival (MFS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    MFS data for patients without metastasis or death will be censored on the date of the last tumor assessment (or, if no tumor assessment was performed after the baseline visit, at the date of randomization + 1 day).
    Tumor assessments will be performed at baseline and at 16-week intervals from randomization. Imaging studies will include a CT scan of the chest, abdomen, and pelvis, plus a bone scan.
    E.5.2Secondary end point(s)
    For the secondary endpoints, a hierarchical testing will be performed in
    the following order:
    -Time to Metastasis (TTM)
    -Progression-Free Survival (PFS)
    -Time to symptomatic progression
    -Overall Survival (OS)
    -Time to initiation of cytotoxic chemotherapy


    E.5.2.1Timepoint(s) of evaluation of this end point
    OS (every 4 months via clinic visit or telephone contact)
    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 Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA185
    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
    Australia
    Austria
    Belgium
    Canada
    Czech Republic
    Denmark
    Finland
    France
    Germany
    Hungary
    Israel
    Italy
    Korea, Republic of
    Netherlands
    New Zealand
    Norway
    Poland
    Russian Federation
    Spain
    Sweden
    Taiwan
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    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
    Patients will remain on study until BICR-confirmed disease progression, development of unacceptable toxicity, or withdrawal of consent.
    If the study is not terminated beforehand per the recommendation of the DMC, the end of trial in all participating countries will be defined as the time at which the secondary endpoint of OS has been met.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months5
    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: 360
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 840
    F.2 Gender
    F.2.1Female No
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 640
    F.4.2.2In the whole clinical trial 1200
    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)
    Patients will be followed for at least 28 calendar days after the last dose of study drug.All patients discontinuing study treatment will enter the survival follow-up period and will be followed for the development of symptomatic progression and initiation of subsequent anti-cancer therapies every 4 months until death, loss of follow-up, or withdrawal of consent, whichever comes first.CROSSOVER:Patients randomized to placebo will be offered open-label
    treatment with apalutamide after unbliding.
    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 Decision2014-11-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-10-14
    P. End of Trial
    P.End of Trial StatusOngoing
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