NCT02811822已完成1 期
A Phase I Open-Label Dose Escalation Study to Determine the Efficacy, Safety and Pharmacokinetics of GMI-1271 as Adjunct to Standard of Care Chemotherapy for the Treatment of Multiple Myeloma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 8
- 主要终点
- Safety assessed by frequency, severity and relatedness of AEs
研究概览
简要总结
This study will evaluate GMI-1271, a specific E-selectin antagonist, in multiple myeloma as adjunct to standard of care chemotherapy used to treat this disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Males and females ≥ 18 years of age
- •Confirmed diagnosis of Multiple Myeloma
- •Subjects with progressive MM who have received at least 1 prior therapy and who have already undergone or are not expected to undergo hematopoietic stem cell transplantation
- •Subjects previously treated with an IMiD-based regimen or ineligible for an IMiD-based treatment regimen
- •Subjects must be receiving treatment with a proteasome inhibitor-based regimen (bortezomib-based or carfilzomib-based)
- •Adequate hepatic, renal, and cardiac function
排除标准
- •Intolerant to bortezomib or carfilzomib
- •Progressing evidence of end organ damage attributed to the underlying disease
- •Plasma cell leukemia
- •Congestive heart failure
- •Acute active infection
- •Non-hematologic malignancy within the past 3 years except: a) adequately treated basal cell or squamous cell skin cancer, b) carcinoma in situ of the cervix, or c) prostate cancer with stable PSA
- •Significant peripheral neuropathy
研究组 & 干预措施
Dose 1
Experimental
干预措施: GMI-1271 (Drug)
Dose 2
Experimental
干预措施: GMI-1271 (Drug)
Dose 3
Experimental
干预措施: GMI-1271 (Drug)
Dose 4
Experimental
干预措施: GMI-1271 (Drug)
结局指标
主要结局
Safety assessed by frequency, severity and relatedness of AEs
时间窗: up to 6 months
Assessed by frequency, severity and relatedness of AEs
Overall Response Rate
时间窗: up to 18 months
Overall Response Rate = Stringent Complete Response + Complete Response + Very Good Partial Response + Partial Response
次要结局
- Time to response(18 months)
- Time to progression(18 months)
- Duration of response(18 months)
- Clinical benefit rate = Stringent Complete Response + Complete Response + Very Good Partial Response + Partial Response + Minimal Response + Stable Disease(18 months)
- Progression free survival(18 months)
- Overall survival(18 months)
- Time versus plasma concentration profile of GMI-1271(up to Day 23 of Cycle 1 (each cycle is 21 or 28 days))
研究者
研究点 (8)
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