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 Taxane Chemotherapy
Phase 3
30 Years
N/A
30 Years
N/A
Open (Enrolling)
Both
Muscle Wasting, Non Small Cell Lung Cancer
Both
Muscle Wasting, Non Small Cell Lung Cancer
Trial Information
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 Taxane Chemotherapy
This is a randomized, double-blind, placebo controlled, multicenter, multinational efficacy
and safety study in subjects with non small cell lung cancer (NSCLC). Subjects will be
evenly randomized to placebo or GTx-024 prior to initiation of first line chemotherapy. The
primary efficacy analysis will be based on total lean body mass and physical function.
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
- Serum creatinine
- 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
- 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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
Improved Physical function
Outcome Description:
Physical function will be assessed by stair climb at Day 84.
Outcome Time Frame:
Day 84
Safety Issue:
No
Principal Investigator
Domingo Rodriguez, MD
Investigator Role:
Study Director
Investigator Affiliation:
GTx
Authority:
United States: Food and Drug Administration
Study ID:
G300504
NCT ID:
NCT01355484
Start Date:
July 2011
Completion Date:
August 2013
Related Keywords:
- Muscle Wasting
- Non Small Cell Lung Cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
- Muscular Atrophy
Name | Location |
|---|---|
| Gabrail Cancer Center | Canton, Ohio 44718 |
| GTx Investigative Site | La Mesa, California 91942 |
| GTx Investigative Site | Aventura, Florida 33180 |
| GTx Investigative Site | Springfield, Illinois 62703 |
| GTx Investigative Site | Fort Wayne, Indiana 46825 |
| GTx Investigative Site | Albany, New York 12208 |
| GTx Investigative Site | Chapel Hill, North Carolina 27514 |
| GTx Investigative Site | Cincinnati, Ohio 45212 |
| GTx Investigative Site | Bala Cynwyd, Pennsylvania 19004 |
| GTx Investigative Site | Myrtle Beach, South Carolina 29572 |
| GTx Investigative Site | Arlington, Texas 76017 |
| GTx Investigative Site | Birmingham, Alabama 35211 |
| GTx Investigative Site | Ashland, Kentucky 41101 |
| GTx Investigative Site | Concord, Massachusetts 01742 |
| GTx Investigative Site | St Clair Shores, Michigan 48081 |
| GTx Investigative Site | Tupelo, Mississippi 38801 |
| GTx Investigative Site | Great Falls, Montana 59405 |
| GTx Investigative Site | Portland, Oregon 97213 |
