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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00354562
• Date of registration: 18/07/2006
• Prospective Registration: Yes
• Primary sponsor: Abbott
• Public title: A Phase 2 Study Evaluating ABT-751 in Combination With Taxotere in Advanced Non-Small Cell Lung Cancer
• Scientific title: A Phase 1/2 Study Evaluating the Safety and Efficacy of ABT-751 in Combination With Docetaxel Versus Docetaxel Alone in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer
• Date of first enrolment: February 2007
• Target sample size: 75
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00354562
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 1/Phase 2

Countries of recruitment

Canada, Ireland, Puerto Rico, United Kingdom, United States

Contacts

• Name: Helen Eliopoulos, MD
• Affiliation: Abbott

Key inclusion & exclusion 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 0-2All 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Lung Cancer

Non-Small Cell Lung Cancer

Intervention(s)

Drug: Placebo

Drug: ABT-751

Drug: Docetaxel

Primary Outcome(s)

Progression-free Survival [Time Frame: Subjects may remain on study until disease progression]

Secondary Outcome(s)

Overall Survival [Time Frame: Subject may remain on study until disease progression]

Response Rate [Time Frame: Subject may remain on study until disease progression]

Time-to-Progression (TTP) [Time Frame: Subject may remain on study until disease progression]

Secondary ID(s)

M05-782

2006-002838-38

Source(s) of Monetary Support

Please refer to primary and secondary sponsors