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

Stopped early · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Lung Cancer, Non-Small Cell Lung Cancer

In brief

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

Key facts

Study ID

NCT00354562

Run by

Abbott

People needed

75

Starts

2007-02-01

Last updated by the study team

2011-01-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Site Ref # / Investigator 3572 — Birmingham, Alabama, United States
• Site Ref # / Investigator 4771 — Burbank, California, United States
• Site Ref # / Investigator 3574 — Orange, California, United States
• Site Ref # / Investigator 3567 — Rancho Mirage, California, United States
• Site Ref # / Investigator 3512 — Gurnee, Illinois, United States
• Site Ref # / Investigator 3565 — Hackensack, New Jersey, United States
• Site Ref # / Investigator 3569 — Buffalo, New York, United States
• Site Ref # / Investigator 3511 — Cleveland, Ohio, United States
• Site Ref # / Investigator 5237 — Ravenna, Ohio, United States
• Site Ref # / Investigator 3551 — Crossville, Tennessee, United States
• Site Ref # / Investigator 3549 — Knoxville, Tennessee, United States
• Site Ref # / Investigator 3571 — Nashville, Tennessee, United States
• Site Ref # / Investigator 3510 — Weston, Wisconsin, United States
• Site Ref # / Investigator 3563 — Sydney, Nova Scotia, Canada
• Site Ref # / Investigator 3559 — Barrie, Ontario, Canada
• Site Ref # / Investigator 3561 — Greater Sudbury, Ontario, Canada
• Site Ref # / Investigator 3560 — Greenfield Park, Quebec, Canada
• Site Ref # / Investigator 3562 — Montreal, Quebec, Canada
• Site Ref # / Investigator 2222 — Montreal, Quebec, Canada
• Site Ref # / Investigator 3558 — Regina, Saskatchewan, Canada
• Site Ref # / Investigator 5097 — Cork, Ireland
• Site Ref # / Investigator 4971 — Dublin, Ireland
• Site Ref # / Investigator 4986 — Dublin, Ireland
• Site Ref # / Investigator 4999 — Dublin, Ireland
• Site Ref # / Investigator 5158 — Dublin, Ireland

Full record on ClinicalTrials.gov

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