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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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Cancer, NSCLC, Non-Small-Cell Lung Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Progression-free Survival

Outcome Time Frame:

Subjects may remain on study until disease progression.

Safety Issue:

No

Principal Investigator

Gary Gordon, MD

Investigator Role:

Study Director

Investigator Affiliation:

AbbVie

Authority:

United States: Food and Drug Administration

Study ID:

M05-780

NCT ID:

NCT00297089

Start Date:

November 2006

Completion Date:

January 2009

Related Keywords:

  • Lung Cancer
  • NSCLC
  • Non-Small-Cell Lung Cancer
  • Lung Cancer
  • ABT-751
  • NSCLC
  • Alimta
  • Non-Small-Cell Lung Cancer
  • pemetrexed
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Site Reference ID/Investigator# 3358Fayetteville, Arkansas  72703
Site Reference ID/Investigator# 4102Hot Springs, Arkansas  71913
Site Reference ID/Investigator# 2127Greenbrae, California  94904
Site Reference ID/Investigator# 2417Fort Collins, Colorado  80524
Site Reference ID/Investigator# 5690Torrington, Connecticut  06790
Site Reference ID/Investigator# 2411Fort Lauderdale, Florida  33316
Site Reference ID/Investigator# 3363Lakeland, Florida  33805
Site Reference ID/Investigator# 3352Port St. Lucie, Florida  34952
Site Reference ID/Investigator# 3807Atlanta, Georgia  30309
Site Reference ID/Investigator# 3353Chicago, Illinois  60637
Site Reference ID/Investigator# 3359Indianapolis, Indiana  46256
Site Reference ID/Investigator# 2244Baltimore, Maryland  21231-1000
Site Reference ID/Investigator# 2416Baltimore, Maryland  21229
Site Reference ID/Investigator# 2401Bethesda, Maryland  20817
Site Reference ID/Investigator# 3793Peabody, Massachusetts  01960
Site Reference ID/Investigator# 3362Worcester, Massachusetts  01608
Site Reference ID/Investigator# 2075Kalamazoo, Michigan  49048
Site Reference ID/Investigator# 2418Jefferson City, Missouri  65109
Site Reference ID/Investigator# 4170St. Louis, Missouri  63110-0250
Site Reference ID/Investigator# 3357Lebanon, New Hampshire  03756
Site Reference ID/Investigator# 5098Lake Success, New York  11042
Site Reference ID/Investigator# 2242Huntersville, North Carolina  28078
Site Reference ID/Investigator# 2413Columbus, Ohio  43235
Site Reference ID/Investigator# 3354Bethelem, Pennsylvania  18015
Site Reference ID/Investigator# 6006Philadelphia, Pennsylvania  19141
Site Reference ID/Investigator# 2414Bristol, Tennessee  37620
Site Reference ID/Investigator# 2070Tacoma, Washington  98405