NCT05052437已完成1 期
Open, Multicenter, Phase Ic Clinical Study on the Pharmacokinetics and Drug Interactions of Utidelone Plus Capecitabine in Patients With Recurrent and Metastatic Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Peak Plasma Concentration (Cmax)
研究概览
简要总结
This trial is an open, multi-center, phase Ic clinical study on the pharmacokinetics and drug interactions of utidelone injection combined with capecitabine in patients with recurrent and metastatic breast cancer.
The purpose of this trial is:
- To evaluate the pharmacokinetic characteristics of continuous intravenous administration of utidelone.
- To evaluate the drug interaction of utidelone and capecitabine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Voluntarily sign an informed consent form, have good compliance, and cooperate with relevant inspections.
- •Histologically and/or cytologically diagnosed patients with advanced, metastatic breast cancer.
- •Patients who have previously received at least one anthracycline and taxane drug therapy (neoadjuvant therapy, adjuvant therapy, or recurrence and metastasis therapy), or the investigator believes that they can be included in this study.
- •Age ≥18 years; physical condition score ECOG 0~2 points.
- •Within 4 weeks before enrollment, Neuropathy should be less than grade 2 (NCI CTCAE 5.0).
- •Within 1 week before enrollment, routine blood examinations were basically normal (based on the normal value of each research center laboratory):
- •White blood cell count (WBC) ≥3.0×109/L;
- •Neutrophil count (ANC) ≥ 1.5×109/L;
- •Platelet count (PLT) ≥100×109/L.
- •Hemoglobin ≥9g/dL.
- •Within 1 week before enrollment, liver and kidney function tests were basically normal (the normal value of each research center laboratory is standard):
- •Total bilirubin (TBIL)≤1.5×upper limit of normal (ULN);
- •Alanine aminotransferase (SGPT/ALT)≤2.5×ULN (for liver metastases≤5×ULN);
- •Aspartate aminotransferase (SGOT/AST)≤2.5×ULN (for liver metastases≤5×ULN);
- •Creatinine clearance rate (Ccr) ≥60 ml/min.
- •No major organ dysfunction.
- •The patient must agree to provide blood, urine and stool samples for pharmacokinetic studies, and collect them in strict accordance with the required time points and intervals.
- •No mental abnormality, able to understand and undertake informed consent.
排除标准
- •Those who need to receive non-investigative anti-cancer therapy (such as chemotherapy, immunotherapy or biological therapy) during the administration period of this trial.
- •People who are severely allergic to castor oil, or who have had serious adverse reactions to anti-microtubule drugs in the past.
- •Within 4 weeks before receiving treatment, have had any major surgery or suffered major trauma; or are expected to undergo major surgery during the treatment.
- •Pregnancy (positive pregnancy test), breastfeeding patients, or those who are unwilling to use contraception during the test;
- •Those with uncontrollable intracranial hypertension syndrome (persistent headache, short-term blurred vision, and/or diplopia)
- •Combined serious diseases, including severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled high blood pressure, severe infection, active peptic ulcer, etc.
- •Known HIV infection, or untreated active hepatitis B or C;
- •Known to have alcohol or drug addiction, or have a history of uncontrollable mental illness, lack of legal capacity or limited legal capacity;
- •The investigator believes that it is inappropriate to participate in this trial.
- •Participate in another clinical trial or use other research treatments at the same time.
研究组 & 干预措施
Utidelone
Experimental
干预措施: Utidelone (Drug)
Utidelone plus capecitabine
Experimental
干预措施: Utidelone Injection; capecitabine (Drug)
结局指标
主要结局
Peak Plasma Concentration (Cmax)
时间窗: 12 weeks
To measure the maximal plasma concentration of the study drugs and evaluate the pharmacokinetic characteristics of continuous intravenous administration of utidelone, measure PK parameters such as Maximum Plasma Concentration \[Cmax\]
Area under the plasma concentration versus time curve (AUC)
时间窗: 12 weeks
To get area under the plasma concentration versus time curve
C-T curve
时间窗: 12 weeks
To evaluate the pharmacokinetic interaction of utidelone and capecitabine in patients when administered in combination.
次要结局
- Measure and plot r-t curve(12 weeks)
- Incidence of treatment-related adverse events as assessed by CTCAE v4.0(6 months)
研究者
研究点 (2)
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