A Phase 1/2 Study Evaluating ABT-751 in Combination With Alimta in Advanced Non-Small Cell Lung Cancer
- Conditions
- Lung CancerNSCLCNon-Small-Cell Lung Cancer
- Interventions
- Registration Number
- NCT00297089
- Lead Sponsor
- AbbVie (prior sponsor, Abbott)
- 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 is currently enrolling subjects in Phase 2.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 165
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A ABT-751 Pemetrexed + ABT-751 A pemetrexed Pemetrexed + ABT-751 B pemetrexed Pemetrexed + placebo B placebo Pemetrexed + placebo
- Primary Outcome Measures
Name Time Method Progression-free Survival Subjects may remain on study until disease progression.
- Secondary Outcome Measures
Name Time Method Overall Survival Subjects may remain on study until disease progression. Response Rate Subjects may remain on study until disease progression. Time-to-Progression (TTP) Subjects may remain on study until disease progression.
Trial Locations
- Locations (48)
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 St. Lucie, Florida, United States
Site Reference ID/Investigator# 3807
🇺🇸Atlanta, Georgia, United States
Site Reference ID/Investigator# 3353
🇺🇸Chicago, Illinois, United States
Scroll for more (38 remaining)Site Reference ID/Investigator# 3358🇺🇸Fayetteville, Arkansas, United States