Phase 2 Trial Of AG-013736 As First-Line Treatment For Patients With Squamous Non-Small Cell Lung Cancer Receiving Treatment With Cisplatin And Gemcitabine
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Objective Response (OR)
研究概览
简要总结
This study will evaluate whether AG-013736 when combined with cisplatin and gemcitabine shows activity and is safe in patients with squamous type of non-small cell lung cancer
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 squamous NSCLC Stage IIIB with malignant effusion (fluid cytology demonstrating malignant cells required), Stage IV, or recurrent disease after definitive local therapy
- •Candidate for primary treatment with cisplatin and gemcitabine
- •Presence of measurable disease by RECIST
- •Adequate organ function as defined by the following criteria: ECOG performance status of 0 or 1
排除标准
- •Prior systemic treatment for Stage IIIB (with malignant effusion) or Stage IV NSCLC.
- •One or more lung lesions with cavitation, or any lesion invading or abutting a major blood vessel as assessed by CT or MRI.
- •History of hemoptysis > ½ tsp (2.5 ml) of blood per day for a day or more within 1 week of study treatment, or Grade 3 or 4 hemoptysis within 4 weeks of study treatment
- •NCI CTCAE Grade 3 hemorrhage from any cause within 4 weeks of study treatment
- •Preexisting uncontrolled hypertension as documented by 2 baseline blood pressure readings taken at least 1 hour apart.
- •Untreated brain metastases.
- •Need for therapeutic anticoagulation, regular use of aspirin (> 325 mg/day), NSAID or other medications known to inhibit platelet function.
研究组 & 干预措施
AG-013736/Cisplatin/Gemcitabine
干预措施: AG-013736 (Drug)
AG-013736/Cisplatin/Gemcitabine
干预措施: gemcitabine (Drug)
AG-013736/Cisplatin/Gemcitabine
干预措施: cisplatin (Drug)
结局指标
主要结局
Percentage of Participants With Objective Response (OR)
时间窗: Baseline until disease progression or discontinuation from the study due to any cause, assessed every 6 weeks during chemotherapy phase and every 8 weeks during single agent phase up to final study visit (Week 78)
Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed response are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are those with disappearance of all target lesions. PR are those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions.
次要结局
- Duration of Response (DR)(Baseline until disease progression or discontinuation from the study due to any cause, assessed every 6 weeks during chemotherapy phase and every 8 weeks during single agent phase up to final study visit (Week 78))
- Overall Survival (OS)(Baseline until death or assessed every 2 months (up to 28 days after the last dose))
- Progression Free Survival (PFS)(Baseline, assessed every 2 months (up to 28 days after the last dose))