Anti-Angiogenesis Agent AG-013736 In Patients With Metastatic Melanoma - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00094107

Purpose

This is a Phase 2 study being conducted at multiple centers in the United States and France. Patients having melanoma that has spread to other parts of the body (i.e., metastatic) are eligible to participate. Patients must have disease that has been treated with no more than 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 metastatic melanoma as shown by the number of patients in the study who experience significant and durable tumor shrinkage.

Condition	Intervention	Phase
Melanoma Skin Neoplasms	Drug: VEGFR and PDGFR inhibitor, AG-013736, Axitinib	Phase II

MedlinePlus related topics: Cancer Melanoma Skin Cancer

Drug Information available for: Axitinib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase 2 Study Of The Anti-Angiogenesis Agent AG-013736 In Patients With Metastatic Melanoma

Further study details as provided by Pfizer:

Primary Outcome Measures:

To determine response rate of AG 013736 in patients with metastatic melanoma as measured by the overall response rate, complete response (CR) and partial response (PR) by RECIST. [ Time Frame: April 2008 ] [ Designated as safety issue: No ]
Time to completion is estimated at 12 months. [ Time Frame: at 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

determine overall survival [ Time Frame: March 2008 ] [ Designated as safety issue: No ]
population pharmacokinetic analyses [ Time Frame: March 2008 ] [ Designated as safety issue: No ]
explore relationships between clinical response [ Time Frame: March 2008 ] [ Designated as safety issue: No ]
determine the safety profile of AG 013736 [ Time Frame: March 2008 ] [ Designated as safety issue: No ]
determine progression-free survival (PFS) [ Time Frame: March 2008 ] [ Designated as safety issue: No ]
determine duration of response [ Time Frame: March 2008 ] [ Designated as safety issue: No ]

Enrollment:	32
Study Start Date:	December 2004
Study Completion Date:	April 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: VEGFR and PDGFR inhibitor, AG-013736, Axitinib single agent AG-013736 starting dose 5 mg BID +/- 20% according to toxicity. Treatment until progression or unacceptable toxicity occurs.

Eligibility

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

Criteria

Inclusion Criteria:

Histologically documented melanoma with metastases
No more than 1 prior systemic therapy for metastatic disease (prior adjuvant therapy with interferon does not count as prior therapy for metastatic disease)

Exclusion Criteria:

History of hemoptysis (coughing up of blood)
Brain metastases

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00094107

Locations

United States, California
Pfizer Investigational Site
Orange, California, United States, 92868
United States, Florida
Pfizer Investigational Site
Aventura, Florida, United States, 33180
Pfizer Investigational Site
MIAMI BEACH, Florida, United States, 33140
Pfizer Investigational Site
Miami Beach, Florida, United States, 33140
United States, Massachusetts
Pfizer Investigational Site
Boston, Massachusetts, United States, 02115
Pfizer Investigational Site
Boston, Massachusetts, United States, 02215
United States, Pennsylvania
Pfizer Investigational Site
Pittsburgh, Pennsylvania, United States, 15232
Pfizer Investigational Site
Pittsburgh, Pennsylvania, United States, 15232-1305
France
Pfizer Investigational Site
Paris Cedex 13, France, 75651

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

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A4061015
Study First Received:	October 11, 2004
Last Updated:	September 25, 2008
ClinicalTrials.gov Identifier:	NCT00094107
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

melanoma, antiangiogenesis

Study placed in the following topic categories:

Neuroectodermal Tumors
Skin Diseases
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma

Nevus
Skin Neoplasms
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on January 16, 2009