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    Summary
    EudraCT Number:2014-004989-23
    Sponsor's Protocol Code Number:G200901
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-05-28
    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 ConcernedUK - MHRA
    A.2EudraCT number2014-004989-23
    A.3Full title of the trial
    A Phase 2 Open Label, Multi-Center, Multinational Study Investigating The Efficacy and Safety Of GTx-024 On Advanced, Androgen Receptor-Positive Triple Negative Breast Cancer (AR+ TNBC)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study Assessing The Efficacy And Safety Of GTx-024 In Patients With Triple Negative Breast Cancer
    A.3.2Name or abbreviated title of the trial where available
    N/A
    A.4.1Sponsor's protocol code numberG200901
    A.5.4Other Identifiers
    Name:INDNumber:125281
    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 SponsorGTx, 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 supportGTx, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGTx, Inc.
    B.5.2Functional name of contact pointMayzie Johnston , Vice President
    B.5.3 Address:
    B.5.3.1Street Address175 Toyota Plaza, 7th Floor
    B.5.3.2Town/ cityMemphis
    B.5.3.3Post codeTN 38103
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1901261-3858
    B.5.5Fax number+1901271-8679
    B.5.6E-mailmjohnston@gtxinc.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 nameenobosarm
    D.3.2Product code GTx-024
    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 INNenobosarm
    D.3.9.2Current sponsor codeGTx-024
    D.3.9.3Other descriptive nameostarine
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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.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
    Androgen Receptor-Positive Triple Negative Breast Cancer (AR+ TNBC)
    E.1.1.1Medical condition in easily understood language
    breast cancer
    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 10057654
    E.1.2Term Breast cancer female
    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 19.0
    E.1.2Level LLT
    E.1.2Classification code 10072737
    E.1.2Term Advanced breast cancer
    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 19.0
    E.1.2Level LLT
    E.1.2Classification code 10027475
    E.1.2Term Metastatic breast cancer
    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 19.0
    E.1.2Level PT
    E.1.2Classification code 10055113
    E.1.2Term Breast cancer metastatic
    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 19.0
    E.1.2Level PT
    E.1.2Classification code 10006198
    E.1.2Term Breast cancer recurrent
    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 19.0
    E.1.2Level PT
    E.1.2Classification code 10006187
    E.1.2Term Breast cancer
    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 primary efficacy objective of this trial is to estimate the CBR at 16 weeks (defined as CR, PR, or SD) (by RECIST 1.1) of GTx-024 18 mg given PO daily in subjects with TNBC and centrally confirmed AR+ status.

    Safety objective:
    To describe the safety profile of GTx-024 18 mg PO daily in subjects with TNBC and centrally confirmed AR+ as well as in all subjects enrolled and treated.

    Pharmacokinetic objective:
    To describe the plasma concentrations of GTx-024 and GTx 024 glucuronide at each of the assessed time points.
    E.2.2Secondary objectives of the trial
    • Estimate the CBR at 16 weeks (by RECIST 1.1) of GTx 024 18 mg in all subjects enrolled who receive at least one dose of study medication regardless of AR status as determined by the central laboratory
    The following secondary efficacy objectives apply to both centrally confirmed AR+ subjects (the evaluable subset of the FAS) as well as to all subjects in the FAS:
    • Estimate the objective response rate (ORR; defined as CR or PR) (by RECIST 1.1) of GTx-024 18 mg at 16 weeks
    • Estimate the CBR (by RECIST 1.1) of GTx-024 18 mg at 24 weeks
    • Estimate the ORR (CR or PR) (by RECIST 1.1) of GTx-024 18 mg at 24 weeks
    • Estimate the best overall response rate of GTx 024 18 mg
    • Estimate the progression free survival of subjects receiving GTx-024 18 mg
    • Estimate the time-to-progression of subjects receiving GTx-024 18 mg
    • Estimate duration of response (from documentation of response to disease progression or death) of subjects receiving GTx-024 18 mg
    • Estimate overall survival (OS)
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Optional: Left over biospecimens (for example, blood and tissue samples) after analyses may be stored for future research uses from subjects who have consented and provided it is not prohibited by local laws and Ethics Committees. No additional samples will be collected except for those listed above. The samples will be stored for up to 10 years and destroyed after that. The samples may undergo genetic tests, tests for biomarkers, and other tests specific for the indication. It is the responsibility of the Investigator, or a person designated by the Investigator (if acceptable under local regulations), to obtain written informed consent from each individual who has consented to have their biospecimens stored for future research. Subjects must receive an explanation that they are completely free to refuse long-term storage of their samples for future research and may withdraw their sample at any time and for any reason during the 10 year storage period of the specimen(s), unless their sample has been retained in a anonymized manner (in which case it can no longer be identified as relating to the subject).
    E.3Principal inclusion criteria
    Adult women with advanced TNBC with centrally confirmed AR+.

