Anti-angiogenesis Agent AG-013736 in Patients with Metastatic Melanoma

This is a Phase 2 study being conducted at multiple centers in the United States. 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.

Official Title

Phase 2 Study of the Anti-angiogenesis Agent AG-013736 in Patients with Metastatic Melanoma

Conditions

– Melanoma- Metastases

Study Type

Interventional

Study Design

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Further Details

Study Start

November 2004

Eligibility & Criteria

Major entry criteria include the following:- 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) – At least 1 site of measurable disease that can be followed for response (i.e., at least 1 target lesion by Response Evaluation Criteria in Solid Tumors) – Have disease that can be biopsied once before and once after treatment – Adequate bone marrow, liver, and kidney function – Must be able to swallow tablets – No evidence of pre-existing, uncontrolled hypertension – No lung lesions located centrally in the chest that involve major blood vessels – No history of hemoptysis (coughing up of blood) – No brain metastases – No prior treatment with anti-angiogenesis agents, including thalidomide or inhibitors or epidermal growth factor (EGF), platelet-derived growth factor (PDGF), or fibroblast growth factor (FGF) receptors

Total Enrolment

60

Contact Details

(US citezens only) Call 734-622-7600 For more information please email ClinicalTrials.gov@Pfizer.com or visit www.Pfizer.com