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A Phase 2 Study Evaluating ABT-751 in Combination With Taxotere in Advanced Non-Small Cell Lung Cancer

Sponsor
Abbott (Industry)
Overall Status
Terminated
CT.gov ID
NCT00354562
Collaborator
(none)
75
Enrollment
32
Locations
2
Arms
2.3
Patients Per Site

Study Details

Study Description

Brief Summary

To determine the efficacy of ABT-751 when administered in combination with standard docetaxel in subjects with advanced or metastatic NSCLC.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
75 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 1/2 Study Evaluating the Safety and Efficacy of ABT-751 in Combination With Docetaxel Versus Docetaxel Alone in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer
Study Start Date :
Feb 1, 2007
Actual Primary Completion Date :
Feb 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: A

Docetaxel + ABT-751

Drug: ABT-751
200mg ABT-751 daily for 14 days every 21 days

Drug: Docetaxel
Standard Docetaxel every 21 days
Other Names:
  • Taxotere

    		•
    Placebo Comparator: B

    Docetaxel + placebo

    Drug: Placebo
    Placebo daily for 14 days every 21 days

    Drug: Docetaxel
    Standard Docetaxel every 21 days
    Other Names:
  • Taxotere

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Progression-free Survival [Subjects may remain on study until disease progression]

    Secondary Outcome Measures

    1. Overall Survival [Subject may remain on study until disease progression]

    2. Response Rate [Subject may remain on study until disease progression]

    3. Time-to-Progression (TTP) [Subject may remain on study until disease progression]

    Eligibility Criteria

    Criteria

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

    • Pathologically documented NSCLC

    • Locally advanced (Stage III) or metastatic (Stage IV) NSCLC

    • Only one prior anti-tumor treatment regimen in the non-curative setting (i.e., 2nd-line therapy)

    • Only one prior anti-tumor treatment regimen in the curative setting

    • Progressive disease following the previous anti-tumor treatment regimen

    • Measurable disease by RECIST criteria

    • Brain metastasis must be stable and well-controlled

    ECOG performance score 0-2All anti-tumor therapy discontinued at least 3 weeks prior to study entryAll adverse events from prior treatment are resolved or stableAdequate hematologic, renal, and hepatic functionFemales must not be pregnantWilling to take adequate measures to prevent pregnancyLife expectancy of at least 3 monthsAble to complete the Quality of Life questionnaireVoluntarily signed informed consent

    • Only one prior anti-tumor treatment regimen in the curative setting

    • Progressive disease following the previous anti-tumor treatment regimen

    • Measurable disease by RECIST criteria

    • Brain metastasis must be stable and well-controlled

    • ECOG performance score 0-2

    • All anti-tumor therapy discontinued at least 3 weeks prior to study entry

    • All adverse events from prior treatment are resolved or stable

    • Adequate hematologic, renal, and hepatic function

    • Females must not be pregnant

    • Willing to take adequate measures to prevent pregnancy

    • Life expectancy of at least 3 months

    • Able to complete the Quality of Life questionnaire

    • Voluntarily signed informed consent

    Exclusion Criteria:

    • Greater that Grade 1 neurological findings

    • Allergy to sulfa medications

    • Previous treatment with ABT-751 or docetaxel

    • Receipt of more than one investigational agent for NSCLC

    • Significant weight loss (>10%) within 6 weeks of study entry

    • Glucose-6-phosphate dehydrogenase deficiency or porphyria

    • Significant systemic disease that would adversely affect participation

    • Class 3-4 New York Heart Association classification status

    • Other cancers except in situ carcinoma of the cervix, basal or squamous cell skin cancer, or any other cancer considered adequately treated and cured by the investigator

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Site Ref # / Investigator 3572 Birmingham Alabama United States 35294-3300
    2 Site Ref # / Investigator 4771 Burbank California United States 91505
    3 Site Ref # / Investigator 3574 Orange California United States 92868-3298
    4 Site Ref # / Investigator 3567 Rancho Mirage California United States 92270
    5 Site Ref # / Investigator 3512 Gurnee Illinois United States 60031
    6 Site Ref # / Investigator 3565 Hackensack New Jersey United States 07601
    7 Site Ref # / Investigator 3569 Buffalo New York United States 14215
    8 Site Ref # / Investigator 3511 Cleveland Ohio United States 44195
    9 Site Ref # / Investigator 5237 Ravenna Ohio United States 44266
    10 Site Ref # / Investigator 3551 Crossville Tennessee United States 38555
    11 Site Ref # / Investigator 3549 Knoxville Tennessee United States 37920
    12 Site Ref # / Investigator 3571 Nashville Tennessee United States 37232-6307
    13 Site Ref # / Investigator 3510 Weston Wisconsin United States 54476
    14 Site Ref # / Investigator 3563 Sydney Nova Scotia Canada B1P 1P3
    15 Site Ref # / Investigator 3559 Barrie Ontario Canada L4M 6M2
    16 Site Ref # / Investigator 3561 Sudbury Ontario Canada P3E 5J1
    17 Site Ref # / Investigator 3560 Greenfield Park Quebec Canada J4V 2H1
    18 Site Ref # / Investigator 3562 Montreal Quebec Canada H2W 1S6
    19 Site Ref # / Investigator 2222 Montreal Quebec Canada H3T 1E2
    20 Site Ref # / Investigator 3558 Regina Saskatchewan Canada S4T 7T1
    21 Site Ref # / Investigator 5097 Cork Ireland
    22 Site Ref # / Investigator 4986 Dublin 24 Ireland
    23 Site Ref # / Investigator 4999 Dublin 4 Ireland
    24 Site Ref # / Investigator 5158 Dublin 7 Ireland
    25 Site Ref # / Investigator 4971 Dublin 8 Ireland
    26 Site Ref # / Investigator 5270 Barming United Kingdom ME16 9QQ
    27 Site Ref # / Investigator 5259 Belfast United Kingdom BT9 7AB
    28 Site Ref # / Investigator 5271 Edinburgh United Kingdom EH42XU
    29 Site Ref # / Investigator 5017 Glasgow United Kingdom G12 0YN
    30 Site Ref # / Investigator 5274 Hull United Kingdom HU8 9HE
    31 Site Ref # / Investigator 5273 Surrey United Kingdom GU2 7XX
    32 Site Ref # / Investigator 5268 Surrey United Kingdom SM2 5NG

    Sponsors and Collaborators

    • Abbott

    Investigators

    • Study Director: Helen Eliopoulos, MD, Abbott

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00354562
    Other Study ID Numbers:
    • M05-782
    • 2006-002838-38
    First Posted:
    Jul 20, 2006
    Last Update Posted:
    Jan 7, 2011
    Last Verified:
    Sep 1, 2010
    Keywords provided by , ,
    Lung Cancer
    Non-Small Cell Lung Cancer
    NSCLC
    ABT-751
    docetaxel
    Taxotere
    Additional relevant MeSH terms:
    Lung Neoplasms
    Carcinoma, Non-Small-Cell Lung
    Docetaxel

    Study Results

    No Results Posted as of Jan 7, 2011