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

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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00539331

Enrollment

Registered

2007-10-04

Start date

2007-09-30

Completion date

2008-09-30

Last updated

2011-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Non-small Cell Lung Cancer, NSCLC, AZD2171, Paclitaxel/Carboplatin, Non-small Cell Lung Cancer (NSCLC)

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.

Interventions

DRUGAZD2171

oral tablet

DRUGPaclitaxel

intravenous infusion

DRUGCarboplatin

intravenous injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	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

Measure	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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026