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
18 Years
N/A
Both
Carcinoma, Non-Small-Cell Lung
Trial Information
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
Inclusion Criteria:
- Having histologically or cytologically confirmed NSCLC
- Patients with previously untreated advanced/metastatic (Stage IIIB/IV) or postsurgery
recurrent NSCLC
- WHO performance status 0-1
Exclusion Criteria:
- Untreated unstable brain or meningeal metastases
- Patient with inappropriate laboratory tests values
- Patient with poorly controlled hypertension
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
PART A : Safety and tolerability of AZD2171 in combination with pac/carbo in patients with non-small cell lung cancer
Outcome Time Frame:
Assessed at each visit during Part A
Safety Issue:
No
Principal Investigator
Jane Robertson
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca
Authority:
Japan: Pharmaceuticals and Medical Devices Agency
Study ID:
D8480C00040
NCT ID:
NCT00539331
Start Date:
September 2007
Completion Date:
September 2008
Related Keywords:
- Carcinoma, Non-Small-Cell Lung
- Non-small Cell Lung Cancer
- NSCLC
- AZD2171
- Paclitaxel/Carboplatin
- Non-small Cell Lung Cancer (NSCLC)
- Carcinoma
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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