NCT00877253已完成1 期
Open-label, Multicenter, Phase I Trial to Evaluate Efficacy and Safety of the Combination Therapy of Genexol®-PM Plus Carboplatin as a Firstline Treatment in Subjects With Advanced Ovarian Cancer
Samyang Biopharmaceuticals Corporation0 个研究点目标入组 18 人开始时间: 2008年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 主要终点
- Determine the MTD and recommended phase II dose of the combination therapy with Genexol-PM and Carboplatin in subjects with advanced ovarian cancer.
研究概览
简要总结
The purpose of this study is to determine the maximum tolerated dose of Genexol®-PM plus Carboplatin and evaluate the efficacy and safety of Genexol®-PM plus Carboplatin regimen in subjects with advanced ovarian cancer.
详细描述
This is a phase I trial to determine the maximum tolerated dose and recommended phase II dose of the combination therapy with Genexol®-PM and Carboplatin and to evaluate the efficacy and safety of Genexol®-PM when administered with Carboplatin in subjects with advanced ovarian cancer after debulking surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women ≥ 18 years old.
- •Signed informed consent before inclusion.
- •Subjects who have histologically or cytologically confirmed advanced epithelial ovarian cancer.(FIGO IIIB-IV)
- •Subjects who have measurable disease by RECIST after debulking surgery.
- •ECOG performance status of 0, 1, or
- •Estimated life expectancy of more than 6 months
- •Subjects who have the clinically acceptable function of blood, kidney and liver at screening visit
- •Hb ≥ 10g/dl
- •ANC ≥ 1.5×10^9/L
- •Platelet Count ≥ 100×10^9/L
- •Serum total bilirubin ≤ 1.5×ULN
- •Serum AST and ALT ≤ 2.5×ULN
- •Serum ALP ≤ 2.5×ULN
- •Serum creatinine ≤ 1.5×ULN
排除标准
- •Subjects who have received chemotherapy for ovarian cancer other than debulking surgery.
- •Subjects who have a history of radiotherapy to pelvis or abdominal cavity
- •Subjects who receive immunotherapy or hormonal therapy for ovarian cancer
- •Subjects who have other malignancies within the past 5 years
- •Subjects who have had a major surgery other than debulking surgery within 2 weeks prior to the screening/baseline visit
- •Subjects who have a history of metastasis or currently have a metastasis to the central nervous system(CNS)
- •Subjects who have a preexisting sensory or motor neuropathy of grade ≥ 1 based on NCI CTCAE V3.0
- •Subjects who have serious medical condition
- •Uncontrolled or severe cardiovascular disease(Ischemic heart disease, myocardial infarction within the last 6 months, congestive heart failure)
- •Uncontrollable infection
- •Previous allergic reactions in connection with paclitaxel and carboplatin
- •Subjects who participate another clinical trial within the last 4 weeks before inclusion
研究组 & 干预措施
Dose Level One
Experimental
干预措施: Genexol-PM 220mg/㎡, Carboplatin 5AUC (Drug)
Dose Level Two
Experimental
干预措施: Genexol-PM 260mg/㎡, Carboplatin 5AUC (Drug)
Dose Level Three
Experimental
干预措施: Genexol-PM 300mg/㎡, Carboplatin 5AUC (Drug)
结局指标
主要结局
Determine the MTD and recommended phase II dose of the combination therapy with Genexol-PM and Carboplatin in subjects with advanced ovarian cancer.
时间窗: until either MTD is achieved or maximum planned dose is tested
次要结局
- Objective Response Rate (Complete Response (CR) + Partial Response (PR))(about 1 year (until end of trial))
- Time to Tumor Progression(about 1 year (until end of trial))
- Overall Survival(about 1 year (until end of trial))
- Safety profiles(about 1 year (till end of trial))
研究者
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