CompletedPhase 3NCT01355497

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

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.

Checked against the public recordLast updated Nov 9, 2020 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 3
U.S. locations30
SponsorGTx
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 3
Sponsor
GTx
Interventions being studied
Drug: GTx-024; Drug: placebo
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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 \<or=25 pg/mL. 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • GTx Investigative SiteBirmingham, Alabama
  • GTx Investigative SiteScottsdale, Arizona
  • GTx Investigative SiteLa Jolla, California
  • GTx Investigative SiteLong Beach, California
  • GTx Investigative SiteMiami, Florida
  • GTx Investigative SiteOrange City, Florida
  • GTx Investigative SiteTampa, Florida
  • GTx Investigative SiteDecatur, Illinois
  • GTx Investigative SitePeoria, Illinois
  • GTx Investigative SiteSkokie, Illinois
  • GTx Investigative SiteGoshen, Indiana
  • GTx Investigative SiteIndianapolis, Indiana

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 9, 2020. Always confirm current availability with the study team.

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