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

This study has been completed.

Sponsor:

Information provided by:

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00107718

First received: April 7, 2005

Last updated: October 1, 2010

Last verified: October 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

April 7, 2005

Last Updated Date

October 1, 2010

Start Date ^ICMJE

November 2004

Primary Completion Date

May 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Overall response rate of tumor.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00107718 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Progression free survival. Response duration. Time to response. Safety and tolerability. The immune response to SB-485232.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Phase II, Multi-center, Open-label, Randomized Study Evaluating the Anti-tumor Activity of SB-485232, rhIL-18, Administered as Five Daily Intravenous Infusions Every 28 Days in Subjects With Previously Untreated Metastatic Melanoma

Brief Summary

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.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Metastatic Melanoma

Intervention ^ICMJE

Drug: SB-485232

Other Name: SB-485232

Study Arm (s)

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

May 2006

Primary Completion Date

May 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Australia

Administrative Information

NCT Number ^ICMJE

NCT00107718

Other Study ID Numbers ^ICMJE

SB-485232/006, 006

Has Data Monitoring Committee

Responsible Party

Study Director, GSK

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

October 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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