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

Phase 1

Terminated

• Conditions: Carcinoma, Non-Small-Cell Lung
• Interventions: Drug: Paclitaxel; Drug: AZD2171; Drug: Carboplatin

• Registration Number: NCT00539331
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-10-02
• Study First Submitted QC: 2007-10-03
• Study First Posted: 2007-10-04
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-30
• Last Update Posted: 2011-06-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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

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Exclusion Criteria

• Untreated unstable brain or meningeal metastases
• Patient with inappropriate laboratory tests values
• Patient with poorly controlled hypertension

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Paclitaxel	Paclitaxel/Carboplatin
1	Carboplatin	Paclitaxel/Carboplatin
2	AZD2171	Paclitaxel/Carboplatin + AZD2171
2	Paclitaxel	Paclitaxel/Carboplatin + AZD2171
2	Carboplatin	Paclitaxel/Carboplatin + AZD2171

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Research Site; 🇯🇵 Tokyo, Japan