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

Sponsored by:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00354562

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 I Phase II

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Docetaxel ABT 751 E 7010

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment
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

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:	79
Study Start Date:	June 2006
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator Docetaxel + ABT-751	Drug: ABT-751 200mg ABT-751 daily for 14 days every 21 days Drug: Docetaxel Standard Docetaxel every 21 days
B: Placebo Comparator Docetaxel + placebo	Drug: Placebo Placebo daily for 14 days every 21 days Drug: Docetaxel Standard Docetaxel every 21 days

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

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

Show 55 Study Locations

Sponsors and Collaborators

Abbott

Investigators

Study Director:

Helen Eliopoulos, MD

Abbott

More Information

Responsible Party:	Abbott ( Helen Eliopoulos, MD, Global Project Head )
Study ID Numbers:	M05-782
Study First Received:	July 18, 2006
Last Updated:	March 9, 2008
ClinicalTrials.gov Identifier:	NCT00354562
Health Authority:	United States: Food and Drug Administration

Keywords provided by Abbott:

Lung Cancer
Non-Small Cell Lung Cancer
NSCLC

ABT-751
docetaxel
Taxotere

Study placed in the following topic categories:

Docetaxel
Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms

Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009