跳至主要内容
临床试验/NCT00539331
NCT00539331终止1 期

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

AstraZeneca1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2007年9月最近更新:
适应症
干预措施
相关药物

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

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

Placebo Comparator

Paclitaxel/Carboplatin

干预措施: Paclitaxel (Drug)

1

Placebo Comparator

Paclitaxel/Carboplatin

干预措施: Carboplatin (Drug)

2

Experimental

Paclitaxel/Carboplatin + AZD2171

干预措施: AZD2171 (Drug)

2

Experimental

Paclitaxel/Carboplatin + AZD2171

干预措施: Paclitaxel (Drug)

2

Experimental

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)

研究者

发起方
AstraZeneca
申办方类型
Industry

研究点 (1)

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