A Phase II Trial of NRX 194204 in Castration- and Taxane-Resistant Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Clinical Benefit of NRX 194204 in Men With Castration- and Taxane-resistant Metastatic Prostate Cancer
研究概览
简要总结
This study is to evaluate the benefits of investigational drug, NRX 194204 in slowing down/stopping/reversing progression of the castration resistant and taxane resistant prostate cancer.
详细描述
Numerous studies in pre-clinical models and in human clinical trials have clearly established the potential for the use of rexinoids in the treatment and prevention of cancer. NRX 194204, a second generation rexinoid, is a highly potent and specific activator of RXRs (retinoid X receptors). Because NRX 194204 is significantly more selective for the RXRs relative to the RARs (retinoic acid receptors) than a first generation approved drug, it is associated with fewer adverse events in clinical use. This study seeks to investigate NRX 194204 monotherapy in patients with castration- and taxane- resistant prostate cancer.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed prostate cancer
- •Documented progression on at least one prior hormone treatment, AND at least one taxane based chemotherapy regimen, or patient's refusal of chemotherapy treatment
- •Male, Age > 18 years
- •ECOG (Eastern Cooperative Oncology Group) performance score of 0-2
- •Adequate bone marrow, renal and hepatic function
- •Men of childbearing potential must consent to use barrier contraception while on treatment and for 90 days thereafter
排除标准
- •Prior treatment with NRX 194204 or bexarotene (Targretin)
- •Presence of parenchymal brain metastases
- •History of prior malignancy within the past 5 years with the exception of curatively treated basal cell or squamous cell carcinoma of the skin or superficial bladder or other stage I or stage II cancer in complete remission for at least 12 months
- •Patients with a history of unstable or newly diagnosed angina pectoris, documented history of current serious arrhythmia or congestive heart failure or myocardial infarction within 6 months of enrollment
- •Known HIV or hepatitis B or C infection
- •Life expectancy < 3 months
- •Patients with any history of thyroid disease, pituitary disease or treatment with thyroid replacement hormone
- •Patients with a history of pancreatitis or at significant risk of developing pancreatitis
研究组 & 干预措施
NRX 194204
This was a single arm open-label study. All patients enrolled received 20 mg of IRX4204 per day orally, for six months, or longer if the patient had disease stabilization and was tolerating the experimental treatment.
干预措施: NRX 194204 (Drug)
结局指标
主要结局
Clinical Benefit of NRX 194204 in Men With Castration- and Taxane-resistant Metastatic Prostate Cancer
时间窗: participants will be followed for the duration of treatment and follow up, which is up to 2.5 years
Clinical benefit will be defined as either non-progression at 8 weeks or radiologic and/or PSA response at any time point with no dose limiting toxicity (DLT) or other toxicity requiring termination of treatment.
次要结局
- Overall Survival(participants will be followed for the duration of treatment and follow up, which is up to 2.5 years)
- Time to Disease Progression(participants were to be followed for the duration of treatment and follow up; for up to 2.5 years from baseline)
- Number of Grade 3 and Higher Adverse Events Deemed at Least Possibly Related to NRX 194204(participants will be followed for the duration of treatment and follow up, which is up to 2.5 years)
- PSA Response Rate(participants will be followed for the duration of treatment and follow up, which is up to 2.5 years)