NCT02950103终止2 期
Efficacy and Safety Evaluation of Synthetic Phosphoethanolamine in Solid Tumor Patients
Secretaria de Estado da Saúde1 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2016年8月最近更新:
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
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- RECIST v 1.1 response rate or specific criteria for prostate cancer
研究概览
简要总结
Synthetic phosphoethanolamine is a primary amine which has a critical role in the biosynthesis of cell membranes. Pre-clinical models have shown potential anticancer activity.
详细描述
Phase II multi-cohort study based on two-stage Simon design. The primary goal of the study is response rate at 8 weeks in participants with advanced solid tumors treated with synthetic phosphoethanolamine, as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v 1.1) or specific criteria for 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
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proven advanced solid tumor patients (recurrent or metastatic), not amenable to curative therapy. Patients must have progressed to standard treatment proven to prolong survival or no standard treatment exists. Tumor types include head and neck squamous cell carcinoma, non-small cell lung cancer, colorectal adenocarcinoma, breast cancer, cervix cancer, prostate cancer, melanoma, pancreas adenocarcinoma, gastric adenocarcinoma, hepatocellular carcinoma
- •No concurrent active systemic treatment
- •Measurable disease by RECIST v1.1
- •Clinical or radiological progression in the last three months
- •Eastern Cooperative Oncology Group Performance Status 0-1
- •Ability to consent
- •Adequate organ function
- •Life expectancy greater than 12 weeks
- •Ability to swallow
- •No previous malignancy in the last 5 years
排除标准
- •Pregnancy
- •Corticosteroid therapy for prostate cancer
- •Uncontrolled comorbidity
- •Known hepatitis B, C and HIV
- •Central nervous system involvement, except if controlled symptoms and without corticosteroids
- •Previous use of phosphoethalonamine
研究组 & 干预措施
Synthetic phosphoethalonamine
Experimental
Phosphoethanolamine PO daily
干预措施: Phosphoethanolamine (Drug)
结局指标
主要结局
RECIST v 1.1 response rate or specific criteria for prostate cancer
时间窗: 8 weeks
次要结局
- Treatment related toxicities as determined by CTCAE version 4.0(Every cycle, up to 30 days after drug interruption)
- Overall survival(Survival followed every 2 months from inclusion until death, withdrawal, loss to follow-up, or study end for up to 60 months)
- Disease free survival(Tumor assessment by RECIST v1.1 or prostate cancer specific criteria every 8 weeks for up to 12 months, then every 12 weeks until loss of clinical benefit, withdrawal, death, or study end for up to 24 months)
研究者
研究点 (1)
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