Anti-Tumor Activity Of SB-485232 In Patients With Previously Untreated Metastatic Melanoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-15

Study Completion Date

2006-05-19

Brief Summary

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This Phase II study is designed to evaluate the anti-tumor activity of three dose groups of SB-485232 (0.01, 0.1, and 1.0 mg/kg/day) administered intravenously as a single agent in subjects with previously untreated metastatic melanoma.

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Detailed Description

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Conditions

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Melanoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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SB-485232

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients must have melanoma that has spread beyond the original location and has not yet been treated.
* Tissue from the spreading melanoma should have been tested to confirm it is melanoma.

Exclusion Criteria

* Patients having hepatitis or HIV infection.
* Taking corticosteroids.
* Patients with the primary site being occular melanoma or patients with melanoma of the brain.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No