A Phase 2 Open-Label, Multicenter Study of SNS-595 Injection in Patients With Platinum-Resistant Ovarian Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 183
- 试验地点
- 20
- 主要终点
- Overall Response Rate (CR+PR) Per Investigator Assessment Based on GOG-RECIST Criteria
研究概览
简要总结
The purpose of this study is to evaluate the objective response rate, safety and identify potential biomarkers in platinum-resistant ovarian cancer patients treated with voreloxin injection given on a 28-day cycle.
详细描述
Other objectives of this study are to evaluate Progression-free survival and measure CA-125 response rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Histologically or cytologically documented epithelial ovarian cancer, primary peritoneal carcinoma, or fallopian tube cancer
- •Completed at least one Platinum Based Therapy (PBT) regimen (carboplatin, cisplatin, or another organoplatinum compound).
- •Evidence of platinum-resistant disease, relapse/progression within 6 months of the completion of PBT, or intolerant to PBT (inability to receive PBT due to hypersensitivity reactions to platinum)
- •Patients with primary platinum-resistant disease are allowed to receive no more than one nonplatinum cytotoxic regimen and no more than one noncytotoxic regimen for the management of recurrent or persistent disease after the development of primary platinum-resistance.
- •Measurable disease per GOG-RECIST criteria
- •GOG Performance Status of 0 or 1
排除标准
- •Radiotherapy, chemotherapy, and hormonal, cytokine, or targeted therapy, within 3 weeks (nitrosurea or mitomycin C within 6 weeks) prior to the anticipated first day of treatment.
- •Monoclonal antibody therapy within 4 weeks prior to clinical study entry
- •Unresolved or impending bowel obstruction
- •Other active malignancies or other malignancies within the last 12 months except nonmelanoma skin cancer or cervical intraepithelial neoplasia
- •Prior radiotherapy to more than 25% of the marrow space
- •Requiring hemodialysis or peritoneal dialysis
- •Myocardial infarction or cerebrovascular accident/transient ischemic attack within the 6 months prior to the anticipated first day of treatment
- •Thromboembolic event (deep vein thrombosis [DVT] or pulmonary embolus [PE]) within 28 days prior to the anticipated first day of treatment
- •History of active CNS metastases
- •Any other medical, psychological, or social condition that would contraindicate the patient's participation in the clinical study due to safety or compliance with clinical study procedures.
- •Please note: There are additional inclusion/exclusion criteria for this study. Please contact the study center for additional information and to determine if you meet all study criteria.
研究组 & 干预措施
All study patients
All patients will receive voreloxin injection
干预措施: Voreloxin Injection (Drug)
结局指标
主要结局
Overall Response Rate (CR+PR) Per Investigator Assessment Based on GOG-RECIST Criteria
时间窗: GOG-RECIST assessment obtained on cycle2, 4 and 6 Day 21for patients treated with 48 mg/m2 SNS-595 and Day 28 for patients treated with 60 mg/m2, through 28 (±14) days afte the last treatment at the end of safety follow up period
Response rate was calculated per investigator's tumor assessment based on GOG-RECIST, which includes radiographic imaging, physical examination results, and CA-125 levels. No independent review of CT scans (lesion assessments) was performed. CR: disappearance of all target and nontarget lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Normalization of CA125, if elevated at baseline, is required for ovarian carcinoma studies. PR is \>= 30% decrease in the sum of LD of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of nontarget lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required.
次要结局
- Progression-free Survival (PFS) Using Kaplan-Meier Methods(From the first teratment of Vosaroxin to the end of Cycle 6 or 28 days after the last treatment at the end of safety follow up period if continued in the extended treatment period)