Effect of GTx-024 on Muscle Wasting in Patients With Non-Small Cell Lung Cancer (NSCLC) on First Line Platinum



Status:Completed
Conditions:Lung Cancer, Cancer, Neurology
Therapuetic Areas:Neurology, Oncology
Healthy:No
Age Range:30 - Any
Updated:10/14/2017
Start Date:July 2011
End Date:June 2014

Use our guide to learn which trials are right for you!

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

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.

This is a randomized, double blind, placebo controlled, multicenter, multinational efficacy
and safety study in subjects with non small cell lung cancer. 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 (LBM) 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 = 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 < 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 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

- 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.
We found this trial at
30
sites
Concord, Massachusetts 01742
2563
mi
from 91732
Concord, MA
Click here to add this to my saved trials
Ashland, Kentucky 41101
1981
mi
from 91732
Ashland, KY
Click here to add this to my saved trials
Birmingham, Alabama 35211
1784
mi
from 91732
Birmingham, AL
Click here to add this to my saved trials
Burlington, North Carolina 27215
2171
mi
from 91732
Burlington, NC
Click here to add this to my saved trials
Canfield, Ohio 44406
2079
mi
from 91732
Canfield, OH
Click here to add this to my saved trials
4875 Higbee Ave NW
Canton, Ohio 44718
330-492-3345
Gabrail Cancer Center Since 1990, Gabrail Cancer Center has built a national reputation for excellence...
2044
mi
from 91732
Canton, OH
Click here to add this to my saved trials
Decatur, Illinois 62526
1645
mi
from 91732
Decatur, IL
Click here to add this to my saved trials
Flat Rock, North Carolina 28731
2012
mi
from 91732
Flat Rock, NC
Click here to add this to my saved trials
Goshen, Indiana 46526
1815
mi
from 91732
Goshen, IN
Click here to add this to my saved trials
Great Falls, Montana 59405
991
mi
from 91732
Great Falls, MT
Click here to add this to my saved trials
Indianapolis, Indiana 46260
1793
mi
from 91732
Indianapolis, IN
Click here to add this to my saved trials
LaJolla, California 92093
?
mi
from 91732
LaJolla, CA
Click here to add this to my saved trials
Lancaster, Pennsylvania 17604
2313
mi
from 91732
Lancaster, PA
Click here to add this to my saved trials
Long Beach, California 90813
23
mi
from 91732
Long Beach, CA
Click here to add this to my saved trials
Miami, Florida 33133
2322
mi
from 91732
Miami, FL
Click here to add this to my saved trials
Nashville, Tennessee 37203
1763
mi
from 91732
Nashville, TN
Click here to add this to my saved trials
Orange City, Florida 32763
2179
mi
from 91732
Orange City, FL
Click here to add this to my saved trials
Peoria, Illinois 61615
1616
mi
from 91732
Peoria, IL
Click here to add this to my saved trials
Portland, Oregon 97213
827
mi
from 91732
Portland, OR
Click here to add this to my saved trials
Rochester, New York 14642
2245
mi
from 91732
Rochester, NY
Click here to add this to my saved trials
Round Rock, Texas 78665
1210
mi
from 91732
Round Rock, TX
Click here to add this to my saved trials
Sandusky, Ohio 44870
1979
mi
from 91732
Sandusky, OH
Click here to add this to my saved trials
Scottsdale, Arizona 85255
352
mi
from 91732
Scottsdale, AZ
Click here to add this to my saved trials
Skokie, Illinois 60076
1726
mi
from 91732
Skokie, IL
Click here to add this to my saved trials
Spartanburg, South Carolina 29303
2043
mi
from 91732
Spartanburg, SC
Click here to add this to my saved trials
St Clair Shores, Michigan 48081
1975
mi
from 91732
St Clair Shores, MI
Click here to add this to my saved trials
Tampa, Florida 33612
2134
mi
from 91732
Tampa, FL
Click here to add this to my saved trials
Tupelo, Mississippi 38801
1669
mi
from 91732
Tupelo, MS
Click here to add this to my saved trials
Wilmington, North Carolina 28401
2275
mi
from 91732
Wilmington, NC
Click here to add this to my saved trials
Winston Salem, North Carolina 27103
2122
mi
from 91732
Winston Salem, NC
Click here to add this to my saved trials