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Effectiveness of KOS-862 in the Treatment of Lung Cancer

Primary Purpose

Lung Cancer

Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
KOS-862
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: At least 18 years of age Measurable disease One previous treatment of a platinum based drug such as cisplatin or carboplatin At least 3 weeks since last surgery/radiation/chemotherapy Exclusion Criteria: Brain metastases Changes in the rhythm of your heart that are considered significant as determined by an ECG tracing

Sites / Locations

    Outcomes

    Primary Outcome Measures

    NSCLC

    Secondary Outcome Measures

    Full Information

    First Posted
    April 5, 2004
    Last Updated
    February 2, 2010
    Sponsor
    Bristol-Myers Squibb
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00080509
    Brief Title
    Effectiveness of KOS-862 in the Treatment of Lung Cancer
    Official Title
    A Phase 2 Study of KOS-862, Administered Intravenously Weekly for 3 Weeks Every 4 Weeks, in Patients With Non-Small Cell Lung Cancer Who Have Progressed Following Initial Therapy for Advanced or Metastatic Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2009
    Overall Recruitment Status
    Terminated
    Study Start Date
    December 2003 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    November 2004 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Bristol-Myers Squibb

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to determine whether a potential drug known as KOS-862 or "Epothilone D" has an effect as a 2nd line treatment in non-small cell lung cancer (NSCLC) for patients having failed one prior platinum-containing chemotherapy regimen.
    Detailed Description
    To determine the antitumor activity, based on the confirmed objective response rate, of KOS-862, administered intravenously weekly for 3 weeks every 4 weeks, in patients with non-small cell lung cancer (NSCLC) whose disease has progressed following initial chemotherapy for advanced or metastatic disease.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lung Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    85 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    KOS-862
    Primary Outcome Measure Information:
    Title
    NSCLC

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: At least 18 years of age Measurable disease One previous treatment of a platinum based drug such as cisplatin or carboplatin At least 3 weeks since last surgery/radiation/chemotherapy Exclusion Criteria: Brain metastases Changes in the rhythm of your heart that are considered significant as determined by an ECG tracing

    12. IPD Sharing Statement

    Learn more about this trial

    Effectiveness of KOS-862 in the Treatment of Lung Cancer

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