NCT00199160已完成2 期
Efficacy and Activity of BAY 43-9006 in Patients With Recurrent and/or Metastatic Head and Neck Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- PFS
研究概览
简要总结
This is a Phase II trial evaluating the efficacy and the biological activity of BAY 43-9006 in patients with recurrent and/or metastatic head and neck cancer.
详细描述
This is a Phase II trial evaluating the efficacy and the biological activity of BAY 43-9006 in patients with recurrent and/or metastatic head and neck cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Male and female patients (18 years old and above), with a histologically proven, measurable, locally recurrent, and/or metastatic head and neck tumor.
- •> 4 weeks since major surgery
- •> 4 weeks since prior chemotherapy
- •> 3 weeks since prior therapy with biological agents (Interleukin-2 [IL-2], interferon, other molecular-targeted therapies [except Ras/Raf inhibitors]).
- •Performance status < 2
- •Life expectancy > 3 months.
- •At least one uni-dimensional measurable lesion by computed tomography (CT)-scan or magnetic resonance imaging (MRI) according to Response Evaluation Criteria in Solid Tumors (RECIST)
- •Adequate liver, pancreatic, renal, and coagulation function
- •A slide or paraffin-block from a tumor biopsy MUST be available at the time of screening. If the original diagnostic biopsy is not available at the time of screening, an additional biopsy is required.
排除标准
- •Severe preexisting conditions
- •Evidence of bone marrow suppression
- •Frequent vomiting or medical condition, which could interfere with oral medication intake
- •Lack of resolution of all toxic manifestations of prior chemotherapy, biologic, or radiation therapy (alopecia excluded).
- •Known HIV positivity or AIDS-related illness.
- •Previous exposure to a Ras/Raf inhibitor
- •Previous malignancy (except for cervical carcinoma in situ, adequately treated basal cell carcinoma, or superficial bladder tumors [Ta, Tis and T1] or other malignancies curatively treated > 2 years prior to entry)
- •Congestive heart failure
- •Cardiac arrhythmias requiring anti-arrhythmics
- •Active coronary artery disease or ischaemia
- •Active clinically serious bacterial or fungal infections
- •Known brain or meningeal metastases
- •Patients with seizure disorder requiring medication (such as anti-epileptics)
- •Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
- •Known or suspected allergy to the investigational agent or any agent given in association with this trial
- •Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test.
- •Concurrent anti-cancer chemotherapy or immunotherapy is excluded
- •Significant surgery within four weeks prior to start of study drug
- •Investigational drug therapy outside of this trial, or any chemotherapy during or within 4 weeks prior to start of study drug
- •Myelosuppressive radiotherapy within four weeks prior to start of study drug (short-course non-myelosuppressive radiotherapy may be allowed based on approval of principal investigators)
- •Concomitant treatment with ketoconazole, itraconazole, ritonavir, or use of grapefruit juice
结局指标
主要结局
PFS
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
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