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

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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
Burlington, North Carolina 27215
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Ashland, Kentucky 41101
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Birmingham, Alabama 35211
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Canfield, Ohio 44406
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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...
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Concord, Massachusetts 01742
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Decatur, Illinois 62526
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Flat Rock, North Carolina 28731
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Goshen, Indiana 46526
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Great Falls, Montana 59405
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Indianapolis, Indiana 46260
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LaJolla, California 92093
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Lancaster, Pennsylvania 17604
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Long Beach, California 90813
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Miami, Florida 33133
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Miami, FL
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Nashville, Tennessee 37203
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Orange City, Florida 32763
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Peoria, Illinois 61615
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Portland, Oregon 97213
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Portland, OR
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Rochester, New York 14642
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Round Rock, Texas 78665
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Sandusky, Ohio 44870
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Scottsdale, Arizona 85255
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Skokie, Illinois 60076
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Spartanburg, South Carolina 29303
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St Clair Shores, Michigan 48081
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Tampa, Florida 33612
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Tupelo, Mississippi 38801
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Wilmington, North Carolina 28401
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Winston Salem, North Carolina 27103
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