NCT00593827已完成2 期
Phase II Randomized Trial of Weekly and Every 3-week Ixabepilone in Metastatic Breast Cancer (MBC) Patients
R-Pharm51 个研究点 分布在 1 个国家目标入组 176 人开始时间: 2008年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 176
- 试验地点
- 51
- 主要终点
- Progression-Free Survival (PFS) at 6 Months (6-month PFS Rate): Proportion of Participants Progression Free at 6 Months
研究概览
简要总结
The purpose of this study was to determine the effects of the weekly regimen of ixabepilone dosing compared to the once every 3 week dosing regimen in participants with metastatic breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Has MBC that is measurable by RECIST or has nonmeasurable disease with serum CA27.29 (or CA15.3) ≥ 50
- •Has Human Epidermal Growth Factor Receptor 2 (HER2) negative breast cancer
- •Prior chemotherapy is permitted with no limit on the number of prior regimens
- •Two weeks or more have elapsed since last chemotherapy or radiation treatment
- •Has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-2
- •Is female, ≥ 18 yrs of age
- •Protocol defined appropriate laboratory values
- •Negative pregnancy test within 7 calendar days prior to registration
- •Has signed a patient informed consent
排除标准
- •Had prior treatment with ixabepilone or other epothilones
- •Has HER2+ disease
- •Has a known, prior, severe (National Cancer Institute Common Terminology Criteria Adverse Events [NCI CTCAE] Grade 3-4) history of hypersensitivity reaction to a drug formulated in Cremophor ® EL (polyoxyethylated castor oil)
- •Is receiving concurrent immunotherapy, hormonal therapy or radiation therapy
- •Is receiving concurrent investigational therapy or has received such therapy within the past 30 days
- •Has peripheral neuropathy > Grade 1
- •Has evidence of central nervous system (CNS) involvement requiring radiation or steroid treatment. Participants with stable brain metastases who are off steroids at least 2 weeks are eligible
- •Is pregnant or breast feeding
研究组 & 干预措施
Arm 1
Active Comparator
ixabepilone 16 mg/m^2 weekly for 3 weeks followed by 1 week rest
干预措施: Ixabepilone (Drug)
Arm 2
Active Comparator
ixabepilone 40 mg/m^2 every 3 weeks
干预措施: Ixabepilone (Drug)
结局指标
主要结局
Progression-Free Survival (PFS) at 6 Months (6-month PFS Rate): Proportion of Participants Progression Free at 6 Months
时间窗: From the date of randomization to 6-months on study
PFS at 6 months was defined as proportion of participants who neither progressed nor died before 6 months. Computed using Kaplan-Meier estimates.
次要结局
- Best Response as Assessed With RECIST(Assessed at 12-week intervals until disease progression (to a maximum follow-up for tumor response of 26.3 months))
- Time to Response(From the date of first dose to date of first PR or CR assessment ( maximum participant time to response of 8.3 months))
- Incidence of All Grades of Peripheral Neuropathy(Assessed from the date of first study dose until at least 30 days after the last dose of study drug. Median time on study therapy was 12 weeks (range: 4-60 weeks for 16 mg/m^2 arm; 3-87 weeks for 40 mg/m^2 arm).)
- Duration of Response(From the date of first PR or CR assessment to date of progression, death, or last tumor assessment (maximum participant duration of response of 17.4 months))
- Median Progression Free Survival(From the date of randomization to date of progression, death, or last tumor assessment (maximum participant PFS of 25.7 months))
- Overall Response Rate (ORR) Based on Response Criteria in Solid Tumors [RECIST](Assessed at 12-week intervals until disease progression (to a maximum follow-up for tumor response of 26.3 months))
- Overall Survival (OS)(From the date of randomization to date of death (maximum participant OS of 26.3 months))
研究者
研究点 (51)
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