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AZD6244 Versus Pemetrexed (Alimta®) in Patients With Non-small Cell Lung Cancer, Who Have Failed One or Two Prior Chemotherapy Regimen

Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT00372788
Collaborator
(none)
88
Enrollment
8
Locations
2
Arms
28
Duration (Months)
11
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the effect and safety of AZD6244(ARRY-142886)versus pemetrexed in the second or third line treatment of advanced Non-Small Cell Lung Cancer. Following baseline assessments, a minimum of 64 patients in approximately 5-6 centers from the US will be treated with either AZD6244 or pemetrexed. Treatment will be continued for as long as patients receive clinical benefit.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
88 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II, Open, Randomised Study to Assess the Efficacy and Safety of AZD6244 Versus Pemetrexed (Alimta®) in Patients With Non-small Cell Lung Cancer, Who Have Failed One or Two Prior Chemotherapy Regimen
Study Start Date :
Aug 1, 2006
Actual Primary Completion Date :
Jul 1, 2007
Actual Study Completion Date :
Dec 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 1

Pemetrexed

Drug: Pemetrexed
oral
Other Names:
  • Alimta®

    		•
    Experimental: 2

    AZD6244

    Drug: AZD6244
    oral vial
    Other Names:
  • ARRY-142886

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Assess tumor growth [assessed every 12 weeks]

    Secondary Outcome Measures

    1. Assess safety and tolerability of AZD6244 [assessed at each visit]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Diagnosed with non-small cell lung cancer

    • Previously received one or two chemotherapeutic treatments

    Exclusion Criteria:

    • Previous therapy with MEK inhibitor or pemetrexed

    • Any recent surgery, unhealed surgical incision or severe condition such as uncontrolled cardiac disease or chronic gastrointestinal diseases

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Los Angeles California United States
    2 Research Site Ann Arbor Michigan United States
    3 Research Site New York New York United States
    4 Research Site Nashville Tennessee United States
    5 Research Site Plovdiv Bulgaria
    6 Research Site Sofia Bulgaria
    7 Research Site Varna Bulgaria
    8 Research Site Cluj-Napoca Romania

    Sponsors and Collaborators

    • AstraZeneca

    Investigators

    • Study Director: Emerging Oncology Medical Science Director, MD, AstraZeneca

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    AstraZeneca
    ClinicalTrials.gov Identifier:
    NCT00372788
    Other Study ID Numbers:
    • D1532C00012
    First Posted:
    Sep 7, 2006
    Last Update Posted:
    Aug 13, 2014
    Last Verified:
    Aug 1, 2014
    Keywords provided by AstraZeneca
    NSCLC
    Advanced Non-Small Cell Lung Cancer
    AZD6244
    Additional relevant MeSH terms:
    Lung Neoplasms
    Carcinoma, Non-Small-Cell Lung
    Pemetrexed

    Study Results

    No Results Posted as of Aug 13, 2014