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Phase 2 Study of TLK286 Administered Weekly in Advanced Non-Small Cell Lung Cancer

Sponsor
Telik (Industry)
Overall Status
Completed
CT.gov ID
NCT00040638
Collaborator
(none)
40
Enrollment
3
Locations
13
Duration (Months)
13.3
Patients Per Site
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the effectiveness of TLK286 in the treatment of advanced non-small cell lung cancer.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Study Start Date :
Jul 1, 2002
Actual Primary Completion Date :
Aug 1, 2003
Actual Study Completion Date :
Aug 1, 2003

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

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

    • Histologic or cytologic diagnosis of non-small cell lung carcinoma

    • Progressed while on or after treatment on platinum-based regimen

    • Patients may not have had more than one prior cytotoxic chemotherapy regimen

    • Stage IV or IIIB

    • Age at least 18 years

    • Adequate liver and kidney function

    • Adequate bone marrow function

    Exclusion Criteria:

    • Pregnancy or lactation

    • Unstable medical conditions

    • Chemotherapy, hormonal therapy, radiotherapy, radiopharmaceuticals or immunotherapy within 3 weeks of TLK286

    • CNS metastasis unless controlled by treatment

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Arizona Cancer Center Tucson Arizona United States 85724
    2 UCLA Medical Center Los Angeles California United States 90095
    3 M.D. Anderson Cancer Center Houston Texas United States 77030

    Sponsors and Collaborators

    • Telik

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00040638
    Other Study ID Numbers:
    • TLK286.2014
    First Posted:
    Jul 4, 2002
    Last Update Posted:
    Jul 25, 2011
    Last Verified:
    Jun 1, 2011
    Additional relevant MeSH terms:
    Carcinoma, Non-Small-Cell Lung

    Study Results

    No Results Posted as of Jul 25, 2011