NCT00107718

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2004

Shorter than P25 for phase_2

Geographic Reach
2 countries

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2004

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 8, 2005

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 19, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 19, 2006

Completed
Last Updated

July 27, 2017

Status Verified

July 1, 2017

Enrollment Period

1.5 years

First QC Date

April 7, 2005

Last Update Submit

July 25, 2017

Conditions

Melanoma

Keywords

IL-18treatment naivePhase 2melanoma

Outcome Measures

Primary Outcomes (1)

  • Overall response rate of tumor

    Tumor response rate (RR) is defined as the percentage of participants achieving either a complete or partial response. Response was at least one measurable lesion as defined by response evaluation criteria for solid tumors (RECIST) criteria or a cutaneous or subcutaneous lesion of at least 1 centimeter (cm) in diameter in one dimension. A distinction was drawn between responses that are confirmed at a repeat assessment and those that are not. If there were unconfirmed responses, then a sensitivity analysis was performed excluding participants with unconfirmed responses. Analysis was performed by both Investigator and independent review committee (IRC). The results were compared and a confirmatory analysis has been presented.

    Up to 12 months

Secondary Outcomes (7)

  • Number of participants with progression free survival

    Up to 12 months

  • Response duration of SB-485232 for tumor treatment

    Up to 12 months

  • Time to response

    Up to 12 months

  • Number of participants with adverse events (AEs), serious adverse events (SAEs), and death.

    Up to 12 months

  • Change from Baseline In vital signs [systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR), and body temperature(BT)]

    Baseline (Day 1) to Day 15 and Day 28 of each cycle

  • +2 more secondary outcomes

Interventions

SB-485232DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

GSK Investigational Site

Los Angeles, California, 90089, United States

Location

GSK Investigational Site

San Francisco, California, 94115, United States

Location

GSK Investigational Site

Santa Monica, California, 90404-2104, United States

Location

GSK Investigational Site

New Haven, Connecticut, 06520, United States

Location

GSK Investigational Site

Jacksonville, Florida, 32209, United States

Location

GSK Investigational Site

Miami Beach, Florida, 33140, United States

Location

GSK Investigational Site

Chicago, Illinois, 60637, United States

Location

GSK Investigational Site

Indianapolis, Indiana, 46202, United States

Location

GSK Investigational Site

Lutherville-Timonium, Maryland, 21093, United States

Location

GSK Investigational Site

New York, New York, 10016, United States

Location

GSK Investigational Site

Toledo, Ohio, 43614-5809, United States

Location

GSK Investigational Site

Pittsburgh, Pennsylvania, 15213-2584, United States

Location

GSK Investigational Site

Waratah, New South Wales, 2298, Australia

Location

GSK Investigational Site

Westmead, New South Wales, 2145, Australia

Location

GSK Investigational Site

Douglas, Queensland, 4814, Australia

Location

GSK Investigational Site

South Brisbane, Queensland, 4101, Australia

Location

GSK Investigational Site

Woolloongabba, Queensland, 4102, Australia

Location

GSK Investigational Site

Hobart, Tasmania, 7000, Australia

Location

GSK Investigational Site

East Melbourne, Victoria, 3002, Australia

Location

GSK Investigational Site

Nedlands, Western Australia, 6009, Australia

Location

MeSH Terms

Conditions

Melanoma

Interventions

Interleukin-18

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

InterleukinsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2005

First Posted

April 8, 2005

Study Start

November 15, 2004

Primary Completion

May 19, 2006

Study Completion

May 19, 2006

Last Updated

July 27, 2017

Record last verified: 2017-07

Locations

US(12)AU(8)