Clinical trial NCT00297089: A Phase 1/2 Study Evaluating ABT-751 in Combination With Alimta in Advanced Non-Small Cell Lung Cancer
Official title: A Phase 1/2 Study Evaluating the Safety and Efficacy of ABT 751 in Combination With Pemetrexed Versus Pemetrexed Alone in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Lung Cancer
NSCLC
Non-Small-Cell Lung Cancer
Keywords: Lung Cancer
ABT-751
NSCLC
Alimta
Non-Small-Cell Lung Cancer
pemetrexed
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2006-02-28
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Progression-free Survival
timeFrame: Subjects may remain on study until disease progression.
Secondary outcomes:
measure: Overall Survival
timeFrame: Subjects may remain on study until disease progression.
measure: Response Rate
timeFrame: Subjects may remain on study until disease progression.
measure: Time-to-Progression (TTP)
timeFrame: Subjects may remain on study until disease progression.
Other outcomes:
Locations:
city: Fayetteville
country: United States
facility: Site Reference ID/Investigator# 3358
state: Arkansas
city: Hot Springs
country: United States
facility: Site Reference ID/Investigator# 4102
state: Arkansas
city: Greenbrae
country: United States
facility: Site Reference ID/Investigator# 2127
state: California
city: Fort Collins
country: United States
facility: Site Reference ID/Investigator# 2417
state: Colorado
city: Torrington
country: United States
facility: Site Reference ID/Investigator# 5690
state: Connecticut
city: Fort Lauderdale
country: United States
facility: Site Reference ID/Investigator# 2411
state: Florida
city: Lakeland
country: United States
facility: Site Reference ID/Investigator# 3363
state: Florida
city: Port St. Lucie
country: United States
facility: Site Reference ID/Investigator# 3352
state: Florida
city: Atlanta
country: United States
facility: Site Reference ID/Investigator# 3807
state: Georgia
city: Chicago
country: United States
facility: Site Reference ID/Investigator# 3353
state: Illinois
city: Indianapolis
country: United States
facility: Site Reference ID/Investigator# 3359
state: Indiana
city: Baltimore
country: United States
facility: Site Reference ID/Investigator# 2416
state: Maryland
city: Baltimore
country: United States
facility: Site Reference ID/Investigator# 2244
state: Maryland
city: Bethesda
country: United States
facility: Site Reference ID/Investigator# 2401
state: Maryland
city: Peabody
country: United States
facility: Site Reference ID/Investigator# 3793
state: Massachusetts
city: Worcester
country: United States
facility: Site Reference ID/Investigator# 3362
state: Massachusetts
city: Kalamazoo
country: United States
facility: Site Reference ID/Investigator# 2075
state: Michigan
city: Jefferson City
country: United States
facility: Site Reference ID/Investigator# 2418
state: Missouri
city: St. Louis
country: United States
facility: Site Reference ID/Investigator# 4170
state: Missouri
city: Lebanon
country: United States
facility: Site Reference ID/Investigator# 3357
state: New Hampshire
city: Lake Success
country: United States
facility: Site Reference ID/Investigator# 5098
state: New York
city: Huntersville
country: United States
facility: Site Reference ID/Investigator# 2242
state: North Carolina
city: Columbus
country: United States
facility: Site Reference ID/Investigator# 2413
state: Ohio
city: Bethelem
country: United States
facility: Site Reference ID/Investigator# 3354
state: Pennsylvania
city: Philadelphia
country: United States
facility: Site Reference ID/Investigator# 6006
state: Pennsylvania
city: Bristol
country: United States
facility: Site Reference ID/Investigator# 2414
state: Tennessee
city: Tacoma
country: United States
facility: Site Reference ID/Investigator# 2070
state: Washington
city: Brno
country: Czech Republic
facility: Site Reference ID/Investigator# 4687
city: Brno
country: Czech Republic
facility: Site Reference ID/Investigator# 3337
city: Kyjov
country: Czech Republic
facility: Site Reference ID/Investigator# 4278
city: Novy Jicin
country: Czech Republic
facility: Site Reference ID/Investigator# 3328
city: Olomouc
country: Czech Republic
facility: Site Reference ID/Investigator# 3327
city: Ostrava-Poruba
country: Czech Republic
facility: Site Reference ID/Investigator# 3343
city: Prague 2
country: Czech Republic
facility: Site Reference ID/Investigator# 3344
city: Prague 4
country: Czech Republic
facility: Site Reference ID/Investigator# 3342
city: Pribram
country: Czech Republic
facility: Site Reference ID/Investigator# 3411
city: Heraklion
country: Greece
facility: Site Reference ID/Investigator# 3405
city: Thessaloniki
country: Greece
facility: Site Reference ID/Investigator# 3403
city: Thessaloniki
country: Greece
facility: Site Reference ID/Investigator# 3406
city: Budapest
country: Hungary
facility: Site Reference ID/Investigator# 3331
city: Miskolc
country: Hungary
facility: Site Reference ID/Investigator# 3333
city: Szekesfehervar
country: Hungary
facility: Site Reference ID/Investigator# 3332
city: Amsterdam
country: Netherlands
facility: Site Reference ID/Investigator# 3409
city: Eindhoven
country: Netherlands
facility: Site Reference ID/Investigator# 3319
city: Haraderwijk
country: Netherlands
facility: Site Reference ID/Investigator# 3341
city: Hoorn
country: Netherlands
facility: Site Reference ID/Investigator# 3528
city: Bratislava
country: Slovakia
facility: Site Reference ID/Investigator# 3400
city: Martin
country: Slovakia
facility: Site Reference ID/Investigator# 3410
Study officials:
affiliation: AbbVie
name: Gary Gordon, MD
role: STUDY_DIRECTOR
References:
citation: Rudin CM, Mauer A, Smakal M, Juergens R, Spelda S, Wertheim M, Coates A, McKeegan E, Ansell P, Zhou X, Qian J, Pradhan R, Dowell B, Krivoshik A, Gordon G. Phase I/II study of pemetrexed with or without ABT-751 in advanced or metastatic non-small-cell lung cancer. J Clin Oncol. 2011 Mar 10;29(8):1075-82. doi: 10.1200/JCO.2010.32.5944. Epub 2011 Feb 7.