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    The EU Clinical Trials Register currently displays   38002   clinical trials with a EudraCT protocol, of which   6235   are clinical trials conducted with subjects less than 18 years old.
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    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    EudraCT Number:2015-001012-35
    Sponsor's Protocol Code Number:G200802
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2015-07-27
    Trial results
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedBulgarian Drug Agency
    A.2EudraCT number2015-001012-35
    A.3Full title of the trial
    A Phase 2 Open Label, Multi-Center, Multinational, Randomized, Parallel Design Study Investigating The Efficacy and Safety Of GTx-024 On Metastatic or Locally Advanced ER+/AR+ Breast Cancer (BC) in Postmenopausal Women
    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 Estrogen Receptor Positive and Androgen Receptor Positive Breast Cancer
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberG200802
    A.5.4Other Identifiers
    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
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    Estrogen Receptor Positive and Androgen Receptor Positive Breast Cancer
    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 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 LLT
    E.1.2Classification code 10070575
    E.1.2Term Estrogen receptor positive 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 10072740
    E.1.2Term Locally 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 PT
    E.1.2Classification code 10070577
    E.1.2Term Oestrogen receptor positive 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 24 weeks (defined as CR, PR, or SD) (by RECIST 1.1) of GTx-024 9 mg and of GTx-024 18 mg given PO daily in subjects with ER+/AR+ BC who have centrally confirmed AR+ status.
    E.2.2Secondary objectives of the trial
    Secondary efficacy objectives:
     Estimate the CBR at 24 weeks (by RECIST 1.1) of GTx-024 9 mg and 18 mg in all subjects randomized who receive at least one dose of study medication (the FAS)
    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 theFAS) 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 9 mg and 18 mg at 24 weeks
     Estimate the best overall response rate (BOR) of GTx-024 9 mg and 18 mg
     Estimate the progression free survival (PFS) of subjects receiving GTx-024 9 mg and 18 mg
     Estimate the time to progression (TTP) of subjects receiving GTx-024 9 mg and 18 mg
     Estimate duration of response (time from documentation of tumor response to disease progression or death) of subjects receiving GTx-024 9 mg and 18 mg

