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# 3353
🇺🇸Chicago, Illinois, United States
Site Reference ID/Investigator# 6006
🇺🇸Philadelphia, Pennsylvania, United States
Site Reference ID/Investigator# 2411
🇺🇸Fort Lauderdale, Florida, United States
Site Reference ID/Investigator# 2416
🇺🇸Baltimore, Maryland, United States
Site Reference ID/Investigator# 3362
🇺🇸Worcester, Massachusetts, United States
Site Reference ID/Investigator# 2075
🇺🇸Kalamazoo, Michigan, United States
Site Reference ID/Investigator# 4170
🇺🇸St. Louis, Missouri, United States
Site Reference ID/Investigator# 2413
🇺🇸Columbus, Ohio, United States
Site Reference ID/Investigator# 2244
🇺🇸Baltimore, Maryland, United States
Site Reference ID/Investigator# 3319
🇳🇱Eindhoven, Netherlands
Site Reference ID/Investigator# 3359
🇺🇸Indianapolis, Indiana, United States
Site Reference ID/Investigator# 3411
🇨🇿Pribram, Czech Republic
Site Reference ID/Investigator# 3333
🇭🇺Miskolc, Hungary
Site Reference ID/Investigator# 2418
🇺🇸Jefferson City, Missouri, United States
Site Reference ID/Investigator# 2070
🇺🇸Tacoma, Washington, United States
Site Reference ID/Investigator# 3341
🇳🇱Haraderwijk, Netherlands
Site Reference ID/Investigator# 4687
🇨🇿Brno, Czech Republic
Site Reference ID/Investigator# 3405
🇬🇷Heraklion, Greece
Site Reference ID/Investigator# 3354
🇺🇸Bethelem, Pennsylvania, United States
Site Reference ID/Investigator# 3337
🇨🇿Brno, Czech Republic
Site Reference ID/Investigator# 3327
🇨🇿Olomouc, Czech Republic
Site Reference ID/Investigator# 3793
🇺🇸Peabody, Massachusetts, United States
Site Reference ID/Investigator# 3344
🇨🇿Prague 2, Czech Republic
Site Reference ID/Investigator# 3328
🇨🇿Novy Jicin, Czech Republic
Site Reference ID/Investigator# 3343
🇨🇿Ostrava-Poruba, Czech Republic
Site Reference ID/Investigator# 3363
🇺🇸Lakeland, Florida, United States
Site Reference ID/Investigator# 5690
🇺🇸Torrington, Connecticut, United States
Site Reference ID/Investigator# 3357
🇺🇸Lebanon, New Hampshire, United States
Site Reference ID/Investigator# 3358
🇺🇸Fayetteville, Arkansas, United States
Site Reference ID/Investigator# 2127
🇺🇸Greenbrae, California, United States
Site Reference ID/Investigator# 4102
🇺🇸Hot Springs, Arkansas, United States
Site Reference ID/Investigator# 2417
🇺🇸Fort Collins, Colorado, United States
Site Reference ID/Investigator# 3807
🇺🇸Atlanta, Georgia, United States
Site Reference ID/Investigator# 3352
🇺🇸Port St. Lucie, Florida, United States
Site Reference ID/Investigator# 2401
🇺🇸Bethesda, Maryland, United States
Site Reference ID/Investigator# 2242
🇺🇸Huntersville, North Carolina, United States
Site Reference ID/Investigator# 4278
🇨🇿Kyjov, Czech Republic
Site Reference ID/Investigator# 3342
🇨🇿Prague 4, Czech Republic
Site Reference ID/Investigator# 3403
🇬🇷Thessaloniki, Greece
Site Reference ID/Investigator# 3406
🇬🇷Thessaloniki, Greece
Site Reference ID/Investigator# 3332
🇭🇺Szekesfehervar, Hungary
Site Reference ID/Investigator# 3331
🇭🇺Budapest, Hungary
Site Reference ID/Investigator# 3409
🇳🇱Amsterdam, Netherlands
Site Reference ID/Investigator# 3410
🇸🇰Martin, Slovakia
Site Reference ID/Investigator# 3528
🇳🇱Hoorn, Netherlands
Site Reference ID/Investigator# 3400
🇸🇰Bratislava, Slovakia
Site Reference ID/Investigator# 2414
🇺🇸Bristol, Tennessee, United States
Site Reference ID/Investigator# 5098
🇺🇸Lake Success, New York, United States