Last updated: 11/04/2018 11:31:59

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

GSK study ID
SB-485232/006
Clinicaltrials.gov ID
NCT00107718
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Phase II study of IL-18 in melanoma patients
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Overall response rate

Timeframe: Up to 6 months

Secondary outcomes:

Progression free survival

Timeframe: Up to 6 months

Duration of Response

Timeframe: Up to 6 months

Time to response

Timeframe: Up to 6 months

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

Timeframe: Up to 6 months

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

Timeframe: Baseline (Day 1) to Day 15 and Follow up (Day 28) of each cycle

Number of participants with toxicity grade shift of clinical laboratory parameters over period

Timeframe: Baselie (Cycle1,Day 1), Day 2, Day 15 and Follow up (28 days after last dose of Cycle 13) of each cycle

Number of participants with immune response to SB485232 over period

Timeframe: Day 15 of each cycle upto Cycle 13

Interventions:
  • Drug: SB-485232
    • Enrollment:
    64
    Primary completion date:
    2006-19-05
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Melanoma
    Product
    iboctadekin
    Collaborators
    Not applicable
    Study date(s)
    November 2004 to May 2006
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • 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.
    • Patients having hepatitis or HIV infection.
    • Taking corticosteroids.
    Inclusion and exclusion criteria
    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 location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Woolloongabba, Queensland, Australia, 4102
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Waratah, New South Wales, Australia, 2298
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    East Melbourne, Victoria, Australia, 3002
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Douglas, Queensland, Australia, 4814
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Westmead, New South Wales, Australia, 2145
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Miami Beach, Florida, United States, 33140
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Hobart, Tasmania, Australia, 7000
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Los Angeles, California, United States, 90089
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Jacksonville, Florida, United States, 32209
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Lutherville Timonium, Maryland, United States, 21093
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    South Brisbane, Queensland, Australia, 4101
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Chicago, Illinois, United States, 60637
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Santa Monica, California, United States, 90404-2104
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Indianapolis, Indiana, United States, 46202
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    New Haven, Connecticut, United States, 06520
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    New York, New York, United States, 10016
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Nedlands, Western Australia, Australia, 6009
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Pittsburgh, Pennsylvania, United States, 15213-2584
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    San Francisco, California, United States, 94115
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Toledo, Ohio, United States, 43614-5809
    Status
    Terminated/Withdrawn
    Contact us

    Study documents

    No study documents available.

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2006-19-05
    Actual study completion date
    2006-19-05

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
    Participate in clinical trial
    Access to clinical trial data by researchers
    Visit website