Phase I/II Study of Ixazomib With Pegylated IFN-alpha 2b (pIFN) in Metastatic Renal Cell Carcinoma (mRCC)
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Non-hematologic Toxicity ≥ Grade 3 Per CTCAE v4 Except:
研究概览
简要总结
This is a Phase I/II trial of the combination pegylated IFN-alpha 2b with ixazomib in metastatic renal cell carcinoma (mRCC). Researchers believe that by disabling the protein complex NF-kB, which controls the transfer of genetic information; using the study drug Ixazomib, they can promote necrotic cell death of RCC using interferon alpha - 2b. They hypothesize that the combination of ixazomib with IFN will lead to increased necrotic cell death in RCC tumors and consequent clinical benefit to patients.
Patients will receive ixazomib capsules and pegylated IFN alfa 2b injection in this research study. Treatments will be given weekly and 4 weeks of treatment make up one cycle.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Ixazomib and pegylated IFN alfa - 2b
Ixazomib capsules and pegylated IFN alfa 2b injections weekly. Ixazomib will be taken for the last 3 weeks of 28 day cycle. Pegylated IFN alfa 2b injection will be administered weekly, each week of the 28 day cycle.
干预措施: Ixazomib (Drug)
Ixazomib and pegylated IFN alfa - 2b
Ixazomib capsules and pegylated IFN alfa 2b injections weekly. Ixazomib will be taken for the last 3 weeks of 28 day cycle. Pegylated IFN alfa 2b injection will be administered weekly, each week of the 28 day cycle.
干预措施: Pegylated IFN-alpha 2b (Drug)
结局指标
主要结局
Non-hematologic Toxicity ≥ Grade 3 Per CTCAE v4 Except:
时间窗: Up to week 8
* Grade 3 nausea or Grade 3 vomiting ≤ 72 hours that recovers to grade 0-2 with maximal antiemetic therapy. * Grade 3 diarrhea that resolves to grade 0-2 with loperamide or diphenoxylate/atropine within 48 hours. * Grade 3 hypercholesterolemia, hypertriglyceridemia, hyperglycemia or hypophosphatemia that resolves to grade 0-2 with medical management. * Transient electrolyte abnormalities lasting ≤ 1 week.
Thrombocytopenia ≥ Grade 3 Per CTCAE v4
时间窗: Up to week 8
Grade 4 Neutropenia Per CTCAE v4; Associated With Fever or Hospitalization for Infection
时间窗: Up to week 8
Grade 4 Neutropenia Per CTCAE v4; Lasting Longer Than 5 Days
时间窗: Up to week 8
Any Toxicity Felt at the Investigator's Discretion to be Possibly or Probably Related to Ixazomib That Causes the Patient to Miss More Than 1 Dose of Either Ixazomib or pIFN in the First 28 Days.
时间窗: 28 Days
Any Unacceptable Toxicity (UT) Defined as Any CTCAE v4 Grade 5 Toxicity, Grade 4 Neuropsychiatric Toxicity or Grade 4 Clinically Significant Non-hematologic Toxicity Thought to be Definitely, Probably or Possibly Related to Study Drug.
时间窗: 28 Days
Progression Free Survival Per RECIST 1.1
时间窗: At week 8
Progression Free Survuval Per RECIST 1.1
时间窗: At week 16
次要结局
- Overall Response Rate(Week 16)