Phase I/II Study of AZD2171 in Combination With Paclitaxel/Carboplatin in Japanese Non-Small Cell Lung Cancer Patients

Study Overview
=================
Brief Summary
-----------------
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.

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

Conditions
-----------------
Carcinoma, Non-Small-Cell Lung

Intervention / Treatment
-----------------
* Drug: AZD2171
* Drug: Paclitaxel
* Drug: Carboplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Paclitaxel/Carboplatin | Drug: Paclitaxel<br>* intravenous infusion<br>* Other names: Taxol®;Drug: Carboplatin<br>* intravenous injection<br>* Other names: Paraplatin®;|
| Experimental: 2<br>Paclitaxel/Carboplatin + AZD2171 | Drug: AZD2171<br>* oral tablet<br>* Other names: RECENTIN™;Drug: Paclitaxel<br>* intravenous infusion<br>* Other names: Taxol®;Drug: Carboplatin<br>* intravenous injection<br>* Other names: Paraplatin®;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PART A : Safety and tolerability of AZD2171 in combination with pac/carbo in patients with non-small cell lung cancer |  | Assessed at each visit during Part A | 
| PART B : Assess the efficacy of AZD2171 by assessment of progression free survival (PFS) |  | time to progression | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Non-small Cell Lung Cancer, NSCLC, AZD2171, Paclitaxel/Carboplatin, Non-small Cell Lung Cancer (NSCLC)