A Randomized Phase 2 Study of LY2523355 Versus Ixabepilone in Patients With Metastatic or Locally Recurrent Breast Cancer Who Have Received Prior Taxane Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Change in Tumor Size (CTS) From Baseline to the End of Cycle 2
研究概览
简要总结
The purpose of the study is to evaluate the anti-tumor activity of LY2523355 relative to ixabepilone for the treatment of metastatic or locally recurrent breast cancer using change in tumor size as a continuous measure of response.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Have histologic or cytologic diagnosis of metastatic or locally recurrent breast cancer that is not amenable to therapy given with curative intent.
- •Have measurable disease defined by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 guidelines.
- •Have received 2 or more prior standard cytotoxic chemotherapy regimens for metastatic breast cancer and be, in the opinion of the investigator, an appropriate candidate for experimental therapy. Regimens received in the neoadjuvant or adjuvant setting are not counted as prior regimens.
- •Have received a prior taxane in the neoadjuvant, adjuvant, or metastatic setting.
- •Have recovered from the acute effects of prior chemotherapy, hormonal therapy, and radiation prior to study enrollment.
- •Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale.
- •Have adequate organ function.
排除标准
- •Have Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or greater (moderate or worse) peripheral neuropathy
- •Have a second primary malignancy.
- •Have symptomatic, untreated, or uncontrolled central nervous system metastases.
- •Have received autologous stem cell transplant following high-dose chemotherapy.
- •Have serious preexisting medical conditions that in the opinion of the investigator would preclude participation in this study.
- •Have active symptomatic fungal, bacterial, and/or known viral infection including active human immunodeficiency virus (HIV) or viral hepatitis.
- •Have previously received LY2523355 in another study investigating this agent or therapy with ixabepilone or an ixabepilone-containing regimen.
- •Have a history of radiation therapy involving more than 25 percent of the bone marrow.
- •Have a Fridericia corrected QT (QTcF) interval of >470 milliseconds (msec) on screening electrocardiogram (ECG).
- •Have QRS widening of >120 msec on screening ECG.
- •Cannot change or stop taking a strong Cytochrome P450 3A4 (CYP3A4) inhibitor or CYP3A4 inducer per the ixabepilone label.
- •Have hypersensitivity to drugs formulated with Cremophor® EL per the ixabepilone label.
研究组 & 干预措施
LY2523355 + pegfilgrastim or filgrastim
LY2523355: Five milligrams per meter squared per day (mg/m^2/day) (dosage determined by calculating participant's body surface area) administered intravenously as a 1-hour infusion on Days 1, 2, and 3 of a 21-day Cycle for 2 Cycles. Pegfilgrastim or Filgrastim: Dosage is determined by standard of care and is administered intravenously on Day 4 of 21-day Cycle for 2 Cycles. If at the end of 2 Cycles the participant was receiving benefit, the participant may have remained on study drug for additional cycles until a criterion for study discontinuation was met.
干预措施: LY2523355 (Drug)
LY2523355 + pegfilgrastim or filgrastim
LY2523355: Five milligrams per meter squared per day (mg/m^2/day) (dosage determined by calculating participant's body surface area) administered intravenously as a 1-hour infusion on Days 1, 2, and 3 of a 21-day Cycle for 2 Cycles. Pegfilgrastim or Filgrastim: Dosage is determined by standard of care and is administered intravenously on Day 4 of 21-day Cycle for 2 Cycles. If at the end of 2 Cycles the participant was receiving benefit, the participant may have remained on study drug for additional cycles until a criterion for study discontinuation was met.
干预措施: pegfilgrastim (Drug)
LY2523355 + pegfilgrastim or filgrastim
LY2523355: Five milligrams per meter squared per day (mg/m^2/day) (dosage determined by calculating participant's body surface area) administered intravenously as a 1-hour infusion on Days 1, 2, and 3 of a 21-day Cycle for 2 Cycles. Pegfilgrastim or Filgrastim: Dosage is determined by standard of care and is administered intravenously on Day 4 of 21-day Cycle for 2 Cycles. If at the end of 2 Cycles the participant was receiving benefit, the participant may have remained on study drug for additional cycles until a criterion for study discontinuation was met.
干预措施: filgrastim (Drug)
ixabepilone
Forty milligrams per meter squared per day (mg/m^2/day) (dosage determined by calculating participant's body surface area) administered intravenously as a 3-hour infusion on Day 1 of a 21-day Cycle for 2 Cycles. If at the end of 2 Cycles the participant was receiving benefit, the participant may have remained on study drug for additional cycles until a criterion for study discontinuation was met.
干预措施: ixabepilone (Drug)
结局指标
主要结局
Change in Tumor Size (CTS) From Baseline to the End of Cycle 2
时间窗: Baseline up to end of Cycle 2 (Day 42)
The log ratio of tumor size at Cycle 2 to tumor size at baseline is calculated for each participant, where the tumor size is the sum of the target lesion measurements at each assessment.
次要结局
- Pharmacokinetics, Maximum Plasma Concentration (Cmax) of LY2523355(Cycle 1: Day 1 and Day 3)
- Pharmacokinetics, Intracycle Accumulation Ration (Ra) of LY2523355(Cycle 1: Day 1 and Day 3)
- Progression-free Survival (PFS)(Baseline to measured progressive disease or date of death from any cause (up to 423 days))
- Percentage of Participants Achieving a Clinical Benefit (Clinical Benefit Rate)(Baseline to measured progressive disease or date of death from any cause (up to 423 days))
- Pharmacokinetics, Maximum Plasma Concentration (Cmax) of LSN2546307(Cycle 1: Day 1 and Day 3)
- Percentage of Participants Achieving an Overall Response (Overall Response Rate)(Baseline to measured progressive disease or date of death from any cause (up to 423 days))