Anti-Angiogenesis Agent AG-013736 in Patients With Advanced Non-Small Cell Lung Cancer - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00094094

Purpose

This is a Phase 2 study being conducted at multiple centers in the United States and Germany. Patients having non-small cell lung cancer that has spread to other parts of the body (i.e., metastatic) or is locally advanced (i.e., Stage IIIB with malignant pleural effusion) are eligible to participate. Patients must have disease that has been treated with at least 1 prior treatment for metastatic disease (prior adjuvant treatment for localized disease does not count as prior treatment for metastatic disease). The purpose of the study is to test whether the angiogenesis inhibitor AG-013736 is an effective treatment for advanced non-small cell lung cancer as shown by the number of patients in the study who experience significant and durable tumor shrinkage

Condition	Intervention	Phase
Lung Neoplasms Carcinoma, Non-Small Cell Lung	Drug: VEGFR and PDGFR inhibitor	Phase II

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Axitinib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase 2 Study of the Anti-Angiogenesis Agent AG-013736 as Second- or Later- Line Treatment in Patients With Advanced Non-Small Cell Lung Cancer

Further study details as provided by Pfizer:

Primary Outcome Measures:

Response rate of AG 013736 in patients with advanced non-small cell lung cancer as measured by the overall response rate, complete response (CR) and partial response (PR) by RECIST
Time to completion is estimated at 12 months.

Secondary Outcome Measures:

Determine the safety profile of AG 013736
Determine progression-free survival (PFS)
Determine duration of response
Determine overall survival, population pharmacokinetic analyses
Explore relationships between clinical response and plasma soluble proteins

Enrollment:	32
Study Start Date:	February 2005
Study Completion Date:	July 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically documented non-small cell lung cancer with metastases (Stage IV or recurrent disease) or locally advanced (Stage IIIB) with malignant pleural effusion.
At least 1 prior systemic therapy for metastatic disease (Prior adjuvant therapy for localized disease does not count as a prior therapy for metastatic disease).

Exclusion Criteria:

Central lung lesions involving major blood vessels (arteries or veins). (Central lesions that maintain the structural integrity of vessels have the potential to bleed if the tumor lesion undergoes necrosis. MRI or CT angiography should be used in any case where there is any question as to whether blood vessels are involved.)
Patients with a history of Grade 2 or worse hemoptysis are not eligible. Patients with a history of Grade 1 hemoptysis within 30 days of entry are not eligible

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00094094

Locations

United States, California
Pfizer Investigational Site
Irvine, California, United States, 92612
Pfizer Investigational Site
Orange, California, United States, 92868
United States, Illinois
Pfizer Investigational Site
Chicago, Illinois, United States, 60637
Pfizer Investigational Site
Park Ridge, Illinois, United States, 60068
United States, Minnesota
Pfizer Investigational Site
Coon Rapids, Minnesota, United States, 55433
Pfizer Investigational Site
Fridley, Minnesota, United States, 55432
Pfizer Investigational Site
Robbinsdale, Minnesota, United States, 55422
United States, North Carolina
Pfizer Investigational Site
Charlotte, North Carolina, United States, 28203
United States, Tennessee
Pfizer Investigational Site
Nashville, Tennessee, United States, 37232
United States, Wisconsin
Pfizer Investigational Site
Madison, Wisconsin, United States, 53792
Germany
Pfizer Investigational Site
Gauting, Germany, 82131

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Study ID Numbers:	A4061011
Study First Received:	October 11, 2004
Last Updated:	November 7, 2008
ClinicalTrials.gov Identifier:	NCT00094094
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

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

ClinicalTrials.gov processed this record on January 16, 2009