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

Sponsor
AstraZeneca (Industry)
Overall Status
Terminated
CT.gov ID
NCT00539331
Collaborator
(none)
6
Enrollment
2
Locations
2
Arms
12
Duration (Months)
3
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

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
Phase 1

Study Design

Study Type:
Interventional
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 :
Sep 1, 2007
Actual Primary Completion Date :
Sep 1, 2008
Actual Study Completion Date :
Sep 1, 2008

Arms and Interventions

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: AZD2171
    oral tablet
    Other Names:
  • cediranib
  • RECENTIN™

    • Drug: Paclitaxel
    intravenous infusion
    Other Names:
  • Taxol®

    • Drug: Carboplatin
    intravenous injection
    Other Names:
  • CBDCA
  • 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 [Assessed at each visit during Part A]

    2. PART B : Assess the efficacy of AZD2171 by assessment of progression free survival (PFS) [time to progression]

    Secondary Outcome Measures

    1. PART A : To examine the effect of AZD2171 on the PK of carboplatin and paclitaxel [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 to death]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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

    Locations

    Site City State Country Postal Code
    1 Research Site Osaka Japan
    2 Research Site Tokyo Japan

    Sponsors and Collaborators

    • AstraZeneca

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00539331
    Other Study ID Numbers:
    • D8480C00040
    First Posted:
    Oct 4, 2007
    Last Update Posted:
    Jun 1, 2011
    Last Verified:
    May 1, 2011
    Keywords provided by , ,
    Non-small Cell Lung Cancer
    NSCLC
    AZD2171
    Paclitaxel/Carboplatin
    Non-small Cell Lung Cancer (NSCLC)
    Additional relevant MeSH terms:
    Carcinoma, Non-Small-Cell Lung
    Paclitaxel
    Carboplatin
    Cediranib

    Study Results

    No Results Posted as of Jun 1, 2011