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

This study has been terminated.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00354562
First received: July 18, 2006
Last updated: January 5, 2011
Last verified: September 2010
  Purpose

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


Condition Intervention Phase
Lung Cancer
Non-Small Cell Lung Cancer
Drug: ABT-751
Drug: Placebo
Drug: Docetaxel
Phase 1
Phase 2

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
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

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Progression-free Survival [ Time Frame: Subjects may remain on study until disease progression ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall Survival [ Time Frame: Subject may remain on study until disease progression ] [ Designated as safety issue: No ]
  • Response Rate [ Time Frame: Subject may remain on study until disease progression ] [ Designated as safety issue: No ]
  • Time-to-Progression (TTP) [ Time Frame: Subject may remain on study until disease progression ] [ Designated as safety issue: No ]

Enrollment: 75
Study Start Date: February 2007
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Docetaxel + ABT-751
Drug: ABT-751
200mg ABT-751 daily for 14 days every 21 days
Other Name: ABT-751
Drug: Docetaxel
Standard Docetaxel every 21 days
Other Names:
  • Docetaxel
  • Taxotere
Placebo Comparator: B
Docetaxel + placebo
Drug: Placebo
Placebo daily for 14 days every 21 days
Other Name: placebo
Drug: Docetaxel
Standard Docetaxel every 21 days
Other Names:
  • Docetaxel
  • Taxotere

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00354562

  Hide Study Locations
Locations
United States, Alabama
Site Ref # / Investigator 3572
Birmingham, Alabama, United States, 35294-3300
United States, California
Site Ref # / Investigator 4771
Burbank, California, United States, 91505
Site Ref # / Investigator 3574
Orange, California, United States, 92868-3298
Site Ref # / Investigator 3567
Rancho Mirage, California, United States, 92270
United States, Illinois
Site Ref # / Investigator 3512
Gurnee, Illinois, United States, 60031
United States, New Jersey
Site Ref # / Investigator 3565
Hackensack, New Jersey, United States, 07601
United States, New York
Site Ref # / Investigator 3569
Buffalo, New York, United States, 14215
United States, Ohio
Site Ref # / Investigator 3511
Cleveland, Ohio, United States, 44195
Site Ref # / Investigator 5237
Ravenna, Ohio, United States, 44266
United States, Tennessee
Site Ref # / Investigator 3551
Crossville, Tennessee, United States, 38555
Site Ref # / Investigator 3549
Knoxville, Tennessee, United States, 37920
Site Ref # / Investigator 3571
Nashville, Tennessee, United States, 37232-6307
United States, Wisconsin
Site Ref # / Investigator 3510
Weston, Wisconsin, United States, 54476
Canada, Nova Scotia
Site Ref # / Investigator 3563
Sydney, Nova Scotia, Canada, B1P 1P3
Canada, Ontario
Site Ref # / Investigator 3559
Barrie, Ontario, Canada, L4M 6M2
Site Ref # / Investigator 3561
Sudbury, Ontario, Canada, P3E 5J1
Canada, Quebec
Site Ref # / Investigator 3560
Greenfield Park, Quebec, Canada, J4V 2H1
Site Ref # / Investigator 3562
Montreal, Quebec, Canada, H2W 1S6
Site Ref # / Investigator 2222
Montreal, Quebec, Canada, H3T 1E2
Canada, Saskatchewan
Site Ref # / Investigator 3558
Regina, Saskatchewan, Canada, S4T 7T1
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, Ireland
United Kingdom
Site Ref # / Investigator 5270
Barming, United Kingdom, ME16 9QQ
Site Ref # / Investigator 5259
Belfast, United Kingdom, BT9 7AB
Site Ref # / Investigator 5271
Edinburgh, United Kingdom, EH42XU
Site Ref # / Investigator 5017
Glasgow, United Kingdom, G12 0YN
Site Ref # / Investigator 5274
Hull, United Kingdom, HU8 9HE
Site Ref # / Investigator 5273
Surrey, United Kingdom, GU2 7XX
Site Ref # / Investigator 5268
Surrey, United Kingdom, SM2 5NG
Sponsors and Collaborators
Abbott
Investigators
Study Director: Helen Eliopoulos, MD Abbott
  More Information

No publications provided

Responsible Party: Helen Eliopoulos, MD, Global Project Head, Abbott
ClinicalTrials.gov Identifier: NCT00354562     History of Changes
Other Study ID Numbers: M05-782, 2006-002838-38
Study First Received: July 18, 2006
Last Updated: January 5, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott:
Lung Cancer
Non-Small Cell Lung Cancer
NSCLC
ABT-751
docetaxel
Taxotere

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 26, 2014