A Phase 2, Open-Label Study To Evaluate The Efficacy And Safety Of Lenalidomide In Combination With Cetuximab In Pretreated Subjects With K-Ras Mutant Metastatic Colorectal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 51
- 试验地点
- 17
- 主要终点
- Participants With Dose Limiting Toxicities (DLTs) During the First Treatment Cycle of the Safety Lead-In Period
研究概览
简要总结
The purpose of this study is to determine whether lenalidomide in combination with cetuximab is safe and effective in patients with KRAS mutant colorectal cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Metastatic colorectal adenocarcinoma.
- •Confirmed K-RAS mutant tumor
- •Disease progression on oxaliplatin- AND irinotecan-containing regimens, with at least one of these regimens containing bevacizumab.
- •Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.
排除标准
- •Use of chemotherapy, hormonal therapy, immunotherapy or any other cancer or experimental treatment ≤ 28 days prior to the first day of the first cycle.
- •Radiotherapy for up to ≥ 30% of the bone marrow.
- •Surgery ≤ 28 days before day 1 of the first cycle (minimally invasive interventions for diagnostic purposes or disease staging are permitted).
- •Previous treatment with cetuximab, panitumumab, pomalidomide (CC-4047), lenalidomide or thalidomide.
- •Untreated, symptomatic brain metastases (brain imaging not required).
- •Venous thromboembolism ≤ 6 months before day1 of the first cycle.
- •Current congestive heart failure (classes II to IV of the New York Heart Association).
- •Myocardial infarction ≤ 12 months before day1 of the first cycle.
- •Uncontrolled hypertension.
研究组 & 干预措施
lenalidomide plus cetuximab
Combination therapy of lenalidomide plus cetuximab
干预措施: cetuximab (Drug)
lenalidomide plus cetuximab
Combination therapy of lenalidomide plus cetuximab
干预措施: lenalidomide (Drug)
lenalidomide
Single agent therapy of lenalidomide
干预措施: lenalidomide (Drug)
结局指标
主要结局
Participants With Dose Limiting Toxicities (DLTs) During the First Treatment Cycle of the Safety Lead-In Period
时间窗: Up to Day 28 (Cycle 1)
The number of participants with DLTs determines the maximum tolerated dose of the combination therapy used in the Proof of Concept (POC) period: If \<2 of the initial 6 participants experience a DLT, then the POC will start with lenalidomide at 25 mg. If ≥2 of the initial 6 participants experienced a DLT, then 6 more subjects were to be enrolled at 20 mg lenalidomide. If \<2 of the additional 6 subjects experienced a DLT, then the lenalidomide starting dose for the POC was to be 20 mg. If ≥2 of the additional 6 subjects experienced a DLT, then 6 more subjects were to be enrolled at 15 mg lenalidomide. If \<2 of the additional 6 subjects experienced a DLT, then the POC was to start with lenalidomide at 15 mg. If ≥2 of the additional 6 subjects experienced a DLT, the dosing for the study was to be reassessed by Celgene Corporation and the investigators.
Percentage of Participants With a Response to Treatment During the Proof of Concept Period
时间窗: week 9 up to week 24
Tumor response was evaluated every 2 cycles beginning with Cycle 3 Day 1 and at treatment discontinuation. Response and progression were evaluated using the RECIST 1.1 criteria (Eisenhauer, 2009). Treatment response includes both complete response and partial response. * Complete response-disappearance of all lesions * Partial response-30% decrease in the sum of diameters of target lesions from baseline Analysis was not performed due to the early termination of the study.
次要结局
- Kaplan-Meier Estimates for Progression Free Survival (PFS)(up to week 24)
- Kaplan-Meier Estimates for Duration of Response(up to week 24)
- Percentage of Participants With Disease Control(up to week 24)
- Kaplan-Meier Estimates for Overall Survival(up to 5.5 years)
- Participants With Treatment-Emergent Adverse Events (TEAE)(up to week 28)