NCT00753740撤回2 期
A Phase II Multi-Center Randomized, Double-Blind, Placebo-Controlled Study of Maintenance IT-101 in Platinum Sensitive Ovarian Cancer Patients Who Received 4-6 Cycles of a 2nd Line Platinum-Based Regimen Without Disease Progression.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 7
- 主要终点
- To Compare the proportion of patients without evidence of disease progression at 30 weeks following randomization between IT-101 at 12 mg/m2/dose or 15 mg/m2/dose to a placebo infusion treatment administered every other week.
研究概览
简要总结
This study will assess the effect of IT-101 on delaying cancer progression in patients with platinum sensitive ovarian cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 78 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women between the age of 18 and 78, inclusive;
- •Evidence of platinum-sensitive ovarian cancer following the patient's primary treatment(>= 6 months);
- •Received a 2nd line platinum-based chemotherapy regimen (4-6 cycles) without evidence of progression;
- •May have measurable or unmeasurable disease;
- •Eastern Cooperative Oncology Group (ECOG) 0 or 1;
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Women who are pregnant or lactating;
- •Prior treatment with a topoisomerase inhibitor;
- •Patients with unacceptable organ and/or hematologic reserve at screening;
- •Urine protein of > 500 mg/day or active nephropathy;
- •Electrocardiogram (ECG) with evidence of clinically significant conduction abnormalities or active ischemia as determined by the investigator;
- •History of pancreatitis within the last 12 months;
- •Patients treated with previous high dose chemotherapy or stem cell transplant within the last 5 years;
- •Use of any investigational agents within 4 weeks of study enrollment;
- •Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, psychiatric illness or other co-morbidity that presents a risk to the patient as determined by the investigator.
研究组 & 干预措施
12mg/m2/dose
Experimental
12mg per meter squared per dose
干预措施: IT-101 (12mg/m2/dose) (Drug)
15mg/m2/dose
Experimental
15mg per meter squared per dose
干预措施: IT-101 (15mg/m2/dose) (Drug)
Placebo
Placebo Comparator
5% dextrose infusion (placebo)
干预措施: 5% Dextrose (Placebo) (Drug)
结局指标
主要结局
To Compare the proportion of patients without evidence of disease progression at 30 weeks following randomization between IT-101 at 12 mg/m2/dose or 15 mg/m2/dose to a placebo infusion treatment administered every other week.
时间窗: 30 weeks
次要结局
- Comparison of adverse drug experiences between each treatment(30 weeks)
- Compare the frequency of drug-related toxicities between each treatment arm(30 weeks)
- Compare Quality of Life (QOL, patient-reported) measures (FACT-O, FOSI) between treatment arms.(30 weeks)
研究者
研究点 (7)
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