NCT01741727已完成1 期
A Phase 1/2 Study Evaluating the Safety, Pharmacokinetics and Efficacy of ABT-414 in Subjects With Advanced Solid Tumors Likely to Over-Express the Epidermal Growth Factor Receptor (EGFR)
AbbVie (prior sponsor, Abbott)6 个研究点 分布在 2 个国家目标入组 57 人开始时间: 2012年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 57
- 试验地点
- 6
- 主要终点
- Phase 1 - Safety (Number of subjects with adverse events and/or dose limiting toxicities)
研究概览
简要总结
A study of ABT-414 in subjects with solid tumors.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must have a solid tumor type likely to over-express Epidermal Growth Factor Receptor (EGFR) (Phase 1)
- •Subjects have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
- •Subjects have available tumor tissue
- •Subjects have adequate bone marrow, renal, and hepatic function as follows: Bone marrow: Absolute neutrophil count (ANC) >/= 1,500/mm3 Platelets >/= 100,000/mm3; Hemoglobin >/= 9.0 g/dL Renal function: Serum creatinine </= 1.5 times the upper limit of the institution's normal range Hepatic function: Bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) </= 1.5 times the upper limit of the institution's normal range. Subjects with liver metastasis may have an AST and ALT of </= 5.0 x the upper limit of normal.
- •Subjects in the Phase 2 portion must have squamous cell Non-Small Cell Lung Cancer (NSCLC)
- •Eligibility is restricted to subjects with confirmed EGFR amplification in the EGFR amplified cohort
排除标准
- •The subject has uncontrolled metastases to the central nervous system (CNS). Subjects with brain metastases are eligible provided they have shown clinical and radiographic stable disease for at least 28 days after definitive therapy and have not received prior whole brain radiation (Phase 1 only).
- •The subject has received anticancer therapy including chemotherapy, immunotherapy, radiotherapy, hormonal, biologic, or any investigational therapy within a period of 28 days prior to the first dose of ABT-
- •The subject has unresolved clinically significant toxicities from prior anticancer therapy, defined as any Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or higher.
- •The subject had had major surgery within 28 days prior to the first dose of ABT-
- •The subject has a history of immunologic reaction to any Immunoglobulin G (IgG) containing agent.
- •Phase 2 portion only: The subject has previous or concurrent cancer that is distinct in primary site or histology from NSCLC, except cervical carcinoma in situ, non-melanoma carcinoma of the skin or in situ carcinoma of the bladder. Any cancer curatively treated greater than 3 years prior to entry is permitted.
研究组 & 干预措施
ABT-414
Experimental
Subjects with solid tumors (Phase 1) and squamous non-small cell lung cancer (NSCLC) (Phase 2)
干预措施: ABT-414 (Drug)
结局指标
主要结局
Phase 1 - Safety (Number of subjects with adverse events and/or dose limiting toxicities)
时间窗: Every 1-3 weeks for an average of 20 weeks
Evaluation of vital signs, clinical lab testing, adverse event monitoring, physical exam and electrocardiogram (ECG) (periodic) under different dosing schedules, drug infusion times, and manufacturing processes.
Phase 2 - Efficacy
时间窗: Every 6-9 weeks for an average of 20 weeks
Objective response per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST)
Phase 1 - Pharmacokinetic profile
时间窗: Multiple timepoints Week 1 and Week 7
Cmax, Cmin, and half-life
次要结局
- Phase 2- Pharmacokinetic profile(Multiple timepoints Week 1)
- Phase 2- Safety (Scheduled study visits occurring on average every 3 weeks)(Followed on average every 3 weeks for approximately 20 weeks)
- Phase 1&2 - QT assessment(Week 1)
研究者
研究点 (6)
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