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    The EU Clinical Trials Register currently displays   43841   clinical trials with a EudraCT protocol, of which   7281   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2013-003022-92
    Sponsor's Protocol Code Number:9785-CL-0403
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-12-05
    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 ConcernedSweden - MPA
    A.2EudraCT number2013-003022-92
    A.3Full title of the trial
    A Multicenter, Single-Arm, Open-Label, Post-Marketing Safety Study to Evaluate the Risk of Seizure Among Subjects with Metastatic Castration-Resistant Prostate Cancer (mCRPC) Treated with Enzalutamide Who Are at Potential Increased Risk of Seizure (UPWARD)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the risk of seizures among metastatic Castration-Resistant Prostate Cancer (mCRPC) patients treated with enzalutamide
    A.4.1Sponsor's protocol code number9785-CL-0403
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01977651
    A.5.4Other Identifiers
    Name:INDNumber:74,563
    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 AddressSylviusweg 62
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333 BE
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031715455050
    B.5.5Fax number0031715455501
    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 Yes
    D.2.1.1.1Trade name Xtandi
    D.2.1.1.2Name of the Marketing Authorisation holderAstellas Pharma Europe B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical 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 INNENZALUTAMIDE
    D.3.9.1CAS number 915087-33-1
    D.3.9.2Current sponsor codeMDV3100
    D.3.9.3Other descriptive nameEnzalutamide
    D.3.9.4EV Substance CodeSUB77412
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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
    Medical condition: metastatic castration-resistant prostate cancer (mCRPC)
    E.1.1.1Medical condition in easily understood language
    Medical condition: cancer of the prostate (a gland of the male reproductive system) which is metastatic (has spread to other parts of the body) and failed surgery and other treatment
    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 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
    The study objective is to evaluate the seizure rate and monitor the safety of enzalutamide treatment in subjects with metastatic castration-resistant prostate cancer known to have risk factor(s) for seizure.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Institutional Review Board (IRB)-/Independent Ethics Committee (IEC)-approved written Informed Consent and privacy language as per national regulations (e.g., Health Insurance Portability Accountability Act (HIPAA) authorization for United States sites) must be obtained from the subject or legally authorized representative prior to any study-related procedures (including withdrawal of prohibited medication, if applicable).
    2. Subject has histologically confirmed metastatic adenocarcinoma of the prostate.
    3. Subject has ongoing androgen deprivation therapy with a GnRH analogue (agonist or antagonist) or bilateral orchiectomy (i.e., surgical or medical castration).
    4. Subject has disease progression by at least 1 of the following:
    a) PSA progression defined by a minimum of 2 rising PSA levels with an interval of at least 1 week between each draw;
    b) Bone disease progression as defined by Prostate Cancer Working Group 2 guidelines (at least 2 new lesions) on bone scan; or
    c) Soft tissue disease progression as defined by RECIST 1.1
    5. For subjects who have not had an orchiectomy, there must be a plan to maintain effective GnRH-analogue therapy for the duration of the study.
    6. Subject must have failed at least one course of androgen deprivation therapy (ADT), i.e., treatment with GnRH analogues.
    7. Subject has an ECOG performance status of 0-2.
    8. Subject has been evaluated by a local neurologist prior to study entry who has determined the subject has at least one risk factor for seizure including:
    a) past history of seizure due to any cause except a single febrile seizure in childhood. Patients with a history of seizures should not have had a seizure within 12 months of Screening and must have had no anticonvulsants for 12 months prior to Screening.
    b) history of cerebrovascular accident (CVA) or transient ischemic attack (TIA),
    c) history of traumatic brain or head injury with loss of consciousness,
    d) unexplained loss of consciousness within the last 12 months,
    e) presence of a space occupying lesion in the brain including previously treated brain metastasis(es) or primary CNS tumor,
    f) history of arteriovenous malformations of the brain,
    g) history of brain infection (i.e., abscess, meningitis, or encephalitis),
    h) current use of medication that may lower seizure threshold (see Appendix 12.1),
    i) presence of Alzheimer’s disease, meningioma, leptomeningeal disease from prostate cancer.
