Study of Lenalidomide in Combination With Sunitinib to Evaluate the Safety and Efficacy in Patients With Renal Cell Carcinoma
A Phase 1/2, Multicenter, Open-Label, Dose-Escalation Study to Evaluate the Safety and Efficacy of Lenalidomide in Combination With Sunitinib in Subjects With Advanced or Metastatic Renal Cell Carcinoma
研究概览
研究类型
注册 (实际的)
阶段
- 阶段2
- 阶段1
联系人和位置
学习地点
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Michigan
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Ann Arbor、Michigan、美国、48109
- University of Michigan Comprehensive Cancer Center
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Ohio
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Cleveland、Ohio、美国、44195
- Cleveland Clinic Main Campus
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Tennessee
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Nashville、Tennessee、美国、37203
- Tennessee Oncology
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Metastatic Renal Cell Carcinoma.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.
Exclusion Criteria:
- Prior chemotherapy.
- Prior treatment with lenalidomide, thalidomide, pomalidomide, or sunitinib.
- Laboratory values outside normal ranges.
- Myocardial infarction (MI) within past 12 months.
- Current congestive heart failure.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:非随机化
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Cohort A
Participants received an oral dose of lenalidomide MTD (mg) capsule administered in combination with a single dose of sunitinib 37.5 mg on days 1-21 of each 21-day cycle
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Lenalidomide MTD mg by mouth (PO) daily for Days 1- 21 in combination
其他名称:
Sunitinib 37.5 mg PO daily on days 1-21 of each 21-day cycle in Cohort A or on days 1-14 in Cohorts F and G
其他名称:
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实验性的:Cohorts F and G
Participants received an oral daily dose of lenalidomide on Days 1 to 21 in combination with a single oral daily dose of sunitinib 37.5 mg on days 1 to 14 or days 1 to 21 of each 21-day cycle
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Lenalidomide MTD mg by mouth (PO) daily for Days 1- 21 in combination
其他名称:
Sunitinib 37.5 mg PO daily on days 1-21 of each 21-day cycle in Cohort A or on days 1-14 in Cohorts F and G
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Phase 1: Maximum Tolerated Dose (MTD)
大体时间:Within 21 days of first dose of treatment
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The MTD of lenalidomide in combination with sunitinib was defined as the highest dose level at which no more than 1 out of 6 participants experienced a dose limiting toxicity (DLT). Dose limiting toxicities were: • Inability to deliver Lenalidomide in Cycle 1 due to a drug-related toxicity resulting in:
If ≤ 7 doses of lenalidomide or Sunitinib were missed in Cycle 1 due to non-drug related event, the participant data was to be included in the evaluation of dose escalation. |
Within 21 days of first dose of treatment
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Phase 2: Tumor Response Rate According to Response Evaluation Criteria In Solid Tumors (RECIST 1.1)
大体时间:After at least 3 cycles of treatment
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Tumor response was to be evaluated every 3 cycles beginning with Cycle 3 Day 1 and at treatment discontinuation. Response was to be defined by RECIST 1.1 criteria:
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After at least 3 cycles of treatment
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Phase 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) While on Both Lenalidomide and Sunitinib
大体时间:First day of study drug to within 28 days after the last dose of the last study drug; The duration of exposure to lenalidomide and sunitinib was 7.0 to 327 and 7.0 to 328 days respectively
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Adverse event (AE) = any noxious, unintended, or untoward medical occurrence occurring at any dose that may appear or worsen in a participant during the course of a study, including new intercurrent illness, worsening concomitant illness, injury, or any concomitant impairment of participants health, including laboratory test values, regardless of etiology.
Serious adverse event (SAE) = any AE which: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event.
TEAE = any AE occurring or worsening on or after the first treatment with any study drug.
Related = suspected by investigator to be related to study treatment.
National Cancer Institute [NCI] Common Toxicity Criteria for Adverse Events [CTCAE], Version 4.0, grades: 1 = mild, 2 = moderate, 3 = severe, 4 = life threatening, 5 = death
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First day of study drug to within 28 days after the last dose of the last study drug; The duration of exposure to lenalidomide and sunitinib was 7.0 to 327 and 7.0 to 328 days respectively
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Phase 1 : Tumor Response Rate According to RECIST 1.1
大体时间:Every 3 cycles; up to month 25
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Tumor response was evaluated every 3 cycles beginning with Cycle 3 Day 1 and at treatment discontinuation. Response was evaluated using the Response Criteria Evaluation in Solid Tumors (RECIST 1.1) criteria: Treatment response includes both complete response and partial response
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Every 3 cycles; up to month 25
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Progression Free Survival (PFS)
大体时间:Day 1 of study drug to disease progression or death
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Progression-free survival was defined as the time from the start of study drug therapy to the first observation of disease progression or death due to any cause, whichever came first.
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Day 1 of study drug to disease progression or death
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Duration of Response
大体时间:Day 1 of initial response date to progressive disease
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Duration of response was defined as the time from the initial response date to progressive disease (PD) for participants who achieved an objective confirmed complete response (CR) or partial response (PR)
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Day 1 of initial response date to progressive disease
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Overall Survival (OS)
大体时间:Day 1 of study drug to death
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Overall survival was defined as the time from the start of study drug therapy to death.
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Day 1 of study drug to death
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合作者和调查者
赞助
调查人员
- 研究主任:Debora Barton, MD、Celgene Corporation
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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Lenalidomide的临床试验
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University of Alabama at BirminghamJanssen Scientific Affairs, LLC; Amgen完全的