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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00107718
Registration number
NCT00107718
Ethics application status
Date submitted
7/04/2005
Date registered
8/04/2005
Date last updated
27/07/2017
Titles & IDs
Public title
Anti-Tumor Activity Of SB-485232 In Patients With Previously Untreated Metastatic Melanoma
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Scientific title
A Phase II Study of IL-18 in Melanoma Patients
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Secondary ID [1]
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SB-485232/006
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Melanoma
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Condition category
Condition code
Cancer
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Malignant melanoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - SB-485232
Treatment: Drugs: SB-485232
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overall response rate of tumor
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Assessment method [1]
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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.
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Timepoint [1]
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Up to 12 months
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Secondary outcome [1]
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Number of participants with progression free survival
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Assessment method [1]
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Progression Free Survival is defined as the time from the start of treatment until the first documented sign of disease progression or death due to any cause, whichever occurred first. For participants who did not progress or die, progression free survival was censored at the time of initiation of alternative anti-cancer therapy or time of last contact, whichever occurred first. The times to progression were summarized using the Kaplan-Meier survival curve.
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Timepoint [1]
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Up to 12 months
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Secondary outcome [2]
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Response duration of SB-485232 for tumor treatment
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Assessment method [2]
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Response duration defined as the date criteria for Complete Response (CR) or Partial Response (PR) (whichever occured first) was first met until the date criteria for recurrent or progressive disease was first met or death due to any cause was reported, whichever occured first. Time to response was defined as the date study drug was first dosed until the date criteria for CR or PR (whichever occured first) was first met.
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Timepoint [2]
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Up to 12 months
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Secondary outcome [3]
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Time to response
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Assessment method [3]
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Response duration defined as the date criteria for CR or PR (whichever occured first) was first met until the date criteria for recurrent or progressive disease was first met or death due to any cause was reported, whichever occured first. Time to response was defined as the date study drug was first dosed until the date criteria for CR or PR (whichever occured first) was first met.
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Timepoint [3]
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Up to 12 months
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Secondary outcome [4]
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Number of participants with adverse events (AEs), serious adverse events (SAEs), and death.
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Assessment method [4]
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An AE is any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect.
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Timepoint [4]
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Up to 12 months
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Secondary outcome [5]
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Change from Baseline In vital signs [systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR), and body temperature(BT)]
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Assessment method [5]
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Vital signs including SBP, DBP, HR and BT were taken at Day 1 to Day 15 and follow up visits of each cycle. Baseline assessment was performed pre-dose on Cycle 1 Day 1.
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Timepoint [5]
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Baseline (Day 1) to Day 15 and Day 28 of each cycle
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Secondary outcome [6]
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Number of participants with toxicity grade shift of clinical laboratory parameters over period.
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Assessment method [6]
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Haematology and Clinical Chemistry together are termed as Clinical Laboratory Parameters.Blood samples were collected at Day 1, Day 2, Day 15 and Follow up of each cycle for assessment of clinical chemistry and haematology parameters. Sodium, Potassium, Chloride, Bicarbonate, Calcium, Glucose, Total protein, Albumin, Lactate dehydrogenase, Uric acid, Phosphorus, Creatinine, Blood urea nitrogen, Total bilirubin, Alkaline phosphatase, Aspartate aminotransferase (AST), Alanine aminotransferase (ALT) and Magnesium were analyzed in clinical chemistry. Similarly, Hemoglobin, Hematocrit, Platelet count, Total white blood cell count, Neutrophil count, Lymphocyte count, Monocyte count, Eosinophil count and Basophil count wee analyzed in haematology. Number of participants with shift of grades from Baseline in hematology and clinical chemistry parameters toxicities have been summarized here.
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Timepoint [6]
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Baselie (Cycle1,Day 1), Day 2, Day 15 and Follow up (28 days after last dose of Cycle 13) of each cycle
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Secondary outcome [7]
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Number of participants with immune response to SB485232 over period.
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Assessment method [7]
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Immunotherapy for melanoma is based on the premise that the immune system can recognize and attack host tumor cells. This may be achieved by either triggering an immune response or by potentiating an otherwise weak immune response that is capable of recognizing the participant's own tumor. Various dosing schedules and combinations involving IFN-a and interleukin (IL)-2 have been tested. The response rate reported with single agent IL-2, as well as for combinations with Interferon-a, range from a low of 3% (as single agent) to a high of 41% (for the combination), with a small percentage of long term responders. The immune response to SB-485232 was assessed by measuring the anti-SB-485232 levels (total immunoglobulin and immunoglobulin E [IgE]) before starting therapy and at specified time points, throughout the study period.
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Timepoint [7]
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Day 15 of each cycle
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Eligibility
Key inclusion 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
15/11/2004
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
19/05/2006
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Sample size
Target
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Accrual to date
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Final
64
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,TAS,VIC,WA
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Recruitment hospital [1]
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GSK Investigational Site - Waratah
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Recruitment hospital [2]
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GSK Investigational Site - Westmead
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Recruitment hospital [3]
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GSK Investigational Site - Douglas
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Recruitment hospital [4]
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GSK Investigational Site - South Brisbane
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Recruitment hospital [5]
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GSK Investigational Site - Woolloongabba
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Recruitment hospital [6]
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GSK Investigational Site - Hobart
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Recruitment hospital [7]
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GSK Investigational Site - East Melbourne
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Recruitment hospital [8]
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GSK Investigational Site - Nedlands
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Recruitment postcode(s) [1]
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2298 - Waratah
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Recruitment postcode(s) [2]
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2145 - Westmead
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Recruitment postcode(s) [3]
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4814 - Douglas
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Recruitment postcode(s) [4]
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4101 - South Brisbane
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Recruitment postcode(s) [5]
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4102 - Woolloongabba
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Recruitment postcode(s) [6]
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7000 - Hobart
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Recruitment postcode(s) [7]
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3002 - East Melbourne
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Recruitment postcode(s) [8]
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6009 - Nedlands
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Connecticut
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Country [3]
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United States of America
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State/province [3]
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Florida
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Country [4]
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United States of America
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State/province [4]
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Illinois
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Country [5]
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United States of America
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State/province [5]
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Indiana
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Country [6]
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United States of America
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State/province [6]
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Maryland
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Country [7]
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United States of America
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State/province [7]
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New York
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Country [8]
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United States of America
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State/province [8]
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Ohio
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Country [9]
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United States of America
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State/province [9]
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Pennsylvania
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
GlaxoSmithKline
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00107718
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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GSK Clinical Trials
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Address
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GlaxoSmithKline
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00107718
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