Phase 3
N=330
Effect of GTx-024 on Muscle Wasting in Patients With Non-Small Cell Lung Cancer (NSCLC) on First Line Platinum
Muscle Wasting · Non-Small Cell Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01355497 ↗Enrolled (actual)
330
Serious AEs
67.3%
Results posted
Nov 2020
Primary outcome: Primary: Physical Function — 19.5; 24.8 percentage of subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- GTx-024 (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- GTx
- Primary completion
- May 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Physical Function |
19.5; 24.8 | — |
| PRIMARY Lean Body Mass |
46.5; 37.9 | — |
Summary
The purpose of this study is to determine if the investigational drug GTx-024 can help patients with non small cell lung cancer increase physical function and maintain or gain muscle.
Eligibility Criteria
Inclusion Criteria
- give voluntary, signed informed consent in accordance with institutional policies
- be non-obese as defined as body mass index (BMI) 6 months
- ECOG score 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 or=50 mIU/mL and an estradiol concentration of 10 years prior to enrollment and no evidence of active liver disease
- 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.
Data sourced from ClinicalTrials.gov (NCT01355497). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.