Phase 1 Umbrella Trial of Erlotinib In Combination With Select Tyrosine Kinase Inhibitors In Adult Patients With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- To establish the safety, tolerability, and maximum tolerated dose (MTD) of the erlotinib-lenvatinib and erlotinib-axitinib combinations in adult patients with advanced solid tumors
研究概览
简要总结
Cancers that return or spread after their first line of treatment are often difficult to treat with limited next step options. Based on preclinical studies, the EGFR-targeting tyrosine kinase inhibitor (TKI) Erlotinib may be better in stopping or slowing the growth of tumors when given in combination with the multitargeting TKI Lenvatinib or Axitinib. Participants will be screened with a physical exam and tests including urine and blood tests, imaging scans, and a test of their heart function. Erlotinib, axitinib, and lenvatinib are all capsules taken by mouth. All participants will take their drugs at home every day. Some participants will take erlotinib plus lenvatinib once a day. Some participants will take erlotinib once a day and axitinib twice a day. Assignment to one of the treatment arms will be determined by the study. Participants will record their doses in a diary. Treatment is given in 28-day cycles. All participants will have 4 clinic visits during their first treatment cycle. After that, they will have a clinic visit at the start of each new cycle. Imaging scans, blood and urine tests, and other tests will be repeated during various clinic visits. Participants will remain in the study for as long as the treatment is helping them. They will have follow-up phone calls after they stop treatment....
详细描述
Primary Objective:
-To establish the safety, tolerability, and maximum tolerated dose (MTD) of the erlotinib-lenvatinib and erlotinib-axitinib combinations in adult patients with advanced solid tumors
Secondary Objective:
-To evaluate the plasma pharmacokinetic profiles of erlotinib and either lenvatinib or axitinib when used in combination
Exploratory Objectives:
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 120 Years（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
A
Erlotinib with lenvatinib combination
干预措施: Lenvatinib (Drug)
A
Erlotinib with lenvatinib combination
干预措施: Erlotinib (Drug)
B
Erlotinib with axitinib combination
干预措施: Erlotinib (Drug)
B
Erlotinib with axitinib combination
干预措施: Axitinib (Drug)
结局指标
主要结局
To establish the safety, tolerability, and maximum tolerated dose (MTD) of the erlotinib-lenvatinib and erlotinib-axitinib combinations in adult patients with advanced solid tumors
时间窗: 30 months
This is an open-label phase 1 umbrella trial with 2 treatment arms. All agents will be administered orally in 28-day cycles. The starting dose level (DL) will be DL 1A for Arm A (the erlotinib-lenvatinib combination arm) and DL 1B for Arm B (the erlotinib-axitinib combination arm). Dose escalation on both arms will follow a 3+3 design. Intrapatient dose escalation to the next highest cleared dose level will be permitted upon completion of \>= 1 cycle of therapy at the current dose level at which the patient is being treated. Dose-limiting toxicities will be defined during the first cycle of treatment. Patients will be assigned to one of the two treatment arms in an alternating fashion.
次要结局
- To evaluate the plasma pharmacokinetic profiles of erlotinib and either lenvatinib or axitinib when used in combination(30 months)