NCT00539331

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2007

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 2, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 4, 2007

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

June 1, 2011

Status Verified

May 1, 2011

Enrollment Period

1 year

First QC Date

October 2, 2007

Last Update Submit

May 30, 2011

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Non-small Cell Lung CancerNSCLCAZD2171Paclitaxel/CarboplatinNon-small Cell Lung Cancer (NSCLC)

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • 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

Study Arms (2)

1

PLACEBO COMPARATOR

Paclitaxel/Carboplatin

Drug: PaclitaxelDrug: Carboplatin

2

EXPERIMENTAL

Paclitaxel/Carboplatin + AZD2171

Drug: AZD2171Drug: PaclitaxelDrug: Carboplatin

Interventions

AZD2171DRUG

oral tablet

Also known as: cediranib, RECENTIN™
2
PaclitaxelDRUG

intravenous infusion

Also known as: Taxol®
12
CarboplatinDRUG

intravenous injection

Also known as: CBDCA, Paraplatin®
12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Having histologically or cytologically confirmed NSCLC
  • Patients with previously untreated advanced/metastatic (Stage IIIB/IV) or postsurgery recurrent NSCLC
  • WHO performance status 0-1

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Research Site

Osaka, Japan

Location

Research Site

Tokyo, Japan

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

cediranibPaclitaxelCarboplatin

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesCoordination Complexes

Study Officials

  • Jane Robertson

    AstraZeneca

    STUDY DIRECTOR

  • Masahiro Fukuoka, MD

    Sakai hospital Kinki University School of Medicine

    PRINCIPAL INVESTIGATOR

  • Xiaojin Shin, MD

    AstraZeneca

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 2, 2007

First Posted

October 4, 2007

Study Start

September 1, 2007

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

June 1, 2011

Record last verified: 2011-05

Locations

JP(2)