Status:
COMPLETED
A Phase 1/2 Study Evaluating ABT-751 in Combination With Alimta in Advanced Non-Small Cell Lung Cancer
Lead Sponsor:
AbbVie (prior sponsor, Abbott)
Conditions:
Lung Cancer
NSCLC
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
To determine the efficacy of ABT-751 when administered in combination with standard pemetrexed in subjects with advanced or metastatic NSCLC. The Phase 1 portion of the study is complete and the study...
Eligibility Criteria
Inclusion
- 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 0-2
- 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
- Greater than Grade 1 neurological findings
- Allergy to sulfa medications
- Previous treatment with ABT-751 or pemetrexed
- 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
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
165 Patients enrolled
Trial Details
Trial ID
NCT00297089
Start Date
November 1 2006
End Date
January 1 2009
Last Update
January 31 2013
Active Locations (48)
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1
Site Reference ID/Investigator# 3358
Fayetteville, Arkansas, United States, 72703
2
Site Reference ID/Investigator# 4102
Hot Springs, Arkansas, United States, 71913
3
Site Reference ID/Investigator# 2127
Greenbrae, California, United States, 94904
4
Site Reference ID/Investigator# 2417
Fort Collins, Colorado, United States, 80524