A Study of ARRY-334543 in Patients With Advanced Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Characterize the pharmacokinetics (PK) of the new formulation of study drug (in terms of plasma concentrations) when administered in a fed versus fasted state.
研究概览
简要总结
This is a Phase 1 study during which patients with advanced solid tumors will receive a new formulation of investigational study drug ARRY-334543. Patients will receive increasing doses of study drug in order to achieve the highest dose possible that will not cause unacceptable side effects. The patients will be followed to see what side effects and effectiveness the study drug has, if any, in treating the cancer. In addition, the effect of food on the new formulation will be evaluated. Approximately 24 patients from Canada will be enrolled in this study (Active, not recruiting).
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
- •Histological or cytological evidence of malignancy.
- •Patients with advanced solid tumors who are no longer candidates for standard therapy, have no standard therapy available, or choose not to pursue standard therapy.
- •Cardiac ejection fraction ≥ 50% by echocardiogram (ECHO) or multiple gated acquisition (MUGA).
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or
- •Additional criteria exist.
排除标准
- •Uncontrolled brain metastases (if a patient has brain metastases and is on steroids, the steroid dose must be stable for at least 30 days).
- •Use of an investigational medication or device within 30 days prior to first dose of study drug.
- •Major surgery within 30 days prior to first dose of study drug.
- •Radiotherapy or chemotherapy within 28 days prior to first dose of study drug (not including palliative radiotherapy at focal sites).
- •Active, uncontrolled infection requiring systemic antibiotic therapy or other serious underlying medical condition which would impair the ability of the patient to receive protocol treatment.
- •Pregnancy or lactation.
- •Known positive serology for the human immunodeficiency virus (HIV), 'active' hepatitis B and/or hepatitis C.
- •Additional criteria exist.
研究组 & 干预措施
ARRY-334543
干预措施: ARRY-334543, EGFR/ErbB2 inhibitor; oral (Drug)
结局指标
主要结局
Characterize the pharmacokinetics (PK) of the new formulation of study drug (in terms of plasma concentrations) when administered in a fed versus fasted state.
时间窗: Day 1 and Day 8
Characterize the safety profile of the new formulation of study drug in terms of adverse events, clinical laboratory tests and electrocardiograms.
时间窗: Duration of study
Establish the maximum tolerated dose (MTD) of the new formulation of study drug.
时间窗: Duration of study
Assess the exposure of the new formulation of study drug in terms of plasma concentrations.
时间窗: Duration of study
次要结局
- Assess the efficacy of the new formulation of study drug in terms of tumor dimension assessment.(Duration of study)