    Safety objective
    Pharmacokinetic objective
    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 postmenopausal women with metastatic or recurrent locally advanced ER+/AR+ BC.
    Subject Inclusion criteria: Subjects eligible for inclusion in this study must meet all of the following criteria:
    1. Adult women (≥ 18 years of age) with metastatic orrecurrent locally advanced BC, not amenable to curative treatment by surgery or radiotherapy, with objective
    evidence of disease progression.
     Women must have received ≥ 1 prior hormonal treatment(s) in the metastatic or adjuvant setting.
     - If the most recent hormonal treatment was in the metastatic setting, duration of response (tumor regression or stabilization of disease) to this specific course of therapy must be ≥ 6 months
    - If the most recent hormonal treatment was in the adjuvant setting, duration of response (disease free) to this specific course of therapy must be ≥ 3 years
    2. Histological or cytological confirmation of ER+ BC as assessed by a local laboratory using slides, paraffin blocks, or paraffin sample or by medical history: ER+ (confirmed as ER expression more than or equal to 1%
    positive tumor nuclei)
    3. Human epidermal growth factor receptor 2 (HER2)-negative tumor by local laboratory testing (immunohistochemistry [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)
    4. Availability of paraffin embedded or formalin fixed tumor tissue; OR, a minimum of 10 and up to 20 slides of archived tumor tissue for central laboratory confirmation of AR status and molecular subtyping. Metastatic tumor
    tissue is preferred when possible
    5. Postmenopausal women. Postmenopausal status is defined by the National Comprehensive Cancer Network as either:
    - Age ≥ 55 years and one year or more of amenorrhea
    - Age < 55 years and one year or more of amenorrhea, with an estradiol assay < 20 pg/mL
    - Age < 55 years and surgical menopause with bilateral oophorectomy
    a. Note: Ovarian radiation or treatment with a luteinizing hormone-releasing hormone (LH-RH) agonist (goserelin acetate or leuprolide acetate) is not permitted for induction of ovarian suppression at the time of screening. Long term use (> 6 months prior to screening) is permitted.
    6. Radiological or clinical evidence (bone scan, computerized tomography [CT], and magnetic resonance Imaging [MRI]) of recurrence or progression within
    30 days before randomization
    7. Subject must have either measurable disease or bone-only non-measurable disease, evaluable according to RECIST 1.1
    8. Adequate organ function as shown by:
    - Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3
    - Platelet count ≥ 100,000 cells/mm3
    - Hemoglobin (Hgb) ≥ 9.0 g/dL
    - Serum aspartate aminotransferase (AST) and alanine transaminase (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 (aPTT) < 1.5 × ULN (unless on anticoagulant treatment at screening)
    9. Subject has an Eastern Cooperative Oncology Group (ECOG) performance status 4 0 or 1
    10. 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 subjects intolerance to these therapies. For patients, who are normocalcemic, therapy could be initiated at the time patient initiates study drug.
    11. Subject is able to swallow capsules
    12. Able and willing to give voluntary, written and signed informed consent before any screening procedure and according to local guidelines
    E.4Principal exclusion criteria
    Subjects eligible for this study must not meet any of the following criteria:
    1. Previously received > 1 course of chemotherapy (not including immunotherapies or targeted therapies) for the treatment of metastatic BC
    a. Note: Subjects may have received 1 course of chemotherapy prior to surgery for the treatment of locally advanced disease and 1 course of chemotherapy for the treatment of metastatic BC; however, if surgery could not be performed, this
    will count as the 1 chemotherapy course allowed prior to study
    2. Known hypersensitivity to any of the GTx-024 components or subjects previously received treatment with Selective Androgen Receptor Modulator (SARM)
    3. Subjects with radiographic evidence of central nervous system (CNS) metastases as assessed by CT or MRI that are not well-controlled (symptomatic or requiring control with continuous corticosteroid therapy [e.g.,dexamethasone])
    a. Note: Subjects with CNS metastases are permitted to participate in the study if the CNS metastases are medically well-controlled and stable for at least 28 days after receiving local therapy (irradiation, surgery, etc.)
    4. Radiotherapy within 14 days prior to randomization except in case of localized radiotherapy for analgesic purpose or for lytic lesions at risk of fracture, which can then be completed within 7 days prior to randomization. Subjects must have recovered from radiotherapy toxicities prior to randomization
    5. Currently receiving hormone replacement therapy, unless discontinued prior to screening
    6. Subjects positive for Human Immunodeficiency Virus (HIV)
    7. 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 QTCB (corrected according to Bazett’s formula) 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)
    - 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.
    8. Major surgery within 28 days before randomization
    9. Positive hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infection at screening
    10. History of non-compliance to medical regimens
    11. Subjects unwilling to or unable to comply with the protocol
    12. Subject is currently receiving treatment with any agent listed on the prohibited medication list (See Section 6.6 Concomitant Medications/Treatments for complete list)
    13. Treatment with any investigational product within < 4 half-lives for each individual investigational product OR within 28 days prior to randomization
    14. Current treatment with intravenous bisphosphonates or denusomab with elevated serum calcium corrected for albumin or ionized calcium levels outside institutional normal limits at screening.
    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 24 week assessment. Tumor response isjudged relative to baseline tumor assessments. An evaluable subject will be considered to have a response of CB if the assessment indicates CR, PR, or SD. The primary assessment is among evaluable subjects in the FAS at 24 weeks in each of the 9 mg and 18 mg arms. An evaluable subject who does not have a week 24 assessment for any reason remains in the evaluable subset of the FAS and is
    considered a failure to achieve CB (CR, PR, or SD).
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 24
    E.5.2Secondary end point(s)
    Secondary efficacy endpoints
    - CBR in the FAS and PPS at 24 weeks in each of the 9 mg and 18 mg arms.
    The following secondary efficacy endpoints will be assessed among subjects in each of the 9 mg and 18 mg arms among the evaluable subjects, the FAS, and the PPS:
    - ORR (CR or PR assessed by RECIST 1.1 criteria) at 24 weeks
    - 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 CR or PR should be confirmed by a repeat assessment at least 4 weeks later.
    - PFS: PFS is defined as the time from randomization until objective tumor progression or death due to any cause. 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 randomization
    - TTP: TTP is defined as the time from randomization until objective tumor progression or death due to disease progression. 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 is known to be alive, they
    will be censored at the time of randomization
    - Duration of response: Duration of response, in responders, is defined as the period from the date of initial CR or PR until the date of disease progression 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
     - Eye examinations

    Pharmacokinetic endpoints
     Plasma concentrations of GTx-024 18 mg and GTx-024 glucuronide at each assessment
    E.5.2.1Timepoint(s) of evaluation of this end point
    week 24 for the secondary efficacy objectives

    Safety: at all times

    PK: baseline(V2), V3, V5, V6
    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 Yes
    E.6.13.1Other scope of the trial description
    future sample storage as an optional procedure
    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. 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 Yes
    E.8.1.1Randomised Yes
    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. trial design description
    the two groups are independent and not compared to each other
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E. description
    another concentration of GTx-024
    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 concerned3
    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
    Czech Republic
    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
    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 months0
    E.8.9.1In the Member State concerned days0
    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 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: 70
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 18
    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 No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    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 70
    F.4.2.2In the whole clinical trial 88
    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 24 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 Decision2015-10-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-09-25
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2018-12-03
    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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