NCT02739529Unknown1 期
Dose-dense Paclitaxel (Genexol®-PM) Once a Week in Combination With Carboplatin Every 3 Weeks for Gynecologic Cancer (Adult Solid Tumor): a Phase I Trial
Samyang Biopharmaceuticals Corporation1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2016年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- The recommended dose for the phase II study
研究概览
简要总结
Dose-dense paclitaxel (Genexol®-PM) once a week in combination with carboplatin every 3 weeks for gynecologic cancer (adult solid tumor): a phase I trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 79 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients who aged 20 years or older and under 80 year old female
- •Patients who were diagnosed histologically or cytologically or who were scheduled to reccur as an gynecologic cancer (epithelial ovarian cancer , fallopian tube cancer, primary peritoneal cancer, cervical cancer, uterine corpus cance, etc)
- •Patients seemed appropriate for Paclitaxel and Carboplatin combination therapy for the treatment
- •Patients whose ECOG performance score are 0-2
- •Patients who have adequate blood, kidney and liver function on screening within 14 days before the administration of the test drugs
- •Hb ≥ 10g/dl: Patients with less than 10g/dl of hemoglobin level were not allowed to use the test drugs unless they were recovered to 10g/dl or more.
- •ANC ≥ 1500/mm3
- •Platelet Count ≥ 100,000/mm3
- •Serum AST and ALT ≤ 2.5 X ULN
- •Serum ALP ≤ 2.5 X ULN
- •Serum creatinine ≤ 2.5 X ULN
- •Patients who participated voluntarily and who provided written informed consent before participating in the study
排除标准
- •Patients with the history of carcinoma in the past 5 years other than gynecologic cancer
- •Patients who received radiotherapy at abdominal cavity or pelvis
- •Patients who were receiving immunotherapy or hormone therapy
- •Patients who received a major surgery other than debulking surgery within 2 weeks before the screening
- •Patients with a past or present medical history of metastasis in central nervous system (CNS)
- •Patients with NCI CTCAE V4.0 Grade 1 or more sensory or motor neuropathy
- •Patients with severe comorbidities as follows
- •medical or mental condition impossible to understand the clinical trial and provide a written informed consent, based on the investigators' decision
- •severe cardiovascular disease (such as ischemic heart disease requiring medical therapy, myocardial infarction within the last 6 months, and grade 2~4 congestive heart failure defined by New York Heart Association criteria)
- •uncontrolled active infectious disease
- •hypersensitivity to the test drugs or the vehicle
- •Patients who participated in another study within 4 weeks before the screening
- •Pregnant, lactating women or Patients who do not use contraceptive methods that can be medically accepted to the possibility of pregnancy in female volunteers
研究组 & 干预措施
Cohort 1
Experimental
Genexol-PM 100mg/m2 IV infusion D1,D8,D15 Carboplatin 5 AUC IV infusion D1
干预措施: Genexol-PM (Drug)
Cohort 2
Experimental
Genexol-PM 120mg/m2 IV infusion D1,D8,D15 Carboplatin 5 AUC IV infusion D1
干预措施: Genexol-PM (Drug)
Cohort 3
Experimental
Genexol-PM 120mg/m2 IV infusion D1,D8,D15 Carboplatin 6 AUC IV infusion D1
干预措施: Genexol-PM (Drug)
结局指标
主要结局
The recommended dose for the phase II study
时间窗: 2 years
Determined as the recommended dose for a phase 2 study based on the adverse events and toxicities at each dose groups
The maximum tolerated dose (MTD)
时间窗: 2 years
MTD was determined as the dose where more than 2 out of 6 subjects experienced DLT
次要结局
- Toxicities(2 years)
- The dose limiting toxicity (DLT)(2 years)
研究者
研究点 (1)
Loading locations...
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