    Subject Inclusion Criteria: Subjects eligible for inclusion in this study

    must meet all of the following criteria:
    1. Able and willing to give voluntary, written and signed, informed consent;

    2. Women ≥ 18 years of age;

    3. Women with TNBC who have received at least one but no more than two prior chemotherapy regimens for the treatment of advanced or metastatic TNBC;

    4. Confirmation of AR+ (defined as ≥ 10% nuclear AR staining by immunohistochemistry [IHC]) TNBC in either the primary or metastatic lesion, assessed prior to the start of or during the screening period by a local laboratory or by medical history;

    5. TNBC confirmed by medical history as: human epidermal growth factor receptor 2 [HER2]-negative (confirmed by IHC 0, 1+ regardless of
    fluorescence in situ hybridization [FISH] ratio; IHC 2+ with FISH ratio lower than 2.0 or HER2 gene copy less than 6.0; FISH ratio of 0, indicating gene deletion, when positive and negative in situ hybridization [ISH] controls are present); estrogen receptor (ER) negative (confirmed as ER expression less than or equal to 1% positive tumor nuclei);
    progesterone receptor negative (confirmed as progesterone receptor expression less than or equal to 1% positive tumor nuclei);

    6. Availability of paraffin embedded or formalin fixed tumor tissue; OR, a minimum of 10 and up to 20 slides of archived tumor tissue or new biopsy, if archived tissue is unavailable, for central laboratory confirmation of AR status and molecular subtyping. Metastatic tumor tissue is preferred when possible;

    7. Subjects must have either measurable disease or bone only nonmeasurable disease according to RECIST 1.1;

    8. Subjects with bone metastases should be treated with intravenous
    bisphosphonates or subcutaneous denosumab (or investigator preferred standard of care) prior to and/or during the trial, unless there is a contraindication or subject intolerance to these therapies. For subjects who are normocalcemic, therapy can be initiated at the time the subject initiates study drug;

    9. Eastern Cooperative Oncology Group (ECOG) performance status 3 0 or 1 at the time of screening and enrollment;

    10. Negative serum pregnancy test in women of childbearing potential (premenopausal or less than 12 months of amenorrhea post-menopause, and who have not undergone surgical sterilization), no more than 7 days before the first dose of study treatment;

    11. For women of childbearing potential who are sexually active, agreement to use a highly effective, non hormonal form of contraception during and for at least 6 months after completion of study treatment;
    OR, a fertile male partner willing and able to use effective non-hormonal means of contraception (barrier method of contraception in conjunction with spermicidal jelly, or surgical sterilization) during and for at least 6 months after completion of study treatment;

    12. Adequate organ function as shown by:
    ● Absolute neutrophil count ≥ 1,500 cells/mm3
    ● Platelet count ≥ 100,000 cells/mm3
    ● Hemoglobin ≥ 9 g/dL
    ● Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 Upper Limit of the Normal range (ULN) (or ≤ 5 if hepatic metastases are present)
    ● Total serum bilirubin ≤ 2.0 × ULN (unless the subject has documented Gilbert Syndrome)
    ● Alkaline phosphatase levels ≤ 2.5 × ULN (≤ 5 × ULN in subjects with liver metastasis)
    ● Serum creatinine ≤ 2.0 mg/dL or 177 μmol/L
    ● International normalized ratio (INR) or activated partial thromboplastin time (aPTT) < 1.5 × ULN (unless on anticoagulant treatment at screening);
    13. Able to swallow capsules;
    14. Any toxicity from prior chemotherapy has resolved or is Grade 1
    (NCI-CTCAE, Version 4.0).
    E.4Principal exclusion criteria
    Subjects eligible for this study must not meet any of the following criteria:

