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Phase III Study of the Effect of GTx-024 on Muscle Wasting in Patients With Non-Small Cell Lung Cancer (NSCLC) | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Phase III Study of the Effect of GTx-024 on Muscle Wasting in Patients With Non-Small Cell Lung Cancer (NSCLC)

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

NCT01355484•GTx

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine if the investigational drug GTx-024 can help subjects with non-small cell lung cancer increase physical function and maintain or gain muscle, also called "lean body mass".

Detailed Description

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.

Eligibility

Age

30 - No limit years

Sex

ALL

Healthy Volunteers

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 \<or=1
•Serum creatinine \<or=2.0 mg/dL
•MALES - age \>or= 30 years
+3 more criteria

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
+2 more criteria

Locations (27)

GTx Investigative Site

Birmingham, Alabama, United States

GTx Investigative Site

Long Beach, California, United States

GTx Investigative Site

Aventura, Florida, United States

GTx Investigative Site

Miami, Florida, United States

GTx Investigative Site

Orange City, Florida, United States

GTx Investigative Site

Tampa, Florida, United States

GTx Investigative Site

Decatur, Illinois, United States

GTx Investigative Site

Peoria, Illinois, United States

GTx Investigative Site

Skokie, Illinois, United States

GTx Investigative Site

Indianapolis, Indiana, United States

Key Dates

Start Date

July 1, 2011

Primary Completion Date

May 1, 2013

Completion Date

June 1, 2014

Last Updated

March 3, 2016

Enrollment

321

ACTUAL participants

Conditions

Muscle WastingNon Small Cell Lung Cancer

Interventions

GTx-024

DRUG

placebo

DRUG

Association Between Galectin-3 Levels and Outcomes in Patients With Renal Cell Carcinoma, Transitional Cell Carcinoma , Non Small Cell Lung Cancer, and Hepatocellular Carcinoma, Treated With PD-1/PDL-1 Inhibitors

NCT07485114

Renal Cell Carcinoma (Kidney Cancer)Non Small Cell Lung Cancer+2 more

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NCT06066138

Locally Advanced Alveolar Soft Part SarcomaMetastatic Alveolar Soft Part Sarcoma+8 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 3, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Phase III Study of the Effect of GTx-024 on Muscle Wasting in Patients With Non-Small Cell Lung Cancer (NSCLC)

Inclusion Criteria

Exclusion Criteria

Association Between Galectin-3 Levels and Outcomes in Patients With Renal Cell Carcinoma, Transitional Cell Carcinoma , Non Small Cell Lung Cancer, and Hepatocellular Carcinoma, Treated With PD-1/PDL-1 Inhibitors

A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

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A Study to Evaluate the Benefit of Adding Durvalumab After Chemotherapy, Durvalumab and Surgery in Patients With Early-stage, Operable, Non-small Cell Lung Cancer.

Reduced CT + Anti-PD-1 as First Line Tx in Vulnerable Older Adults w/Adv <50% PD-L1 Non-Small Cell Lung Cancer (NSCLC)

A Study to Compare Pharmacokinetics, Efficacy, Safety, and Immunogenicity of MB12 (Proposed Pembrolizumab Biosimilar) to Keytruda® in Non-small Cell Lung Cancer (BENITO Study)