A Study of ARRY-334543 and Docetaxel 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
- 27
- 试验地点
- 3
- 主要终点
- Characterize the pharmacokinetics (PK) of study drug and docetaxel.
研究概览
简要总结
This is a Phase 1 study during which patients with advanced/metastatic solid tumors will receive investigational study drug ARRY-334543 and docetaxel (with prophylactic growth factor support). Patients will receive increasing doses of study drug in combination with docetaxel in order to achieve the highest dose of study drug possible that will not cause unacceptable side effects. Patients will be followed to see what side effects the combination causes and what effectiveness the combination has, if any, in treating the cancer. Approximately 30 patients from the US will be enrolled in this study.
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
- •Histologically or cytologically confirmed diagnosis of any advanced/metastatic solid tumor suitable for treatment with docetaxel.
- •Tumor recurred or progressed following at least one line of chemotherapy, except if no standard of care exists or if the patient refuses standard of care treatment.
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or
- •Must be able to take and retain oral medications.
- •Other criteria exist.
排除标准
- •Active concomitant malignancies.
- •Uncontrolled or symptomatic brain metastases (if a patient has brain metastases and is on steroids, the steroid dose must be stable for at least 30 days prior to study start).
- •Known positive serology for the human immunodeficiency virus (HIV), hepatitis B and/or hepatitis C.
- •Requiring intravenous (IV) alimentation.
- •Pregnancy or lactation.
- •Chemotherapy, anticancer immunotherapy, monoclonal antibodies or biologics within 21 days prior to first dose of study drug.
- •Anti-ErbB1 and/or ErbB2 targeted therapy or anticancer hormonal therapy within 14 days prior to first dose of study drug.
- •History of hypersensitivity to or intolerance of docetaxel.
- •Other criteria exist.
研究组 & 干预措施
ARRY-334543 + docetaxel + prophylactic growth factors
干预措施: ARRY-334543, EGFR/ErbB2 inhibitor; oral (Drug)
ARRY-334543 + docetaxel + prophylactic growth factors
干预措施: Docetaxel, mitotic inhibitor; intravenous (Drug)
ARRY-334543 + docetaxel + prophylactic growth factors
干预措施: Prophylactic growth factors; subcutaneous (Drug)
结局指标
主要结局
Characterize the pharmacokinetics (PK) of study drug and docetaxel.
时间窗: Duration of study
Establish the maximum tolerated dose (MTD) of study drug in combination with docetaxel.
时间窗: Duration of study
Characterize the safety profile of study drug in combination with docetaxel in terms of adverse events, clinical laboratory tests and electrocardiograms.
时间窗: Duration of study
次要结局
- Assess the efficacy of the study drug in combination with docetaxel in terms of tumor response.(Duration of study)