EUCTR2011-001792-39-HU进行中（未招募）不适用
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
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- GTx, Inc.
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Give voluntary, signed informed consent in accordance with institutional policies
- •- Be non-obese as defined as body mass index (BMI) = 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 = 1
- •- Serum creatinine = 2.0 mg/dL
- •- MALES – age = 30 years
- •- FEMALES – age = 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 >6 months but <12 months they must have a serum FSH concentration of = 50 mIU/mL and an estradiol concentration of = 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 = 4.0 ng/mL or a negative prostate biopsy (no prostate cancer) within 6 months of evaluation
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 120
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 180
排除标准
- •- 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 (Iressa®) 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 cannibis) or any prescription medication intended to increase appetite or treat unintentional weight loss (any such products must be discontinued prior to randomization).
- •- Have a baseline stair climb time = 30 seconds (mean of two stair climbs)
- •- Have active cancer, other than NSCLC or non-melanoma carcinoma of the skin, within previous two years
研究者
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