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
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
2006-19-05
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
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Location
GSK Investigational Site
Woolloongabba, Queensland, Australia, 4102
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
Waratah, New South Wales, Australia, 2298
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
East Melbourne, Victoria, Australia, 3002
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
Douglas, Queensland, Australia, 4814
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
Westmead, New South Wales, Australia, 2145
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
Miami Beach, Florida, United States, 33140
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
Hobart, Tasmania, Australia, 7000
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
Los Angeles, California, United States, 90089
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
Jacksonville, Florida, United States, 32209
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
Lutherville Timonium, Maryland, United States, 21093
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
South Brisbane, Queensland, Australia, 4101
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
Chicago, Illinois, United States, 60637
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
Santa Monica, California, United States, 90404-2104
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
Indianapolis, Indiana, United States, 46202
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
New Haven, Connecticut, United States, 06520
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
New York, New York, United States, 10016
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
Nedlands, Western Australia, Australia, 6009
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15213-2584
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
San Francisco, California, United States, 94115
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
Toledo, Ohio, United States, 43614-5809
Status
Terminated/Withdrawn
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Study documents

No study documents available.

Results overview

Results posted on ClinicalTrials.gov

Recruitment status
Completed
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
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