Phase I/II Study of AZD2171 in combination with Paclitaxel/Carboplatin in Japanese Non-Small Cell Lung Cancer Patients
Study identifier:D8480C00040
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Terminated/Withdrawn
Official Title
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
Medical condition
Carcinoma, Non-Small-Cell Lung
Phase
Phase 1
Healthy volunteers
No
Study drug
AZD2171, Paclitaxel, Carboplatin
Sex
All
Actual Enrollment
6
Study type
Interventional
Age
18 Years +
Date
Study Start Date: 01 Sept 2007
Primary Completion Date: 01 Sept 2008
Study Completion Date: 01 Sept 2008
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: 1 Paclitaxel/Carboplatin | Drug: Paclitaxel intravenous infusion Other Name: Taxol® Drug: Carboplatin intravenous injection Other Name: CBDCA Other Name: Paraplatin® |
| Experimental: 2 Paclitaxel/Carboplatin + AZD2171 | Drug: AZD2171 oral tablet Other Name: cediranib Other Name: RECENTIN™ Drug: Paclitaxel intravenous infusion Other Name: Taxol® Drug: Carboplatin intravenous injection Other Name: CBDCA Other Name: Paraplatin® |
Contacts
Investigators
Principal Investigator
Jane Robertson
AstraZeneca
