NCT03447145Unknown1 期
Phase I Study of Tolerance and Pharmacokinetics of TQ-B3203
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Peak time（Tmax）
研究概览
简要总结
To identify the safety and tolerance of TQ-B3203.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients definitedly diagnosed by pathology and/or cytology as advanced solid tumor,those who lack of standard treatments or treatment failure;
- •Patients treated with chemotherapy agents or surgery before being enrolled into the study need waiting for 30 days, 6 weeks will be needed if agents were Nitrocarbamide and Mitomycin C
- •18-70 years old,Eastern Cooperative Oncology Group(ECOG):0-1,Life expectancy of more than 3 months,BMI:18.5-26;
- •Main organs function is normal;
- •Women of childbearing potential should agree to use and utilize an adequate method of contraception (such as intrauterine device，contraceptive and condom) throughout treatment and for at least 6 months after study is stopped；the result of serum or urine pregnancy test should be negative within 7 days prior to study enrollment，and the patients required to be non-lactating；Man participants should agree to use and utilize an adequate method of contraception throughout treatment and for at least 6 months after study is stopped;
- •Patients should be voluntary and sign the informed consents before taking part in the study;
排除标准
- •Patients with Malignant tumors within 5 years, except for non-melanoma skin cancer and in situ cancer;
- •Patients who participated in other anticancer drug clinical trials within 4 weeks;
- •Patients treated with Irinotecan,Topotecan and any other topoisomerase I inhibitors or related clinical trials;
- •Patients of double locus mutation of UGT1A1*6、UGT1A1*28;
- •Patients who cannot stop using inhibitors of CYP3A4 and UGT1A1 7 days before enrolled in the study,inducers of CYP3A4 need 2 weeks.
- •Patients who can not be injected and patients with interstitial pneumonia or radiation pneumonia;
- •Patients with pericardial effusion,pleural effusion or ascitic fluid, patients with 2nd respiratory syndrome or above are refused according to National Cancer Institute Common Terminology Criteria for Adverse Events(CTC AE);
- •Patients with brain metastasis, spinal cord compression, cancerous meningitis, CT or MRI examination reminds patients with cerebral or soft meningeal diseases in the screening phase;
- •Patients with drug abuse history or unable to get rid of drugs or Patients with mental disorders;
- •Patients with non-healing wounds or fractures;
- •Patients got radiotherapy for bone metastases 2 weeks before being enrolled in the study;
- •Patients with urine pro 2+ and the quantitative result>1.0g
- •Patients got Arteriovenous thrombosis 6 months before being the study "Blood pressure unable to be controlled ideally by one drug(systolic pressure≥150 mmHg，diastolic pressure≥90 mmHg);
- •Patients with Grade 1 or higher myocardial ischemia, myocardial infarction or malignant arrhythmias or cardiac insufficiency (including QTc≥480ms) and patients with Grade 3 or higher congestive heart failure (NYHA Classification);"
- •Patients with immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or organ transplant history;
- •Patients with thyroid dysfunction;
- •Patients diagnosed with glaucoma,or prostatomegaly need to be treated;
- •Coagulation function abnormality: haemorrhagic tendencies (e.g. active digestive tract ulcer), or are receiving thrombolytic or anticoagulant therapy
- •Patients with concomitant diseases which could seriously endanger themselves or those who won't complete the study according to investigators;
- •Patient with hepatitis b surface antigen positive(HBV DNA>1000) or hepatitis C virus(HCV);
研究组 & 干预措施
TQ-B3203
Experimental
干预措施: TQ-B3203 (Drug)
结局指标
主要结局
Peak time（Tmax）
时间窗: 21 days
Peak Plasma Concentration(Cmax)
时间窗: 21 days
The maximum tolerated dose(MTD)
时间窗: 21 days
dose-limiting toxicity(DLT)
时间窗: 21 days
Area under the plasma concentration versus time curve (AUC)
时间窗: 21 days
Half life（t1/2）
时间窗: 21 days
Clearance（CL）
时间窗: 21 days
次要结局
- Objective Response Rate(ORR)(each 42 days up to intolerance the toxicity or progression disease (up to 24 months))
研究者
研究点 (1)
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