Study of GTx-024 on Muscle Wasting (Cachexia) Cancer.
Condition: Cachexia
MeSH terms: Muscular Atrophy; Wasting Syndrome; Cachexia
Intervention: GTx-024; GTx-024; Placebo
Intervention description: 1 mg GTx 024; 3 mg GTx-024; Matching Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 159.0
Sex: All
Healthy volunteers: No
Keywords: Cachexia; Muscle Wasting; Non-Small Cell Lung Cancer; Colorectal Cancer; Non-Hodgkin's Lymphoma; Stage 3 or 4 Breast Cancer; Chronis Lymphocytic Leukemia

Summary:

      The purpose of this study is to assess if Gtx-024 is effective in increasing lean body mass
      in subjects with muscle wasting related to cancer.
    

Eligibility criteria:

        Inclusion Criteria:

        To be eligible for participation in this study, subjects must meet all of the following
        criteria:

          -  have been diagnosed with Stage 2, 3 or 4 non-small cell lung cancer or Stage 2, 3 or 4
             colorectal cancer or non-hodgkin's lymphoma or chronic lymphocytic leukemia or Stage 3
             or 4 breast cancer.

          -  be prior to initiation of or between cycles of chemotherapy.

          -  have experienced greater than or equal to 2% weight loss from the highest patient
             reported weight in the 6 months prior to screening for Protocol G200502 (Wt = body
             weight)

             % weight loss = (Wt at screening - highest Wt in last 6 months) / highest Wt in last 6
             months x 100%

          -  If surgery is part of the cancer treatment, screening for this study should be
             conducted at least 2 weeks (14 days) after surgery.

          -  have a life expectancy of >6 months

          -  FEMALES - be clinically confirmed as postmenopausal

          -  MALES - over 45 years of age

          -  ECOG score ≤1

        Exclusion Criteria:

        Subjects with any of the following will NOT be eligible for enrollment in this study:

          -  history of active/uncontrolled congestive heart failure, chronic hepatitis, hepatic
             cirrhosis, or HIV infection

          -  Cardiovascular: No uncontrolled hypertension

          -  Positive screen for Hepatitis B consisting of HBsAg (Hepatitis B Surface Antigen),
             anti-HCV (Hepatitis C Antibody), hepatitis A antibody IgM, or HIV

          -  Currently taking testosterone, OXANDRIN® (oxandrolone), testosterone-like agents (such
             as DHEA, androstenedione, and other androgenic compounds, including herbals), or
             antiandrogens (Please note that previous therapy with testosterone and
             testosterone-like agents is acceptable with a 30 day wash-out. However, if the
             previous testosterone therapy was a long-term depot, within the past 6 months, the
             site should call the medical monitor for this study to determine appropriate washout
             period.)

          -  Currently taking megestrol acetate (MEGACE®), dronabinol (MARINOL®), or any
             prescription medication intended to increase appetite or treat unintentional weight
             loss