A Phase II Study of Ixabepilone in Asian Subjects With Unresectable or Metastatic Gastric Cancer Previously Treated With Fluoropyrimidine-based Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Overall Response Rate (ORR) Based on Modified Response Evaluation Criteria in Solid Tumors (RECIST)
研究概览
简要总结
The purpose of this study was to determine whether ixabepilone is effective in the treatment of unresectable or metastatic gastric cancer in Asian participants.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed gastric carcinoma originating from the stomach or gastroesophageal junction
- •Must have unresectable or metastatic disease
- •Asian ethnicity
- •Must have failed prior fluoropyrimidine-based chemotherapy
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- •measurable disease by with Response Evaluation Criteria in Solid Tumors (RECIST) guidelines
排除标准
- •>1 prior chemotherapy regimen in the metastatic setting or >2 prior chemotherapy if subject also received adjuvant therapy
- •Receipt of prior ixabepilone
- •Known brain or meningeal metastasis
- •Known viral hepatitis
- •Prior taxane therapy
- •Uncontrolled non-cancer related medical condition
- •Second malignancy
- •Peripheral neuropathy ≥ grade 2
- •Inadequate hematologic, renal and hepatic function
研究组 & 干预措施
Ixabepilone
干预措施: Ixabepilone (Drug)
结局指标
主要结局
Percentage of Participants With Overall Response Rate (ORR) Based on Modified Response Evaluation Criteria in Solid Tumors (RECIST)
时间窗: During treatment, assessed every 6 weeks (± 1 week) starting from the 1st dose of therapy until disease progression, or development of intolerable toxicity, for a maximum of 8 cycles (maximum time that any participant was on therapy was 30 weeks)
Percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) according to modified RECIST, as determined by investigator. CR: Disappearance of all evidence of target and non-target lesions. In case of lymph node, the lesions short axis of all nodes measuring \<10 mm. PR: At least 30% reduction from baseline in the sum of the longest diameter (LD) of all target lesions. CR and PR criteria should be met again after 4 weeks and before 6 weeks after initial assessment. A 2-sided confidence interval (CI) was computed using Clopper-Pearson method.
次要结局
- Percentage of Participants With Disease Control Rate(During treatment, assessed every 6 weeks (± 1 week) starting from the 1st dose of therapy until disease progression, or development of intolerable toxicity, for a maximum of 8 cycles (maximum time that any participant was on therapy was 30 weeks))
- Duration of Response(From the date of first PR or CR assessment to the date of progression, death, or last tumor assessment (maximum: 4.1 months))
- Progression Free Survival (PFS)(From the date of initiation of study therapy to the date of progression (up to 8.1 months).)
- Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs), and AEs Leading to Discontinuation of Study Therapy Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0(Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on ixapebilone therapy was 10.5 weeks (range: 3 to 30 weeks))
- Time to Response(Assessed every 6 weeks (± 1 week) starting from the first dose of study therapy until CR or PR (up to 12.1 weeks.))
- Number of Participants With Hematology Abnormalities(Assessed once every week for first 3 weeks, as clinically indicated, start of each 3 week cycle (maximum time that any participant was on therapy was 30 weeks).)
- Number of Participants With Serum Chemistry Abnormalities(Assessed within 2 weeks of first dose and every 3 weeks before therapy dose (maximum time that any participant was on therapy was 30 weeks).)