NCT01420861终止2 期
Open Label Study of the Effect of GTx-758 on Serum PSA and Free Testosterone Levels in Men With Castration Resistant Prostate Cancer and Maintained on Androgen Deprivation Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- GTx
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Decline in Serum PSA
研究概览
简要总结
The purpose of this study is to assess the effect of GTx-758 on Serum Prostate-specific antigen (PSA) levels in men with castrate resistant prostate cancer who are maintained on androgen deprivation therapy (Serum PSA response and Serum PSA progression)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Be over 18 years of age
- •Be able to communicate effectively with the study personnel
- •Have histologically confirmed prostate cancer
- •ECOG performance status of 0 to 2
- •Have been treated with ADT(chemical or surgical) for at least 6 months
- •Have castrate level of serum total testosterone (<50 ng/dL)
- •Have a history of serum PSA response after initiation of ADT, serum PSA response is at least a 90% reduction in serum PSA to <10 ng/mL OR undetectable level of serum PSA (less tan or =0.2 ng/mL)
- •Have rising serum PSA on two successive assessments at least 2 weeks apart and serum PSA levels ≥ 2 ng/mL or 2ng/mL and a 25% increase over the nadir after the initiation of ADT
- •Be continued on androgen deprivation therapy throughout this study
- •Give written informed consent prior to any study specific procedures
- •Subjects must agree to use acceptable methods of contraception:
- •oIf their female partners are pregnant or lactating acceptable methods of contraception from the time of the first administration of study medication until 3 months following administration of the last dose of study medication must be used. Acceptable methods are: Condom used with spermicidal foam/gel/film/cream/suppository. If the subject has undergone surgical sterilization (vasectomy with documentation of azospermia) a condom with spermicidal foam/gel/film/cream/suppository should be used. oIf the male subject's partner could become pregnant, use acceptable methods of contraception from the time of the first administration of study medication until 3 months following administration of the last dose of study medication. Acceptable methods of contraception are as follows: Condom with spermicidal foam/gel/film/cream/suppository [i.e. barrier method of contraception], surgical sterilization (vasectomy with documentation of azospermia) and a barrier method {condom used with spermicidal foam/gel/film/cream/suppository}, the female partner uses oral contraceptives (combination estrogen/progesterone pills), injectable progesterone or subdermal implants and a barrier method {condom used with spermicidal foam/gel/film/cream/suppository}. oIf the female partner has undergone documented tubal ligation (female sterilization), a barrier method {condom used with spermicidal foam/gel/film/cream/suppository} should also be used. oIf the female partner has undergone documented placement of an intrauterine device (IUD) or intrauterine system (IUS) and a barrier method {condom with spermicidal foam/gel/film/cream/suppository} should also be used.
排除标准
- •Known hypersensitivity or allergy to estrogen or estrogen like drugs;
- •Have symptomatic metastatic prostate cancer
- •Any disease or condition (medical or surgical) which might compromise the hematologic, cardiovascular, endocrine, pulmonary, renal, gastrointestinal, hepatic, or central nervous system; or other conditions that may interfere with the absorption, distribution, metabolism or excretion of study drug, or would place the subject at increased risk;
- •History of abnormal blood clotting, Factor V Leiden clotting disorder, thrombotic disease (venous or arterial thrombotic events such as history of stroke, deep vein thrombosis (DVT), and/or pulmonary embolus (PE))
- •Symptomatic congestive heart failure (NYHA Class III - IV), unstable angina pectoris, cardiac arrhythmia
- •The presence of consistently abnormal laboratory values which are considered clinically significant. In addition, no subject with liver enzymes (ALT or AST) above 2 times the ULN, total bilirubin above 2 times the ULN, or serum creatinine above 1.5 ULN will be admitted to the study
- •Received an investigational drug within a period of 90 days prior to enrollment in the study
- •Received the study medication previously
- •Currently taking testosterone, testosterone-like agents, or antiandrogens,including 5-alpha reductase inhibitors (may be eligible if allow a 6 week washout period after stopping antiandrogens);
- •History of prior treatment of cancer chemotherapy agent (other than hormone therapy) or radiopharmaceutical for prostate cancer.
- •Have taken ketoconazole within the previous 12 months prior to randomization into this study
- •Have taken diethylstilbestrol or other estrogen products, ketoconazole, or abiraterone within the previous 12 months prior to randomization into this study
- •Have taken body building or fertility supplements within 4 weeks of admission into the study
- •Have been previously diagnosed with cancer (other than prostate cancer, superficial bladder cancer, or non-melanoma skin cancer).
研究组 & 干预措施
1000 mg GTx-758 BID
Experimental
subjects will receive daily doses of 1000 mg GTx-758
干预措施: GTx-758 (Drug)
结局指标
主要结局
Decline in Serum PSA
时间窗: 30 days
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
已完成
2 期
Study of the Effect of GTx-758 on Serum PSA and Testosterone in Men With Prostate CancerProstate CancerNCT01615120GTx77
已完成
不适用
68Ga-PSMA PET in Diagnosing Metastasis in Patients With Ovarian CancerOvarian CarcinomaNCT03857087University of California, San Francisco7
招募中
不适用
68Ga-P3 PET/CT Imaging in ProstateNeoplasmsNCT05940259Peking University First Hospital30
招募中
不适用
68Ga-P3 PET/CT Imaging in MalignancyNeoplasmsNCT05887687Peking University First Hospital350
终止
2 期
Gallium-68 Prostate Specific Membrane Antigen PET in Diagnosing Patients With Thyroid CancerThyroid Gland CarcinomaNCT03463889University of California, San Francisco12