A Phase 1/2 Study Evaluating ABT-751 in Combination With Alimta in Advanced Non-Small Cell Lung Cancer - Full Text View

Purpose

To determine the efficacy of ABT-751 when administered in combination with standard pemetrexed in subjects with advanced or metastatic NSCLC. The Phase 1 portion of the study is complete and the study is currently enrolling subjects in Phase 2.

Condition	Intervention	Phase
Lung Cancer NSCLC Non-Small-Cell Lung Cancer	Drug: ABT-751 Drug: pemetrexed Drug: placebo	Phase 1 Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: 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 Pemetrexed Versus Pemetrexed Alone in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Pemetrexed Pemetrexed disodium

U.S. FDA Resources

Further study details as provided by AbbVie:

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: Subjects may remain on study until disease progression. ] [ Designated as safety issue: No ]
Response Rate [ Time Frame: Subjects may remain on study until disease progression. ] [ Designated as safety issue: No ]
Time-to-Progression (TTP) [ Time Frame: Subjects may remain on study until disease progression. ] [ Designated as safety issue: No ]

Enrollment:	165
Study Start Date:	November 2006
Study Completion Date:	January 2009
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: A Pemetrexed + ABT-751	Drug: ABT-751 200 mg ABT-751 daily for 14 days every 21 days Drug: pemetrexed Standard pemetrexed every 21 days Other Name: Alimta
Placebo Comparator: B Pemetrexed + placebo	Drug: pemetrexed Standard pemetrexed every 21 days Other Name: Alimta Drug: placebo Placebo daily for 14 days 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 0-2
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 than Grade 1 neurological findings
Allergy to sulfa medications
Previous treatment with ABT-751 or pemetrexed
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: NCT00297089

Show 48 Study Locations

Sponsors and Collaborators

AbbVie (prior sponsor, Abbott)

Investigators

Study Director:

Gary Gordon, MD

AbbVie

More Information

No publications provided by AbbVie

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Rudin CM, Mauer A, Smakal M, Juergens R, Spelda S, Wertheim M, Coates A, McKeegan E, Ansell P, Zhou X, Qian J, Pradhan R, Dowell B, Krivoshik A, Gordon G. Phase I/II study of pemetrexed with or without ABT-751 in advanced or metastatic non-small-cell lung cancer. J Clin Oncol. 2011 Mar 10;29(8):1075-82. Epub 2011 Feb 7.

Responsible Party:	AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:	NCT00297089 History of Changes
Other Study ID Numbers:	M05-780, 2006-002830-38
Study First Received:	February 27, 2006
Last Updated:	January 29, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by AbbVie:

Lung Cancer
ABT-751
NSCLC

Alimta
Non-Small-Cell Lung Cancer
pemetrexed

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

Pemetrexed
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on May 16, 2013