A Phase 2 Study Evaluating ABT-751 in Combination With Taxotere in Advanced Non-Small Cell Lung Cancer
NCT ID: NCT00354562
Last Updated: 2011-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1/PHASE2
75 participants
INTERVENTIONAL
2007-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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A
Docetaxel + ABT-751
ABT-751
200mg ABT-751 daily for 14 days every 21 days
Docetaxel
Standard Docetaxel every 21 days
B
Docetaxel + placebo
Placebo
Placebo daily for 14 days every 21 days
Docetaxel
Standard Docetaxel every 21 days
Interventions
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ABT-751
200mg ABT-751 daily for 14 days every 21 days
Placebo
Placebo daily for 14 days every 21 days
Docetaxel
Standard Docetaxel every 21 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Abbott
INDUSTRY
Responsible Party
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Abbott
Principal Investigators
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Helen Eliopoulos, MD
Role: STUDY_DIRECTOR
Abbott
Locations
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Site Ref # / Investigator 3572
Birmingham, Alabama, United States
Site Ref # / Investigator 4771
Burbank, California, United States
Site Ref # / Investigator 3574
Orange, California, United States
Site Ref # / Investigator 3567
Rancho Mirage, California, United States
Site Ref # / Investigator 3512
Gurnee, Illinois, United States
Site Ref # / Investigator 3565
Hackensack, New Jersey, United States
Site Ref # / Investigator 3569
Buffalo, New York, United States
Site Ref # / Investigator 3511
Cleveland, Ohio, United States
Site Ref # / Investigator 5237
Ravenna, Ohio, United States
Site Ref # / Investigator 3551
Crossville, Tennessee, United States
Site Ref # / Investigator 3549
Knoxville, Tennessee, United States
Site Ref # / Investigator 3571
Nashville, Tennessee, United States
Site Ref # / Investigator 3510
Weston, Wisconsin, United States
Site Ref # / Investigator 3563
Sydney, Nova Scotia, Canada
Site Ref # / Investigator 3559
Barrie, Ontario, Canada
Site Ref # / Investigator 3561
Greater Sudbury, Ontario, Canada
Site Ref # / Investigator 3560
Greenfield Park, Quebec, Canada
Site Ref # / Investigator 3562
Montreal, Quebec, Canada
Site Ref # / Investigator 2222
Montreal, Quebec, Canada
Site Ref # / Investigator 3558
Regina, Saskatchewan, Canada
Site Ref # / Investigator 5097
Cork, , Ireland
Site Ref # / Investigator 4971
Dublin, , Ireland
Site Ref # / Investigator 4986
Dublin, , Ireland
Site Ref # / Investigator 4999
Dublin, , Ireland
Site Ref # / Investigator 5158
Dublin, , Ireland
Site Ref # / Investigator 5259
Belfast, , United Kingdom
Site Ref # / Investigator 5270
East Barming, , United Kingdom
Site Ref # / Investigator 5271
Edinburgh, , United Kingdom
Site Ref # / Investigator 5017
Glasgow, , United Kingdom
Site Ref # / Investigator 5274
Hull, , United Kingdom
Site Ref # / Investigator 5273
Surrey, , United Kingdom
Site Ref # / Investigator 5268
Surrey, , United Kingdom
Countries
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Other Identifiers
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2006-002838-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M05-782
Identifier Type: -
Identifier Source: org_study_id
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