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

Lung Cancer Clinical Trial

Official 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00354562
• Other study ID #: M05-782
• Secondary ID: 2006-002838-38
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: July 18, 2006
• Last updated: January 5, 2011
• Start date: February 2007

Study information

• Verified date: September 2010
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 75
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

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

Locations

Country	Name	City	State
Canada	Site Ref # / Investigator 3559	Barrie	Ontario
Canada	Site Ref # / Investigator 3560	Greenfield Park	Quebec
Canada	Site Ref # / Investigator 2222	Montreal	Quebec
Canada	Site Ref # / Investigator 3562	Montreal	Quebec
Canada	Site Ref # / Investigator 3558	Regina	Saskatchewan
Canada	Site Ref # / Investigator 3561	Sudbury	Ontario
Canada	Site Ref # / Investigator 3563	Sydney	Nova Scotia
Ireland	Site Ref # / Investigator 5097	Cork
Ireland	Site Ref # / Investigator 4986	Dublin 24
Ireland	Site Ref # / Investigator 4999	Dublin 4
Ireland	Site Ref # / Investigator 5158	Dublin 7
Ireland	Site Ref # / Investigator 4971	Dublin 8
United Kingdom	Site Ref # / Investigator 5270	Barming
United Kingdom	Site Ref # / Investigator 5259	Belfast
United Kingdom	Site Ref # / Investigator 5271	Edinburgh
United Kingdom	Site Ref # / Investigator 5017	Glasgow
United Kingdom	Site Ref # / Investigator 5274	Hull
United Kingdom	Site Ref # / Investigator 5268	Surrey
United Kingdom	Site Ref # / Investigator 5273	Surrey
United States	Site Ref # / Investigator 3572	Birmingham	Alabama
United States	Site Ref # / Investigator 3569	Buffalo	New York
United States	Site Ref # / Investigator 4771	Burbank	California
United States	Site Ref # / Investigator 3511	Cleveland	Ohio
United States	Site Ref # / Investigator 3551	Crossville	Tennessee
United States	Site Ref # / Investigator 3512	Gurnee	Illinois
United States	Site Ref # / Investigator 3565	Hackensack	New Jersey
United States	Site Ref # / Investigator 3549	Knoxville	Tennessee
United States	Site Ref # / Investigator 3571	Nashville	Tennessee
United States	Site Ref # / Investigator 3574	Orange	California
United States	Site Ref # / Investigator 3567	Rancho Mirage	California
United States	Site Ref # / Investigator 5237	Ravenna	Ohio
United States	Site Ref # / Investigator 3510	Weston	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Countries where clinical trial is conducted

United States,  Canada,  Ireland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free Survival		Subjects may remain on study until disease progression	No
Secondary	Overall Survival		Subject may remain on study until disease progression	No
Secondary	Response Rate		Subject may remain on study until disease progression	No
Secondary	Time-to-Progression (TTP)		Subject may remain on study until disease progression	No