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

AstraZeneca

Status and phase: Terminated; Phase 1

Conditions: Carcinoma, Non-Small-Cell Lung

Treatments: Drug: Paclitaxel; Drug: Carboplatin; Drug: AZD2171

Study type: Interventional

Funder types: Industry

Identifiers

NCT00539331

D8480C00040

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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6 participants in 2 patient groups, including a placebo group

1

Placebo Comparator group

Description:

Paclitaxel/Carboplatin

Treatment:

Drug: Carboplatin

Drug: Paclitaxel

2

Experimental group

Description:

Paclitaxel/Carboplatin + AZD2171

Treatment:

Drug: Carboplatin

Drug: AZD2171

Drug: Paclitaxel