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

Primary Purpose

Lung Cancer, Non-Small Cell Lung Cancer

Status
Terminated
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
ABT-751
Placebo
Docetaxel
Sponsored by
Abbott
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring Lung Cancer, Non-Small Cell Lung Cancer, NSCLC, ABT-751, docetaxel, Taxotere

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Site Ref # / Investigator 3572
  • Site Ref # / Investigator 4771
  • Site Ref # / Investigator 3574
  • Site Ref # / Investigator 3567
  • Site Ref # / Investigator 3512
  • Site Ref # / Investigator 3565
  • Site Ref # / Investigator 3569
  • Site Ref # / Investigator 3511
  • Site Ref # / Investigator 5237
  • Site Ref # / Investigator 3551
  • Site Ref # / Investigator 3549
  • Site Ref # / Investigator 3571
  • Site Ref # / Investigator 3510
  • Site Ref # / Investigator 3563
  • Site Ref # / Investigator 3559
  • Site Ref # / Investigator 3561
  • Site Ref # / Investigator 3560
  • Site Ref # / Investigator 3562
  • Site Ref # / Investigator 2222
  • Site Ref # / Investigator 3558
  • Site Ref # / Investigator 5097
  • Site Ref # / Investigator 4986
  • Site Ref # / Investigator 4999
  • Site Ref # / Investigator 5158
  • Site Ref # / Investigator 4971
  • Site Ref # / Investigator 5270
  • Site Ref # / Investigator 5259
  • Site Ref # / Investigator 5271
  • Site Ref # / Investigator 5017
  • Site Ref # / Investigator 5274
  • Site Ref # / Investigator 5273
  • Site Ref # / Investigator 5268

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

A

B

Arm Description

Docetaxel + ABT-751

Docetaxel + placebo

Outcomes

Primary Outcome Measures

Progression-free Survival

Secondary Outcome Measures

Overall Survival
Response Rate
Time-to-Progression (TTP)

Full Information

First Posted
July 18, 2006
Last Updated
January 5, 2011
Sponsor
Abbott
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1. Study Identification

Unique Protocol Identification Number
NCT00354562
Brief Title
A Phase 2 Study Evaluating ABT-751 in Combination With Taxotere in Advanced Non-Small Cell Lung Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Terminated
Study Start Date
February 2007 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Abbott

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Non-Small Cell Lung Cancer
Keywords
Lung Cancer, Non-Small Cell Lung Cancer, NSCLC, ABT-751, docetaxel, Taxotere

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
Docetaxel + ABT-751
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
Docetaxel + placebo
Intervention Type
Drug
Intervention Name(s)
ABT-751
Intervention Description
200mg ABT-751 daily for 14 days every 21 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo daily for 14 days every 21 days
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
Taxotere
Intervention Description
Standard Docetaxel every 21 days
Primary Outcome Measure Information:
Title
Progression-free Survival
Time Frame
Subjects may remain on study until disease progression
Secondary Outcome Measure Information:
Title
Overall Survival
Time Frame
Subject may remain on study until disease progression
Title
Response Rate
Time Frame
Subject may remain on study until disease progression
Title
Time-to-Progression (TTP)
Time Frame
Subject may remain on study until disease progression

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helen Eliopoulos, MD
Organizational Affiliation
Abbott
Official's Role
Study Director
Facility Information:
Facility Name
Site Ref # / Investigator 3572
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-3300
Country
United States
Facility Name
Site Ref # / Investigator 4771
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
Site Ref # / Investigator 3574
City
Orange
State/Province
California
ZIP/Postal Code
92868-3298
Country
United States
Facility Name
Site Ref # / Investigator 3567
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
92270
Country
United States
Facility Name
Site Ref # / Investigator 3512
City
Gurnee
State/Province
Illinois
ZIP/Postal Code
60031
Country
United States
Facility Name
Site Ref # / Investigator 3565
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Site Ref # / Investigator 3569
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
Site Ref # / Investigator 3511
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Site Ref # / Investigator 5237
City
Ravenna
State/Province
Ohio
ZIP/Postal Code
44266
Country
United States
Facility Name
Site Ref # / Investigator 3551
City
Crossville
State/Province
Tennessee
ZIP/Postal Code
38555
Country
United States
Facility Name
Site Ref # / Investigator 3549
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Site Ref # / Investigator 3571
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-6307
Country
United States
Facility Name
Site Ref # / Investigator 3510
City
Weston
State/Province
Wisconsin
ZIP/Postal Code
54476
Country
United States
Facility Name
Site Ref # / Investigator 3563
City
Sydney
State/Province
Nova Scotia
ZIP/Postal Code
B1P 1P3
Country
Canada
Facility Name
Site Ref # / Investigator 3559
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 6M2
Country
Canada
Facility Name
Site Ref # / Investigator 3561
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3E 5J1
Country
Canada
Facility Name
Site Ref # / Investigator 3560
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2H1
Country
Canada
Facility Name
Site Ref # / Investigator 3562
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1S6
Country
Canada
Facility Name
Site Ref # / Investigator 2222
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
Site Ref # / Investigator 3558
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4T 7T1
Country
Canada
Facility Name
Site Ref # / Investigator 5097
City
Cork
Country
Ireland
Facility Name
Site Ref # / Investigator 4986
City
Dublin 24
Country
Ireland
Facility Name
Site Ref # / Investigator 4999
City
Dublin 4
Country
Ireland
Facility Name
Site Ref # / Investigator 5158
City
Dublin 7
Country
Ireland
Facility Name
Site Ref # / Investigator 4971
City
Dublin 8
Country
Ireland
Facility Name
Site Ref # / Investigator 5270
City
Barming
ZIP/Postal Code
ME16 9QQ
Country
United Kingdom
Facility Name
Site Ref # / Investigator 5259
City
Belfast
ZIP/Postal Code
BT9 7AB
Country
United Kingdom
Facility Name
Site Ref # / Investigator 5271
City
Edinburgh
ZIP/Postal Code
EH42XU
Country
United Kingdom
Facility Name
Site Ref # / Investigator 5017
City
Glasgow
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
Site Ref # / Investigator 5274
City
Hull
ZIP/Postal Code
HU8 9HE
Country
United Kingdom
Facility Name
Site Ref # / Investigator 5273
City
Surrey
ZIP/Postal Code
GU2 7XX
Country
United Kingdom
Facility Name
Site Ref # / Investigator 5268
City
Surrey
ZIP/Postal Code
SM2 5NG
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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