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

May 30, 2011 updated by: AstraZeneca

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

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Osaka, Japan
        • Research Site
      • Tokyo, Japan
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 1
Paclitaxel/Carboplatin
Drug: Paclitaxel
intravenous infusion
Other Names:
  • Taxol®
Drug: Carboplatin
intravenous injection
Other Names:
  • CBDCA
  • Paraplatin®
Experimental: 2
Paclitaxel/Carboplatin + AZD2171
Drug: Paclitaxel
intravenous infusion
Other Names:
  • Taxol®
Drug: Carboplatin
intravenous injection
Other Names:
  • CBDCA
  • Paraplatin®
Drug: AZD2171
oral tablet
Other Names:
  • RECENTIN™
  • cediranib

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
time to progression

Secondary Outcome Measures

Outcome Measure
Time Frame
PART A : To examine the effect of AZD2171 on the PK of carboplatin and paclitaxel
Time Frame: Assessed at each visit during Part A
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 Frame: time to death
time to death

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Masahiro Fukuoka, MD, Sakai hospital Kinki University School of Medicine
  • Study Chair: Xiaojin Shin, MD, AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

October 2, 2007

First Submitted That Met QC Criteria

October 3, 2007

First Posted (Estimate)

October 4, 2007

Study Record Updates

Last Update Posted (Estimate)

June 1, 2011

Last Update Submitted That Met QC Criteria

May 30, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D8480C00040

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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