A Phase 1 Study of Ixabepilone Administered as 3 Oral Doses Each Separated by 6 Hours Every 21 Days in Subjects With Advanced Cancer
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Number of Participants With a Dose-Limiting Toxicity (DLT)
研究概览
简要总结
This Phase 1 study of oral ixabepilone given every 6 hours for 3 doses on Day 1, every 21 days, was a dose-finding study designed to determine the maximum tolerated dose (MTD) and safety of this dosing schedule in participants with advanced cancer
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
- •Males and females, 18 or older
- •Histologically or cytologically confirmed diagnosis of solid tumor malignancy
- •Measurable or non-measurable disease as defined by Response Evaluation Criteria In Solid Tumors (RECIST) criteria
- •Karnofsky Performance Status (KPS) of 70-100
- •Recovered from toxicities resulting from previous therapies
排除标准
- •More than 3 prior cytotoxic regimens in the metastatic setting
- •Current or recent gastrointestinal (GI) disease that would impact the absorption of study drug
- •Inability to swallow whole capsules
- •Inadequate hepatic and renal function
- •Function exposure to any epothilone
研究组 & 干预措施
1
干预措施: Ixabepilone (oral formulation) (Drug)
结局指标
主要结局
Number of Participants With a Dose-Limiting Toxicity (DLT)
时间窗: During Cycle 1 (Day 0 through Day 21)
DLT: any of the following, considered related to ixabepilone, occurring in Cycle 1: Absolute neutrophil count (ANC) \<500 cells/mm\^3 for ≥5 consecutive days or febrile neutropenia of any duration; Grade(Gr)4 thrombocytopenia \<25,000 cells/mm\^3 or Gr3 with bleeding requiring platelet transfusion; Gr3/4 nausea, vomiting, or diarrhea despite use of adequate intervention, fatigue, any other clinically significant drug-related ≥Gr 3 non-hematologic toxicity, delayed recovery (to Gr ≤1 or baseline, except alopecia) from toxicity which delays initiation of Cycle 2 by ≥3 weeks.
Ixabepilone Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (R2PD)
时间窗: At the end of Cycle 1 (21 days).
The MTD was defined as the maximum dose which could be given to 6 participants such that not more than 1 participant experienced a DLT (or fewer than one-third if there were more than 6 treated participants) with at least 2 participants experiencing a DLT at the next higher dose level. The R2PD was to be based on the MTD and the assessment of any relevant chronic toxicities.
次要结局
- Number of Participants With Adverse Event (AE), AE Leading to Discontinuation, Treatment-related AE, Treatment-related AE Leading to Discontinuation (DC), Most Common Treatment-Related Nonhematologic AE (>25%), Serious AE (SAE), or Treatment-related SAE(From first study drug administration through 30 days post dose)
- Number of Participants With Most Common Treatment-Related Nonhematologic AEs (>25%)(From first study drug administration through 30 days post dose)
- Number Of Participants With Liver Function and Renal Laboratory Abnormalities(From first study drug administration through 30 days post dose)
- Maximum QTc Interval on Day 1 and Maximum Change From Baseline for QTc Interval(Baseline (Day -1) and Day 1)
- PK: Mean Plasma Concentration Of Ixabepilone By Nominal Collection Time(Time 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 12.5, 13, 14, 15, 16, 17, 18, 20, 48, 72, and 168 hours post dose)
- Best Overall Response(Tumor assessments performed on Day 1 of every other cycle of therapy, until disease progression or toxicity)
- Number of Participants With Hematology Laboratory Abnormalities(From first study drug administration through 30 days post dose)