Phase II, Open Label Study of Ispinesib in Subjects With Advanced or Metastatic Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Overall Response Rate (ORR) Following Administration of Ispinesib
研究概览
简要总结
The purpose of this research study is to find how breast cancer responds to the investigational drug, Ispinesib. An investigational drug is a drug that has not been approved by the Food and Drug Administration (FDA) and is available for research use only. In particular, this study will try is to find the answers to the following research questions:
- Does breast cancer respond to Ispinesib?
- What are the side effects of Ispinesib?
- How much Ispinesib is in the blood at specific times after it is taken?
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
- •Stage IIIB or Stage IV breast cancer
- •Previously received anthracycline and taxane therapy
- •Exclusion criteria:
- •Actively receiving anti-cancer therapy agent(s).
排除标准
- 未提供
研究组 & 干预措施
SB-715992
Females with advanced or metastatic breast cancer were administered Ispinesib
干预措施: Ispinesib (Drug)
结局指标
主要结局
Percentage of Participants With Overall Response Rate (ORR) Following Administration of Ispinesib
时间窗: After cycle 2 and repeated every 2 cycles up to Cycle 10, up to 26 months
Overall tumor response rate, was defined as the percentage of participants achieving either a complete response (CR) or partial response (PR), stable disease (SD), or progressive disease (PD). It was assessed by Computer tomography (CT) or Magnetic Resonance Imaging (MRI) scan. Response and progression was evaluated in this study using the Response Evaluation Criteria in Solid Tumors (RECIST) 1.0. The target lesions (TLs): CR, Disappearance of all TLs; PR where at least a 30% decrease in the sum of the longest diameter (LD) of TLs, taking as reference the baseline sum LD; PD : At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
次要结局
- Median Time to Response(After cycle 2 and repeated every 2 cycles up to Cycle 10, up to 26 months)
- Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)(From first dose of study drug (Day 1) to 30 days after the last dose (up to 26 months))
- Number of Participants With Toxicity Shift Grade From Baseline for Hematology Parameters(After cycle 2 and repeated every 2 cycles up to Cycle 10, up to 26 months)
- Pharmacokinetic (PK) Parameter-Clearance(Pre-dose, and post-dose 30 minute to 1 hour, 1.5 to 2.5 hours, 4 to 6 hours and 20 to 24 hours up to Cycle 10, up to 26 months)
- Median Time-to-progression After Administration of Inspinesib(After cycle 2 and repeated every 2 cycles up to Cycle 10, up to 26 months)
- Duration of Response(After cycle 2 and repeated every 2 cycles up to Cycle 10, up to 26 months)
- Number of Participants With Clinical Concern Values for Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Temperature and Heart Rate(After cycle 2 and repeated every 2 cycles up to Cycle 10, up to 26 months)
- Number of Participants With Toxicity Shift Grade From Baseline for Clinical Chemistry Grade Shifts(After cycle 2 and repeated every 2 cycles up to Cycle 10, up to 26 months)
- PK Parameter-Volume of Distribution(Pre-dose, and post-dose 30 minute to 1 hour, 1.5 to 2.5 hours, 4 to 6 hours and 20 to 24 hours up to Cycle 10, up to 26 months)