    9. Male subject and his female partner who is of childbearing potential must use two acceptable methods of birth control (one of which must include a condom as a barrier method of contraception) starting at Screening and continuing throughout the study period and for 3 months after final study drug administration.
    a) Two acceptable forms of birth control include:
    i. Condom (barrier method of contraception), AND
    ii. One of the following acceptable forms of contraception is required:
    1. Established use of oral, injected or implanted hormonal methods of contraception.
    2. Placement of an intrauterine device (IUD) or intrauterine system (IUS).
    3. Barrier methods of contraception: Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository).
    4. Vasectomy or surgical castration at least 6 months prior to Screening.
    10. Male subject must use a condom, if having sex with a pregnant woman.
    11. Male subject must not donate sperm starting at Screening and throughout the study period and for at least 3 months after final drug administration.
    12. Subject is able to swallow the study drug and comply with study requirements.
    13. Subject agrees not to participate in another interventional study while on treatment.
    Waivers to the inclusion criteria will NOT be allowed.
    E.4Principal exclusion criteria
    Subject will be excluded from participation if any of the following apply:
    1. Subject with a history of exposure to enzalutamide.
    2. Subject has severe concurrent disease, infection, or co-morbidity that, in the judgment of the Investigator, would make the subject inappropriate for enrollment.
    3. Subject is currently treated with anti-epileptics.
    4. Subject has a history of seizure in the past 12 months of Screening as assessed by neurology examination and history.
    5. Subject with rapidly progressive visceral disease who has not received and is thought able to tolerate cytotoxic chemotherapy. (However, subject who has previously received cytotoxic chemotherapy is permitted).
    6. Subject has clinical signs suggestive of high or imminent risks for pathological fracture, spinal cord compression and/or cauda equina syndrome.
    7. Subject’s absolute neutrophil count is < 1500 /µL, platelet count is < 100,000/µL, or hemoglobin is < 5.6 mmol/L (9 g/dL) at Screening.
    8. Subject’s total bilirubin is ≥ 1.5 x ULN (except for subjects with documented Gilbert’s disease) or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) is
    ≥ 2.5x ULN at Screening.
    9. Subject’s estimated creatinine clearance (Cer) is less than 30 mL/min by the Cockcroft and Gault formula (Creatinine Clearance (mL/min) = (140 – age)(wt kg) / 72 x serum creatinine (mg/100 ml) [Cockcroft, 1976] at Screening.
    10. Subject has uncontrolled hypertension as indicated by a resting systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg at Screening.
    11. Subject has received an investigational agent within 4 weeks or 5 half lives whichever is longer prior to Day 1.
    12. Subject has shown a hypersensitivity reaction to the active pharmaceutical ingredient or any of the capsule components, including Labrasol, butylated hydroxyanisole, and butylated hydroxytoluene.
    13. Subject has any condition which, in the Investigator’s opinion, makes the subject unsuitable for study participation.
    Waivers to the exclusion criteria will NOT be allowed.
    E.5 End points
    E.5.1Primary end point(s)
    The proportion of evaluable subjects with at least one confirmed seizure as adjudicated by the Independent Adjudication Committee (IAC) during the 4-month treatment duration.
    An evaluable subject is defined as a subject with a confirmed seizure during the 4-month treatment period of the study or who completed at least 3 months (75%) of the planned treatment. Only an enrolled subject who discontinues the study before completing 3 months on treatment may be replaced at the discretion of the Sponsor, however, an enrolled subject who is discontinued due to a confirmed seizure event will not be replaced.
    A cumulative summary to include all seizure events, including those occurring beyond the 4 month treatment period will be included. In case the drop-out rate is higher than expected, appropriate method such as Kaplan-Meier estimations may be considered.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The proportion of evaluable subjects with at least one confirmed seizure as adjudicated by the Independent Adjudication Committee (IAC) during the 4 month duration.
    E.5.2Secondary end point(s)
    Not applicable.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable.
    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 No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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.8.2.4Number of treatment arms in the trial1
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA43
    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
    Argentina
    Australia
    Belgium
    Brazil
    Canada
    Chile
    Czech Republic
    Finland
    France
    Germany
    Greece
    Hong Kong
    Hungary
    Israel
    Italy
    Korea, Republic of
    New Zealand
    Singapore
    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
    The end of trial in all participating countries is defined as the Last Subject’s Last Visit.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months6
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 200
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 172
    F.4.2.2In the whole clinical trial 400
    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)
    Plans for treatment or care after for the subject is per the treating physician's discretion and what is best for the subject.
    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 Decision2014-04-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-04-29
    P. End of Trial
    P.End of Trial StatusCompleted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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