A Study of ARRY-334543 and Capecitabine 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
- 29
- 试验地点
- 4
- 主要终点
- Characterize the safety profile of study drug in combination with capecitabine in terms of adverse events, clinical laboratory tests and electrocardiograms.
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 capecitabine. Patients will receive increasing doses of study drug in combination with capecitabine 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 and Canada 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 cancer suitable for treatment with capecitabine. Pancreatic cancer is not allowed and patients with gastric or gastroesophageal junction (GEJ) cancer are only eligible if prior treatment did not include a total gastrectomy.
- •Target lesions may be in a previously irradiated field only if progression of the lesion has been clearly documented.
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or
- •Must be able to take and retain oral medications.
- •Additional 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).
- •Known dihydropyrimidine dehydrogenase (DPD) deficiency.
- •Requiring intravenous (IV) alimentation.
- •Known positive serology for the human immunodeficiency virus (HIV), hepatitis B and/or hepatitis C.
- •Pregnancy or lactation.
- •Chemotherapy, anticancer immunotherapy, monoclonal antibodies or biologics within 21 days prior to first dose of study drug.
- •Anti-EGFR and/or ErbB2 small molecule targeted therapy or hormonal anticancer therapy within 14 days prior to first dose of study drug.
- •History of any hypersensitivity to or intolerance of capecitabine or any of its components, or to fluorouracil or any fluoropyrimidine therapy.
- •Additional criteria exist.
研究组 & 干预措施
ARRY-334543 + capecitabine
干预措施: ARRY-334543, EGFR/ErbB2 inhibitor; oral (Drug)
ARRY-334543 + capecitabine
干预措施: Capecitabine, 5-fluorouracil prodrug; oral (Drug)
结局指标
主要结局
Characterize the safety profile of study drug in combination with capecitabine in terms of adverse events, clinical laboratory tests and electrocardiograms.
时间窗: Duration of study
Characterize the pharmacokinetics (PK) of study drug and capecitabine.
时间窗: Duration of study
Establish the maximum tolerated dose (MTD) of study drug in combination with capecitabine.
时间窗: Duration of study
次要结局
- Assess potential predictive biomarkers of clinical activity for the study drug in combination with capecitabine.(Duration of study)
- Assess the efficacy of the study drug in combination with capecitabine in terms of tumor response and changes in serological tumor markers.(Duration of study)