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

• Status: Completed
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: All

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 is currently enrolling subjects in Phase 2.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie (prior sponsor, Abbott)
• Treatments: Pemetrexed

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 0-2

• 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 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