A Phase 1/2 Study Evaluating ABT-751 in Combination With Alimta in Advanced Non-Small Cell Lung Cancer

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Lung Cancer, NSCLC, Non-Small-Cell Lung Cancer

In brief

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 is currently enrolling subjects in Phase 2.

Key facts

Study ID

NCT00297089

Run by

AbbVie (prior sponsor, Abbott)

People needed

165

Starts

2006-11-01

Expected to finish

2009-01-01

Last updated by the study team

2013-01-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Site Reference ID/Investigator# 3358 — Fayetteville, Arkansas, United States
• Site Reference ID/Investigator# 4102 — Hot Springs, Arkansas, United States
• Site Reference ID/Investigator# 2127 — Greenbrae, California, United States
• Site Reference ID/Investigator# 2417 — Fort Collins, Colorado, United States
• Site Reference ID/Investigator# 5690 — Torrington, Connecticut, United States
• Site Reference ID/Investigator# 2411 — Fort Lauderdale, Florida, United States
• Site Reference ID/Investigator# 3363 — Lakeland, Florida, United States
• Site Reference ID/Investigator# 3352 — Port Saint Lucie, Florida, United States
• Site Reference ID/Investigator# 3807 — Atlanta, Georgia, United States
• Site Reference ID/Investigator# 3353 — Chicago, Illinois, United States
• Site Reference ID/Investigator# 3359 — Indianapolis, Indiana, United States
• Site Reference ID/Investigator# 2416 — Baltimore, Maryland, United States
• Site Reference ID/Investigator# 2244 — Baltimore, Maryland, United States
• Site Reference ID/Investigator# 2401 — Bethesda, Maryland, United States
• Site Reference ID/Investigator# 3793 — Peabody, Massachusetts, United States
• Site Reference ID/Investigator# 3362 — Worcester, Massachusetts, United States
• Site Reference ID/Investigator# 2075 — Kalamazoo, Michigan, United States
• Site Reference ID/Investigator# 2418 — Jefferson City, Missouri, United States
• Site Reference ID/Investigator# 4170 — St Louis, Missouri, United States
• Site Reference ID/Investigator# 3357 — Lebanon, New Hampshire, United States
• Site Reference ID/Investigator# 5098 — Lake Success, New York, United States
• Site Reference ID/Investigator# 2242 — Huntersville, North Carolina, United States
• Site Reference ID/Investigator# 2413 — Columbus, Ohio, United States
• Site Reference ID/Investigator# 3354 — Bethelem, Pennsylvania, United States
• Site Reference ID/Investigator# 6006 — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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