NCT03448211撤回1 期
A Phase I Open-Label, Dose-Escalation Study of Para-toluenesulfonamide Injection (PTS) Administered Intratumorally and Locally to Patients With Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Maximum tolerable dose
研究概览
简要总结
The primary objective of this study is to determine the MTD of PTS following local and intratumoral injections over a treatment course of two 5-day cycles to patients with palpable advanced solid malignancies who have failed standard treatment.
详细描述
The study will be an open, uncontrolled, single-center, phase I study to assess the safety and tolerability of local intra-tumoral injection 2.0ml (660mg), 4.0ml (1220mg), 6.0ml (1880mg) and 8.0ml (2440mg) PTS in female breast cancer patients.
研究设计
- 研究类型
- Interventional
- 干预模型
- Sequential
- 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
- •Subjects are diagnosed as unsuitable for surgical operations or refuse to do so.
- •Subject's performance status is classified as Grade 0 to Grade
- •Estimated survival time should be longer than 6 months of time.
- •Physical examinations show no serious functional disorders of the heart, liver, kidneys, or blood.
- •Subjects were treated with radio or chemotherapy previously. A minimum of 2 to 3 months recovery time is required before treating with this investigational drug.
- •Subject is diagnosed as intratracheal lesions with metastasized pulmonary cancer not suitable for surgery, or refuses to be operated.
- •Subject should show lobular atelectasis with either complete or incomplete obstruction of the bronchi.
- •Physical examinations should show no functional disorders of the heart, liver, kidneys, central nervous system, and blood.
- •Subject performance status to be classified from Grade 0 to Grade 3, who can tolerate the fiberoptic bronchoscopy treatments.
- •In-patient is preferred. When subject is in satisfactory conditions, the out Cpatient can also be enrolled in this trial.
- •Two to three months recovery time is required for the subject has just received radio or chemotherapy.
- •Emergency request, subjects with serious lobular atelectasis and almost complete obstruction of the bronchi.
- •With the aid of a tracheal intubation and the help of the respirator, PTS may be intraumorally injected into the obstructed lesion via fiberoptic bronchoscopy outside of the tube, alongside of the intubation.
排除标准
- •Pregnant women and children will not be used as test subjects.
- •Subjects with serious functional disorders of the heart, liver, kidneys, or blood will be excluded.
- •Subjects who do not want to participate in the trial will not be used as test subjects.
- •Subject does not agree to participate.
- •Subject performance status is Grade 4, and the one who does not want to tolerate the discomfort of the PTS treatments via fiberoptic bronchscopy.
研究组 & 干预措施
Para-toluenesulfonamide Injection (PTS)
Experimental
Investigational product
干预措施: Para-toluenesulfonamide Injection (PTS) (Drug)
结局指标
主要结局
Maximum tolerable dose
时间窗: 4 weeks post-treatment
Maximum tolerable dose
次要结局
未报告次要终点
研究者
研究点 (1)
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