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

January 5, 2011 updated by: Abbott

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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: Docetaxel
Standard Docetaxel every 21 days
Other Names:
  • Taxotere
Drug: Placebo
Placebo daily for 14 days every 21 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-free Survival
Time Frame: Subjects may remain on study until disease progression
Subjects may remain on study until disease progression

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Survival
Time Frame: Subject may remain on study until disease progression
Subject may remain on study until disease progression
Response Rate
Time Frame: Subject may remain on study until disease progression
Subject may remain on study until disease progression
Time-to-Progression (TTP)
Time Frame: Subject may remain on study until disease progression
Subject may remain on study until disease progression

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (ACTUAL)

February 1, 2008

Study Registration Dates

First Submitted

July 18, 2006

First Submitted That Met QC Criteria

July 18, 2006

First Posted (ESTIMATE)

July 20, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

January 7, 2011

Last Update Submitted That Met QC Criteria

January 5, 2011

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M05-782
  • 2006-002838-38 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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