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

Phase 1TerminatedNCT00539331

AstraZeneca6 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

PART A : Safety and tolerability of AZD2171 in combination with pac/carbo in patients with non-small cell lung cancer

Time frame: Assessed at each visit during Part A

PART B : Assess the efficacy of AZD2171 by assessment of progression free survival (PFS)

Time frame: time to progression

Secondary Outcomes

PART A : To examine the effect of AZD2171 on the PK of carboplatin and paclitaxel