NCT03453034Unknown1 期
To Study the Pharmacokinetic Characteristics of TQ-B233 in the Human Body, Recommend a Reasonable Regimen for Subsequent Research
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
- Area under the plasma concentration versus time curve (AUC)
研究概览
简要总结
Study of Tolerance and Pharmacokinetics of TQ-B3233 Capsule, phase I,single arm.
详细描述
The maximum tolerated dose (MTD) of TQ-B3233 [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]The highest dose at which no more than 33% of the subjects experience a dose-limiting toxicity (DLT) during treatment.
Pharmacokinetics of TQ-B3233 (in whole blood):In the study of single-dose, full PK profiles will be obtained at H0/H0.5/H1/H2/H3/H5/H8/H10/H12/H24/H48/H72（H means Hour）.In the study of multiple-dose,full PK profiles will be obtained at D0/D1/D2/D8/D15/D22/D28（D means Day）.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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 definitely diagnosed by pathology and/or cytology as BRAF mutation advanced malignant melanoma.
- •18-70 years old, ECOG PS:0-1,Life expectancy of more than 3 months;
- •Patients treated with chemotherapy agents or surgery before being enrolled into the study need waiting for 4 weeks, 6 weeks will be needed if agents were nitrocarbamide and mitomycin C;
- •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 consent 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 had previously received specific BRAF inhibitors;
- •A variety of factors that affect oral medication (such as inability to swallow, gastrointestinal resection, chronic diarrhea, intestinal obstruction, etc.)
- •Patients who participated in other anticancer drug clinical trials within 4 weeks ;
- •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 non-healing wounds or fractures;
- •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;
- •Coagulation function abnormality: haemorrhagic tendencies (e.g. active digestive tract ulcer), or are receiving thrombolytic or anticoagulant therapy;
- •Patients with immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or organ transplant history;
- •Patients with thyroid dysfunction;
- •Patients with concomitant diseases which could seriously endanger themselves or those who won't complete the study according to investigators;
- •Parents with hepatitis b surface antigen positive or HCV;
研究组 & 干预措施
TQ-B3233 capsule
Experimental
QD or BID; patients are given the doses according to the protocal, and a cycle is 28 days.
干预措施: TQ-B3233 (Drug)
结局指标
主要结局
Area under the plasma concentration versus time curve (AUC)
时间窗: up to 28 Days
Peak time(Tmax)
时间窗: up to 28 Days
Half life(t1/2)
时间窗: up to 28 Days
maximum tolerated dose(MTD)
时间窗: 28 Days
dose-limiting toxicity(DLT)
时间窗: 28 Days
Peak Plasma Concentration(Cmax)
时间窗: up to 28 Days
次要结局
- Objective Response Rate (ORR)(up to 24 months)
研究者
研究点 (1)
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