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

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ClinicalTrials.gov Identifier: NCT00539331
Recruitment Status : Terminated
First Posted : October 4, 2007
Last Update Posted : June 1, 2011
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Drug: AZD2171 Drug: Paclitaxel Drug: Carboplatin Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2007
Primary Completion Date : September 2008
Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: 1
Drug: Paclitaxel
intravenous infusion
Other Name: Taxol®
Drug: Carboplatin
intravenous injection
Other Names:
  • Paraplatin®
Experimental: 2
Paclitaxel/Carboplatin + AZD2171
Drug: AZD2171
oral tablet
Other Names:
  • cediranib
Drug: Paclitaxel
intravenous infusion
Other Name: Taxol®
Drug: Carboplatin
intravenous injection
Other Names:
  • Paraplatin®

Outcome Measures

Primary Outcome Measures :
  1. 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 ]
  2. PART B : Assess the efficacy of AZD2171 by assessment of progression free survival (PFS) [ Time Frame: time to progression ]

Secondary Outcome Measures :
  1. PART A : To examine the effect of AZD2171 on the PK of carboplatin and paclitaxel [ Time Frame: Assessed at each visit during Part A ]
  2. 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 ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00539331

Research Site
Osaka, Japan
Research Site
Tokyo, Japan
Sponsors and Collaborators
Study Director: Jane Robertson AstraZeneca
Principal Investigator: Masahiro Fukuoka, MD Sakai hospital Kinki University School of Medicine
Study Chair: Xiaojin Shin, MD AstraZeneca
More Information

Responsible Party: Jane Robertson, MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT00539331     History of Changes
Other Study ID Numbers: D8480C00040
First Posted: October 4, 2007    Key Record Dates
Last Update Posted: June 1, 2011
Last Verified: May 2011

Keywords provided by AstraZeneca:
Non-small Cell Lung Cancer
Non-small Cell Lung Cancer (NSCLC)

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors