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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
A Phase II Study of IL-18 in Melanoma Patients
Secondary ID [1] 0 0
SB-485232/006
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Melanoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall response rate of tumor
Timepoint [1] 0 0
Up to 12 months
Secondary outcome [1] 0 0
Number of participants with progression free survival
Timepoint [1] 0 0
Up to 12 months
Secondary outcome [2] 0 0
Response duration of SB-485232 for tumor treatment
Timepoint [2] 0 0
Up to 12 months
Secondary outcome [3] 0 0
Time to response
Timepoint [3] 0 0
Up to 12 months
Secondary outcome [4] 0 0
Number of participants with adverse events (AEs), serious adverse events (SAEs), and death.
Timepoint [4] 0 0
Up to 12 months
Secondary outcome [5] 0 0
Change from Baseline In vital signs [systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR), and body temperature(BT)]
Timepoint [5] 0 0
Baseline (Day 1) to Day 15 and Day 28 of each cycle
Secondary outcome [6] 0 0
Number of participants with toxicity grade shift of clinical laboratory parameters over period.
Timepoint [6] 0 0
Baselie (Cycle1,Day 1), Day 2, Day 15 and Follow up (28 days after last dose of Cycle 13) of each cycle
Secondary outcome [7] 0 0
Number of participants with immune response to SB485232 over period.
Timepoint [7] 0 0
Day 15 of each cycle

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/11/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/05/2006
Sample size
Target
Accrual to date
Final
64
Recruitment in Australia
Recruitment state(s)
NSW,QLD,TAS,VIC,WA
Recruitment hospital [1] 0 0
GSK Investigational Site - Waratah
Recruitment hospital [2] 0 0
GSK Investigational Site - Westmead
Recruitment hospital [3] 0 0
GSK Investigational Site - Douglas
Recruitment hospital [4] 0 0
GSK Investigational Site - South Brisbane
Recruitment hospital [5] 0 0
GSK Investigational Site - Woolloongabba
Recruitment hospital [6] 0 0
GSK Investigational Site - Hobart
Recruitment hospital [7] 0 0
GSK Investigational Site - East Melbourne
Recruitment hospital [8] 0 0
GSK Investigational Site - Nedlands
Recruitment postcode(s) [1] 0 0
2298 - Waratah
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4814 - Douglas
Recruitment postcode(s) [4] 0 0
4101 - South Brisbane
Recruitment postcode(s) [5] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [6] 0 0
7000 - Hobart
Recruitment postcode(s) [7] 0 0
3002 - East Melbourne
Recruitment postcode(s) [8] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
Ohio
Country [9] 0 0
United States of America
State/province [9] 0 0
Pennsylvania

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00107718