    1.Life expectancy < 4 months;
    2.Subjects with radiographic evidence of central nervous system (CNS) metastases as assessed by computerized tomography (CT) or magnetic resonance imaging (MRI) that are not well controlled (symptomatic or requiring control with continuous corticosteroid therapy [e.g., dexamethasone]). Note: Subjects with CNS metastases are permitted to participate in the study if the CNS metastases are medically well controlled prior to screening (as assessed by the Investigator) after receiving local therapy (irradiation, surgery, etc.);
    3.Radiotherapy within 14 days prior to first dose of study treatment;
    4.Have, in the judgment of the Investigator, a clinically significant concurrent illness or psychological, familial, sociological, geographical, or other concomitant condition that would not permit adequate follow-up and compliance with the study protocol;
    5.Positive hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infection at screening;
    6.Positive human immunodeficiency virus (HIV) infection at screening;
    7.Prior treatment with any anti-androgens, including but not limited to, enzalutamide and bicalutamide;
    8.Major surgery within 28 days of the first dose of study treatment;
    9.Be currently taking or have previously taken testosterone, methyltestosterone, oxandrolone (Oxandrin®), oxymetholone, danazol, fluoxymesterone (Halotestin®), testosterone-like agents (such as dehydroepiandrosterone, androstenedione, and other androgenic compounds, including herbals), or anti androgens;
    10.Treatment with any of the following hormone replacement therapies, unless discontinued at least 28 days prior to the first dose of study treatment:
    ●Estrogens
    ●Megesterol acetate;
    11.Treatment with any investigational agent within 28 days before the first dose of study treatment;
    12.Another active cancer (excluding adequately treated basal cell
    carcinoma or cervical intraepithelial neoplasia [CIN]/cervical carcinoma in situ or melanoma in situ). Prior history of other cancer is allowed as long as there is no active disease within the prior 5 years;
    13.Subject has a concomitant medical condition that precludes adequate study treatment compliance or assessment, or increases subject risk, in the opinion of the Investigator, such as but not limited to:
    ●Myocardial infarction or arterial thromboembolic events within 6 months prior to baseline or severe or unstable angina, New York Heart Association (NYHA) Class III or IV disease, or a QTc interval > 470 msec; serious uncontrolled cardiac arrhythmia grade II or higher according to NYHA; uncontrolled hypertension (systolic > 150 and/or diastolic > 100 mm Hg)
    ●Acute and chronic active infectious disorders and non-malignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this study therapy
    ●Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of study drugs (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome);
    14. Current treatment with intravenous bisphosphonate or denosumab with elevated serum calcium corrected for albumin or ionized calcium levels outside institutional normal limits at screening;
    15.History of non-compliance to medical regimens;
    16.Subjects unwilling to or unable to comply with the protocol procedures as assessed by the Investigator;
    17.Concurrent participation in another therapeutic clinical trial
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy endpoint: Tumor response in terms of clinical benefit will be assessed by RECIST 1.1 criteria from centrally read CT scans obtained at the 16 week assessment. Tumor response is judged relative to baseline tumor assessments. An evaluable subject will be considered to have a response of CB if the assessment indicates SD, PR, or CR. The
    primary assessment is among the evaluable subjects in the FAS at 16 weeks. An evaluable subject who does not have a week 16 assessment
    for any reason remains in the evaluable subset of the FAS and is considered a failure to achieve CB (SD, PR, or CR).
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 16
    E.5.2Secondary end point(s)
    • CBR in the FAS at 16 weeks.
    The following secondary efficacy endpoints will be assessed among evaluable subjects (if not already listed above), the FAS (if not already
    listed above), and the PPS:
    • CBR at weeks 16 and 24
    • ORR (PR or CR assessed by RECIST 1.1 criteria) at weeks 16 and 24.
    • Best (confirmed) overall response rate (BOR). BOR is defined as the best observed response for each subject up to and including the EOT.
    Reponses of PR or CR should be confirmed by a repeat assessment at least 4 weeks later.
    • PFS: PFS is defined as the time from treatment initiation until objective tumor progression or death. Subjects who have no PFS events will be
    censored at the date of the last adequate tumor assessment. If the subject has no post-baseline tumor assessments, they will be censored
    at the time of enrollment.
    • TTP: TTP is defined as the time from treatment initiation until objective tumor progression or death due to PD. Subjects who have not
    progressed will be censored at the date of the last adequate tumor assessment. If the subject has no post-baseline tumor assessments but
    was known to be alive, they will be censored at the time of enrollment.
    • Duration of response: Duration of response, in responders, is defined as the period from the date of initial PR or CR until the date of PD or
    death from any cause. Only subjects with BOR of CR or PR (i.e., responders) will be included in the analysis of duration of response.
    Subjects with no documented progression or death after CR or PR will be censored at the last date at which they are known to have had the CR or PR.

    Safety endpoints
    The following safety endpoints will be assessed among evaluable subjects as well as all subjects enrolled and treated: AEs and concomitant medications, laboratory examinations (clinical chemistry, hematology, and urinalysis), physical examinations, vital signs, ECOG performance status.

    Pharmacokinetic endpoints: plasma concentrations of GTx-024 18 mg
    and GTx-024 glucuronide at each assessment.


    • To assess overall Survival: Median OS and 95% confidence intervals
    will be estimated by the Kaplan-Meier method and the survival function and associated 95% confidence intervals will be constructed at key time points. Follow up will be up to 24 months post treatment initiation for each subject and subjects alive at that time will be censored.
    E.5.2.1Timepoint(s) of evaluation of this end point
    week 16
    week 24
    during treatment period after week 24
    up to 12 months post treatment
    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) 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.8.2.4Number 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 EEA24
    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
    Bulgaria
    Czech Republic
    Hungary
    Lithuania
    Romania
    Ukraine
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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: 45
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 55
    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 who continue to demonstrate a beneficial response from the study treatment at 12 months will be offered to continue in a safety extension study under a separate protocol.
    Subjects who are withdrawn or complete the study, but do not continue to demonstrate responce to GTx-024 will continue according to the standard of care of the country.
    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 Decision2015-07-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-08-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-05-18
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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