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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00336986




Registration number
NCT00336986
Ethics application status
Date submitted
14/06/2006
Date registered
15/06/2006
Date last updated
14/08/2023

Titles & IDs
Public title
Efficacy Study of IL-21 to Treat Metastatic Melanoma
Scientific title
An Open-label, Dose Escalation Safety and Tolerability Study of Recombinant Human Interleukin-21 (Phase 1) Followed by an Open-label Treatment Study (Phase 2a) in Patients With Stage IV Malignant Melanoma
Secondary ID [1] 0 0
NN028-1614
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 0 0
Malignant 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
Tumor size assessed according to international criteria
Timepoint [1] 0 0
After 8 weeks
Secondary outcome [1] 0 0
Serum levels of antibodies against recombinant human IL-21.
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Markers of immunomodulation in blood.
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Safety evaluation.
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Time to progression.
Timepoint [4] 0 0

Eligibility
Key inclusion criteria
* Histologically confirmed surgically incurable metastatic melanoma
* Patients must have measurable disease
* ECOG performance status of 0 or 1
* Expected life expectancy at least 4 months
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* History of and signs/symptoms of uncontrolled brain metastases or edema.
* Previous treatment with chemotherapy or any biological anti-cancer drug (prior adjuvant therapy with interferon-alpha is permitted as long as treatment was completed at least six months prior to study entry.)
* Radiotherapy: Radiation therapy within 4 weeks prior to entering the study.
* Receipt of any investigational drug for treatment of metastatic melanoma prior to this trial.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Single group
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
1/09/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2007
Sample size
Target
Accrual to date
Final
54
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Novo Nordisk Investigational Site - Box Hill
Recruitment hospital [2] 0 0
Novo Nordisk Investigational Site - East Melbourne
Recruitment hospital [3] 0 0
Novo Nordisk Investigational Site - Heidelberg
Recruitment hospital [4] 0 0
Novo Nordisk Investigational Site - Malvern
Recruitment hospital [5] 0 0
Novo Nordisk Investigational Site - Nedlands
Recruitment hospital [6] 0 0
Novo Nordisk Investigational Site - Parkville
Recruitment hospital [7] 0 0
Novo Nordisk Investigational Site - Westmead
Recruitment postcode(s) [1] 0 0
3128 - Box Hill
Recruitment postcode(s) [2] 0 0
3002 - East Melbourne
Recruitment postcode(s) [3] 0 0
3084 - Heidelberg
Recruitment postcode(s) [4] 0 0
3144 - Malvern
Recruitment postcode(s) [5] 0 0
6009 - Nedlands
Recruitment postcode(s) [6] 0 0
3050 - Parkville
Recruitment postcode(s) [7] 0 0
2145 - Westmead

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novo Nordisk A/S
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This trial is conducted in Oceania. A phase 2a study to assess the effect on tumor size. At least 14 to a maximum of 40 patients, who have not previously received treatment for their stage IV disease, will be treated for 6 weeks. IL-21 will be administered intravenously.
Trial website
https://clinicaltrials.gov/study/NCT00336986
Trial related presentations / publications
Coquet JM, Skak K, Davis ID, Smyth MJ, Godfrey DI. IL-21 Modulates Activation of NKT Cells in Patients with Stage IV Malignant Melanoma. Clin Transl Immunology. 2013 Oct 18;2(10):e6. doi: 10.1038/cti.2013.7. eCollection 2013 Oct.
Public notes

Contacts
Principal investigator
Name 0 0
Global Clinical Registry (GCR; 1452)
Address 0 0
Novo Nordisk A/S
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00336986