A Phase 2, Single Arm Study of BSI-201 in Patients With BRCA-1 or BRCA-2 Associated Advanced Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 12
- 主要终点
- Best overall response
研究概览
简要总结
The goal of this study was to determine the efficacy of iniparib (BSI-201/SAR240550) in patients with breast cancer gene-associated (BRCA) ovarian cancer.
Up to 35 patients were to be treated using a Simon 2-stage optimal design, i.e. twelve were to be treated in a first stage, then if 2/12 patients responded to treatment as defined by Response Evaluation Criteria in Solid Tumor (RECIST), 23 additional patients were be treated in the second stage.
详细描述
Participants were treated for at least one 8-week cycle, with additional cycles as long as they had stable or responding disease (per RECIST criteria) and wished to remain on study.
Participants had a final follow-up visit within 4 weeks following the last dose of iniparib, after which time they were contacted by study staff every 3 months for the first year and every 6 months thereafter to assess disease status and survival.
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
- •Female, age 18 or older;
- •Histologically or cytologically confirmed advanced epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer (stage III or IV);
- •At least one previous regimen with platinum/taxane combination therapy and no curative options as determined by their physician (no limit on the number of prior therapies);
- •Confirmed BRCA1 or BRCA2 status;
- •One or more measurable lesions, at least 10mm in longest diameter by spiral computed tomography (CT) scan or 20mm in longest diameter when measured with conventional techniques (palpation, plain x-ray, CT or magnetic resonance imaging (MRI));
- •Karnofsky performance status ≥70%;
- •Estimated life expectancy of at least 16 weeks.
排除标准
- •Normal clinical laboratory values;
- •Any anti-cancer therapy within 21 days prior to study start;
- •Any other malignancy within 3 years of study start, except adequately treated carcinoma in situ of the cervix, ductal carcinoma in situ (DCIS) of the breast, or basal or squamous cell skin cancer;
- •Active viral infection including HIV/AIDS, Hepatitis B or Hepatitis C infection;
- •Active central nervous system or brain metastases;
- •History of seizures or current treatment with anti-epileptic medication;
- •Persistent grade 2 or greater toxicities from prior therapy, excluding alopecia.
研究组 & 干预措施
Iniparib
Iniparib, twice weekly on Days 1 and 4 of each week during 8-week cycles
干预措施: Iniparib (Drug)
结局指标
主要结局
Best overall response
时间窗: until treatment discontinuation (assessment at the at the end of each 8-week cycle)
Best overall response was defined as the best evaluation observed through the entire treatment period based on Response Evaluation Criteria in Solid Tumor (RECIST) criteria.
Objective response rate
时间窗: until treatment discontinuation (assessment at the at the end of each 8-week cycle)
Objective response rate was defined as the percentage of participants with confirmed partial response or complete response according to RECIST criteria.
次要结局
- Clinical benefit rate(until treatment discontinuation (assessment at the at the end of each 8-week cycle))
- Progression-Free Survival(until death or study end)
- Overall Survival(until death or study end)
- Cancer antigen 125 response (participants with elevated CA125)(until treatment discontinuation (assessment at the at the end of each 8-week cycle))