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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Melanoma

Treatments: Drug: SB-485232

Study type: Interventional

Funder types: Industry

Identifiers

NCT00107718

SB-485232/006

Details and patient eligibility

About

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.

Enrollment: 64 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)