Phase I Study of Ixabepilone Administered as a 24-Hour Infusion in Patients With Advanced Solid Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 3
- 主要终点
- Number of Participants With Dose Limiting Toxicities at Dose Level
研究概览
简要总结
The purpose of this study is to determine the dose limiting toxicities, minimum tolerated dose and recommended dose for Phase II studies.
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
- •confirmed diagnosis of a primary solid tumor
- •measurable or non-measurable disease
- •progressive disease
- •men and women greater or equal to 18 years of age.
排除标准
- •women of child bearing potential who are not using birth control
- •women who are pregnant or breast feeding
- •women with a positive pregnancy test on enrollment
- •patients with brain metastasis
- •prior treatment with Ixabepilone
- •known history of human immunodeficiency virus (HIV)
研究组 & 干预措施
A1
干预措施: Ixabepilone (Drug)
结局指标
主要结局
Number of Participants With Dose Limiting Toxicities at Dose Level
时间窗: Measures taken at Cycle 01 (21-day cycle)
Dose limiting toxicities=any of the following events attributed to Ixabepilone occuring during the first cycle: grade 3/4 nausea, vomiting, or diarrhea despite medical intervention and/or prophylaxis; other Grade ≥3 nonhematological toxicity; any toxicity requiring study therapy discontinuation; delayed recovery from study therapy-related toxicity which delays scheduled re-treatment for \>14 days; Grade 4 neutropenia for ≥5 consecutive days; grade 3/4 neutropenia with sepsis or a fever ≥38.5 C; thrombocytopenia \<25,000 cells/mm3 or bleeding requiring a platelet transfusion.
次要结局
- Best Tumor Response, According to Response Evaluation Criteria in Solid Tumors (RECIST)(At Baseline (up to 2 weeks prior to starting therapy), after every 2nd cycle, and at post study follow-upn after a maximum of 9 cycles.)
- Treatment Related Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and AEs Leading to Discontinuation(From time of screening through post study follow-up at a maximum of 21 9-day cycles. Toxicity assessments occured at least every 4 weeks until all study drug related toxicities.)
- Hematology Results - Worst On-Study Grade(Baseline (within 2 weeks of dosing), weekly, and within 72 hours prior to each subsequent 21-day cycle. If CTC Grade 4 hematologic toxicity is observed, complete blood count plus differential and platelets repeated every 3 days until resolution.)
- Mean Plasma Concentration of Ixabepilone at 40 mg/m2 Dose Level(through 72 hours after start of infusion)