Anti-Angiogenesis Agent AG-013736 In Patients With Metastatic Melanoma

Pfizer

Status and phase: Completed; Phase 2

Conditions: Melanoma; Skin Neoplasms

Treatments: Drug: Axitinib [AG-013736]

Study type: Interventional

Funder types: Industry

Identifiers

NCT00094107

A4061015

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

Axitinib [AG-013736]

Experimental group

Treatment:

Drug: Axitinib [AG-013736]