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

Phase 1

Terminated

• Conditions: Lung Cancer; Non-Small Cell Lung Cancer
• Interventions: Drug: Placebo; Drug: ABT-751; Drug: Docetaxel

• Registration Number: NCT00354562
• Lead Sponsor: Abbott

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-07-18
• Study First Submitted QC: 2006-07-18
• Study First Posted: 2006-07-20
• Study Start: 2007-02
• Primary Completion: 2008-02
• Status Verified: 2010-09
• Last Update Submitted: 2011-01-05
• Last Update Posted: 2011-01-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	Placebo	Docetaxel + placebo
A	Docetaxel	Docetaxel + ABT-751
B	Docetaxel	Docetaxel + placebo
A	ABT-751	Docetaxel + ABT-751

Primary Outcome Measures

Name	Time	Method
Progression-free Survival	Subjects may remain on study until disease progression

Secondary Outcome Measures

Name	Time	Method
Overall Survival	Subject may remain on study until disease progression
Response Rate	Subject may remain on study until disease progression
Time-to-Progression (TTP)	Subject may remain on study until disease progression

Trial Locations

Locations (32)

Site Ref # / Investigator 3571; 🇺🇸 Nashville, Tennessee, United States

Site Ref # / Investigator 5097; 🇮🇪 Cork, Ireland

Site Ref # / Investigator 3563; 🇨🇦 Sydney, Nova Scotia, Canada

Site Ref # / Investigator 2222; 🇨🇦 Montreal, Quebec, Canada

Site Ref # / Investigator 3558; 🇨🇦 Regina, Saskatchewan, Canada

Site Ref # / Investigator 5158; 🇮🇪 Dublin 7, Ireland

Site Ref # / Investigator 5270; 🇬🇧 Barming, United Kingdom

Site Ref # / Investigator 3574; 🇺🇸 Orange, California, United States

Site Ref # / Investigator 4999; 🇮🇪 Dublin 4, Ireland

Site Ref # / Investigator 3511; 🇺🇸 Cleveland, Ohio, United States

Site Ref # / Investigator 3512; 🇺🇸 Gurnee, Illinois, United States

Site Ref # / Investigator 5237; 🇺🇸 Ravenna, Ohio, United States

Site Ref # / Investigator 3572; 🇺🇸 Birmingham, Alabama, United States

Site Ref # / Investigator 3510; 🇺🇸 Weston, Wisconsin, United States

Site Ref # / Investigator 3560; 🇨🇦 Greenfield Park, Quebec, Canada

Site Ref # / Investigator 3565; 🇺🇸 Hackensack, New Jersey, United States

Site Ref # / Investigator 3562; 🇨🇦 Montreal, Quebec, Canada

Site Ref # / Investigator 3551; 🇺🇸 Crossville, Tennessee, United States

Site Ref # / Investigator 3549; 🇺🇸 Knoxville, Tennessee, United States

Site Ref # / Investigator 3569; 🇺🇸 Buffalo, New York, United States

Site Ref # / Investigator 3567; 🇺🇸 Rancho Mirage, California, United States

Site Ref # / Investigator 4771; 🇺🇸 Burbank, California, United States

Site Ref # / Investigator 4986; 🇮🇪 Dublin 24, Ireland

Site Ref # / Investigator 3561; 🇨🇦 Sudbury, Ontario, Canada

Site Ref # / Investigator 5017; 🇬🇧 Glasgow, United Kingdom

Site Ref # / Investigator 4971; 🇮🇪 Dublin 8, Ireland

Site Ref # / Investigator 5271; 🇬🇧 Edinburgh, United Kingdom

Site Ref # / Investigator 5259; 🇬🇧 Belfast, United Kingdom

Site Ref # / Investigator 5273; 🇬🇧 Surrey, United Kingdom

Site Ref # / Investigator 5274; 🇬🇧 Hull, United Kingdom

Site Ref # / Investigator 5268; 🇬🇧 Surrey, United Kingdom

Site Ref # / Investigator 3559; 🇨🇦 Barrie, Ontario, Canada