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

• Progression-free Survival
• Maximum Tolerated Dose

• Overall Survival [ Time Frame: Subject may remain on study until disease progression ] [ Designated as safety issue: No ]
• Response Rate [ Time Frame: Subject may remain on study until disease progression ] [ Designated as safety issue: No ]
• Time-to-Progression (TTP) [ Time Frame: Subject may remain on study until disease progression ] [ Designated as safety issue: No ]

• Overall survival
• Response rate
• Duration of response
• Time-to-Progression (TTP)
• Quality of Life (QoL)
• Treatment related toxicities

To determine the efficacy of ABT-751 when administered in combination with standard docetaxel in subjects with advanced or metastatic NSCLC.

• Lung Cancer
• Non-Small Cell Lung Cancer

• Drug: ABT-751
  200mg ABT-751 daily for 14 days every 21 days
  Other Name: ABT-751
• Drug: Placebo
  Placebo daily for 14 days every 21 days
  Other Name: placebo
• Drug: Docetaxel
  Standard Docetaxel every 21 days
  Other Names:

  • Docetaxel
  • Taxotere

• Active Comparator: A
  Docetaxel + ABT-751
  Interventions:

  • Drug: ABT-751
  • Drug: Docetaxel
• Placebo Comparator: B
  Docetaxel + placebo
  Interventions:

  • Drug: Placebo
  • Drug: Docetaxel

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 0-2All anti-tumor therapy discontinued at least 3 weeks prior to study entryAll adverse events from prior treatment are resolved or stableAdequate hematologic, renal, and hepatic functionFemales must not be pregnantWilling to take adequate measures to prevent pregnancyLife expectancy of at least 3 monthsAble to complete the Quality of Life questionnaireVoluntarily signed informed consent

• 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 that Grade 1 neurological findings
• Allergy to sulfa medications
• Previous treatment with ABT-751 or docetaxel
• 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