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    The EU Clinical Trials Register currently displays   36115   clinical trials with a EudraCT protocol, of which   5940   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2011-001792-39
    Sponsor's Protocol Code Number:G300505
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-09-23
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2011-001792-39
    A.3Full title of the trial
    Phase III, Randomized, Double-Blind, Placebo-Controlled Study of the Effect of GTx-024 on Muscle Wasting in Patients with Non-Small Cell Lung Cancer on First Line Platinum Plus a Non-Taxane Chemotherapy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial to study the effect of GTx-024 on muscle waste in patients who are diagnosed with Non Small Cell Lung Cancer and who are prior to starting their first chemotherapy, i.e. a Platinum and a Non-Taxane based chemotherapy.
    A.4.1Sponsor's protocol code numberG300505
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01355497
    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 pointJoye O`Rourke
    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+19015076943
    B.5.5Fax number+19012718679
    B.5.6E-mailjorourke@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.3.2Product code GTx-024
    D.3.4Pharmaceutical form
    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 INNOstarine
    D.3.9.1CAS number 1202044-20-9
    D.3.9.2Current sponsor codeGTx-024
    D.3.9.3Other descriptive nameMK-2866
    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
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Cachexia, muscle wasting in patients with Non-Small Cell Lung Cancer
    E.1.1.1Medical condition in easily understood language
    Accelerated loss of skeletal muscle and body weight in patients with lung cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10025054
    E.1.2Term Lung cancer non-small cell stage IIIB
    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 14.0
    E.1.2Level LLT
    E.1.2Classification code 10025048
    E.1.2Term Lung cancer non-small cell 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 14.0
    E.1.2Level LLT
    E.1.2Classification code 10025055
    E.1.2Term Lung cancer non-small cell stage IV
    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 assess the efficacy of GTx-024 on physical function
    To assess the efficacy of GTx-024 on total LBM (overall LBM)
    E.2.2Secondary objectives of the trial
    - To assess the durability of effect of GTx-024 on physical function
    - To assess the durability of effect of GTx-024 on total lean body mass (LBM)
    - To assess the change from baseline in physical function in the GTx-024 treatment group compared to placebo
    - To assess the change from baseline in total LBM in the GTx-024 treatment group compared to placebo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Give voluntary, signed informed consent in accordance with institutional policies
    - Be non-obese as defined as body mass index (BMI) ≤ 32 and weight < 300 pounds (< 136 kg)
    - Have been diagnosed with Stage III or IV NSCLC
    - Be prior to first line chemotherapy
    - Planned first line chemotherapy regimen is platinum plus gemcitabine only or platinum plus vinorelbine only or platinum plus pemetrexed only
    - If surgery is part of the cancer treatment, screening for this study should be conducted at least 4 weeks (28 days) after surgery
    - Life expectancy of > 6 months
    - ECOG score ≤ 1
    - Serum creatinine ≤ 2.0 mg/dL
    - MALES – age ≥ 30 years
    - FEMALES – age ≥ 30 years and clinically confirmed as postmenopausal. Subjects must have undergone the onset of spontaneous or surgical menopause prior to the start of this
    study. Spontaneous menopause is defined as the natural cessation of ovarian function as indicated by being amenorrheic for at least 12 months. If the subject has been amenorrheic for >6 months but <12 months they must have a serum FSH concentration of ≥ 50 mIU/mL and an estradiol concentration of ≤ 25 pg/mL. Surgical menopause is
    defined as bilateral oophorectomy.
    - MALES – Subjects must agree to use a double barrier method of contraception during the study and for 3 months after study completion. This may include the following: condom + spermicide or condom + oral hormonal contraception
    - MALES – have a serum PSA of ≤ 4.0 ng/mL or a negative prostate biopsy (no prostate cancer) within 6 months of evaluation
    E.4Principal exclusion criteria
    - 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
    - Have ALT/SGOT or AST/SGPT above 1.5 times the upper limit of normal (ULN) without evidence of liver metastases and above 5 times the ULN in subjects with evidence of liver metastases
    - Have alkaline phosphatase greater than 3 times ULN and/or total bilirubin levels above 2 mg/dL at baseline
    - Have biologic agents or kinase inhibitors as part of their first line chemotherapy regimen including, but not limited to bevacizumab (Avastin®), gefitinib (Iressa®) and erlotinib (Tarceva®)
    - Cardiovascular: uncontrolled hypertension, congestive heart failure or angina
    - Pulmonary: Stage 4 chronic obstructive pulmonary disease (COPD)
    - Positive screen for Hepatitis B consisting of HBsAg (Hepatitis B Surface Antigen), unless subject was diagnosed > 10 years prior to enrollment and no evidence of active liver disease
    - Positive screen for anti-HCV (Hepatitis C Antibody), hepatitis A antibody IgM, or HIV
    - Currently taking testosterone, oxandrolone (Oxandrin®), testosterone-like agents (such as dehydroepiandrosterone (DHEA), androstenedione, and other androgenic compounds, including herbals), or antiandrogens; previous therapy with testosterone and
    testosterone-like agents is acceptable with a 30 day washout (if previous testosterone therapy was long term depot within the past 6 months, the site should contact the medical monitor for this study to determine appropriate washout period)
    - Currently taking megestrol acetate (Megace®), dronabinol (Marinol®), medical marijuana (medical cannibis) or any prescription medication intended to increase appetite or treat unintentional weight loss (any such products must be discontinued prior to randomization).
    - Have a baseline stair climb time ≥ 30 seconds (mean of two stair climbs)
    - Have active cancer, other than NSCLC or non-melanoma carcinoma of the skin, within previous two years
    E.5 End points
    E.5.1Primary end point(s)
    Physical function will be ascertained by stair climb power (SCP) at Day 84. The percent change from baseline SCP will be computed to determine if the subject is a physical function responder. A subject is considered a responder if he/she has a Day 84 SCP assessment and at least a 10% increase in power compared to baseline. A subject is considered a nonresponder in physical function if they do not meet both of these criteria.
    Total LBM at Day 84 will be ascertained. A subject is considered a responder if he/she has a Day 84 LBM assessment and no loss in LBM compared to baseline. A subject is considered a nonresponder in total LBM if they do not meet both of these criteria.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 84
    E.5.2Secondary end point(s)
    1. Physical function will be ascertained by SCP at Day 147 to determine if a subject who responded at Day 84 had a durable response to the physical function test
    2. Total LBM will be ascertained at Day 147 to determine if a subject who responded at Day 84 had a durable response with respect to total LBM
    3. Physical function will be ascertained by SCP at Day 84 to calculate each subject’s change in SCP from baseline and compute the mean change in SCP for each arm
    4. Total LBM will be ascertained at Day 84 to calculate each subject’s change in LBM from baseline and compute the mean change in LBM for each arm
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 147
    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 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 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 concerned15
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA27
    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
    Chile
    Hungary
    Peru
    Poland
    Russian Federation
    Ukraine
    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
    Day 147: Last visit of the last subject undergoing the trial;

    After Day 147: the subjects will be followed for vital status. These data will be collected by chart review or by phone every one (1) month starting when the subject completes the Day 147/End of Study Intervention visit. The follow up period is expected to be up to 30 months from the start of this study (first patient first visit).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    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: 120
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 180
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations 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 state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 220
    F.4.2.2In the whole clinical trial 300
    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)
    After the end of the trial the patient will continue to receive standard therapy according to the investigator`s discretion.
    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 Decision2011-09-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-09-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-06-25
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