Phase III Study of the Effect of GTx-024 on Muscle Wasting in Patients With Non-Small Cell Lung Cancer (NSCLC)
Condition: Muscle Wasting; Non Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Muscular Atrophy; Wasting Syndrome; Cachexia
Intervention: GTx-024; placebo
Intervention description: subjects will be randomized to receive GTx-024 for the full duration of the trial.; subject will receive placebo for the duration of the trial
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 321.0
Sex: All
Minimum age: 30 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if the investigational drug GTx-024 can help
      subjects with non-small cell lung cancer increase physical function and maintain or gain
      muscle, also called "lean body mass".
    

Eligibility criteria:

        Inclusion Criteria:

          -  give voluntary, signed informed consent in accordance with institutional policies

          -  be non-obese as defined as body mass index (BMI)< or = to 32 and weight <300 pounds
             (<136kg)

          -  have been diagnosed with Stage III or IV NSCLC

          -  be prior to first line chemotherapy

          -  planned first line chemotherapy regimen is platinum plus paclitaxel only or platinum
             plus docetaxel 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 <or=1

          -  Serum creatinine <or=2.0 mg/dL

          -  MALES - age >or= 30 years

          -  FEMALES - age >or=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 >or=6 months but <12 months they must have a serum FSH
             concentration of >or=50 mIU/mL and an estradiol concentration of <or=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 <or=4.0 ng/mL or a negative prostate biopsy (no prostate
             cancer)within 6 months of evaluation

        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 (Nexavar) 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 cannabis) or any prescription medication intended to increase appetite or
             treat unintentional weight loss

          -  have a baseline stair climb time >or=30 seconds (mean of two stair climbs)

          -  Have active cancer, other than NSCLC, or non-melanoma carcinoma of the skin, within
             the previous two years