A Two-Part Study in Japanese Patients With Advanced or Metastatic NSCLC. Open-Label Phase I to Assess the Safety & Tolerability of AZD2171 in Combination With Pac/Carb, Then a Phase II, Randomised, Double-Blind Study to Assess the Efficacy of Pac/Carb Alone and in Combination With AZD2171 and Pac/Carb
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- AstraZeneca
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- PART A : Safety and tolerability of AZD2171 in combination with pac/carbo in patients with non-small cell lung cancer
研究概览
简要总结
The National Cancer Institute of Canada Clinical Trials Group (NCIC-CTG) has informed AstraZeneca that the BR24 Phase II/III study of cediranib at 30mg in first line non-small cell lung cancer (NSCLC) will not continue into Phase III following the planned end of Phase II efficacy and tolerability analysis by the study's Data Safety Monitoring Committee. Although evidence of clinical activity was seen, there appeared to be an imbalance in toxicity and therefore the study was considered not to have met the pre-defined criteria for automatic continuation into Phase III. As the design of Study 040 is similar to that of Study BR24, AstraZeneca has suspended recruitment into Study 040.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Having histologically or cytologically confirmed NSCLC
- •Patients with previously untreated advanced/metastatic (Stage IIIB/IV) or postsurgery recurrent NSCLC
- •WHO performance status 0-1
排除标准
- •Untreated unstable brain or meningeal metastases
- •Patient with inappropriate laboratory tests values
- •Patient with poorly controlled hypertension
研究组 & 干预措施
1
Paclitaxel/Carboplatin
干预措施: Paclitaxel (Drug)
1
Paclitaxel/Carboplatin
干预措施: Carboplatin (Drug)
2
Paclitaxel/Carboplatin + AZD2171
干预措施: AZD2171 (Drug)
2
Paclitaxel/Carboplatin + AZD2171
干预措施: Paclitaxel (Drug)
2
Paclitaxel/Carboplatin + AZD2171
干预措施: Carboplatin (Drug)
结局指标
主要结局
PART A : Safety and tolerability of AZD2171 in combination with pac/carbo in patients with non-small cell lung cancer
时间窗: Assessed at each visit during Part A
PART B : Assess the efficacy of AZD2171 by assessment of progression free survival (PFS)
时间窗: time to progression
次要结局
- PART A : To examine the effect of AZD2171 on the PK of carboplatin and paclitaxel(Assessed at each visit during Part A)
- PART B : To determine the efficacy of AZD2171 by assessment of overall response rate, change in tumour size and overall survival(time to death)
