NCT00291837已完成2 期
Phase II Open Label Study of CT-2106 as a Single Agent in Patients With Advanced Metastatic Ovarian Cancer Who Have Failed One Prior Platinum and Taxane Based Regimen
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 7
- 主要终点
- response rate
研究概览
简要总结
The purpose of this sudy is to determine the response rate of CT-2106 in patients with advanced ovarian cancer who have failed one prior platinum and taxane based regimen.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with advanced ovarian carcinoma, who have failed one prior platinum and taxane containing regimen
- •Only one prior chemotherapy containing either cisplatin or carboplatin plus taxanes administered concomitantly
- •At least one measurable lesion according to RECIST
- •ECOG performance status 0 or 1
- •at least 18 years old
- •Adequate haematological function
- •Adequate renal and hepatic functions
- •Normal coagulation parameters
排除标准
- •Platinum-sensitive patients (Group 2) who responded (CR or PR) to a 1st line therapy and subsequently progressed or relapsed after a treatment-free interval of > 12 months
- •Pregnant or lactating patients
- •Prior treatment with camptothecins
- •Presence or history of CNS metastasis or carcinomatous leptomeningitis;
- •Current active infection per investigator assessment;
- •Unresolved bowel obstruction or subobstruction, uncontrolled Crohn's disease or ulcerative colitis;
- •Current history of chronic diarrhea >= grade 1 (CTCAE version 3);
- •Surgery or radiotherapy ≤ 4 weeks before first study treatment. In case of cytoreductive surgery for the progression of the disease, ≤ 2 weeks before the 1st study treatment are allowed;
- •Other uncontrolled, serious illness or medical condition, as determined by the investigator;
- •Concomitant (or within 4 weeks before inclusion) administration of any other experimental drug under investigation;
- •Concurrent treatment with any other anti-cancer therapy;
- •Known HIV positivity or AIDS-related illness;
- •Patients who cannot be regularly followed up for psychological, social, familial or geographic reasons.
结局指标
主要结局
response rate
次要结局
- toxicity
- response duration
- time to progression
- survival
研究者
研究点 (7)
Loading locations...
相似试验
撤回
2 期
Safety and Effectiveness Study of CPI-613 to Treat Refractory or Relapsed Leukemia and Myelodysplastic SyndromeAcute Myeloid Leukemia (AML)Myelodysplastic Syndrome (MDS)NCT01520805Cornerstone Pharmaceuticals
终止
2 期
Phase 2 Safety, Tolerability and Efficacy Study of CPI-613 in Cancer PatientsCancerNCT01832857Cornerstone Pharmaceuticals7
终止
2 期
Phase IIa Study of Copanlisib in Relapsed or Refractory Mantle Cell Lymphoma (MCL)Lymphoma, Mantle-CellNCT02455297Bayer4
终止
2 期
A Study to Learn About the Study Medicine (Called Ontorpacept or TTI-621) Given Alone and in Combination With Doxorubicin in People With LeiomyosarcomaLeiomyosarcomaNCT04996004Pfizer76
进行中（未招募）
1 期
Combination of Pembrolizumab With TGR-1202 in Patients With Relapsed/Refractory CLL and B-cell NHLB-cell Non Hodgkin LymphomaCLLNCT03283137University of Chicago20