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

About this trial
This is an interventional treatment trial for Lung Cancer focused on measuring Lung Cancer, Non-Small Cell Lung Cancer, NSCLC, ABT-751, docetaxel, Taxotere
Eligibility Criteria
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
Sites / Locations
- Site Ref # / Investigator 3572
- Site Ref # / Investigator 4771
- Site Ref # / Investigator 3574
- Site Ref # / Investigator 3567
- Site Ref # / Investigator 3512
- Site Ref # / Investigator 3565
- Site Ref # / Investigator 3569
- Site Ref # / Investigator 3511
- Site Ref # / Investigator 5237
- Site Ref # / Investigator 3551
- Site Ref # / Investigator 3549
- Site Ref # / Investigator 3571
- Site Ref # / Investigator 3510
- Site Ref # / Investigator 3563
- Site Ref # / Investigator 3559
- Site Ref # / Investigator 3561
- Site Ref # / Investigator 3560
- Site Ref # / Investigator 3562
- Site Ref # / Investigator 2222
- Site Ref # / Investigator 3558
- Site Ref # / Investigator 5097
- Site Ref # / Investigator 4986
- Site Ref # / Investigator 4999
- Site Ref # / Investigator 5158
- Site Ref # / Investigator 4971
- Site Ref # / Investigator 5270
- Site Ref # / Investigator 5259
- Site Ref # / Investigator 5271
- Site Ref # / Investigator 5017
- Site Ref # / Investigator 5274
- Site Ref # / Investigator 5273
- Site Ref # / Investigator 5268
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
A
B
Docetaxel + ABT-751
Docetaxel + placebo