Status:
COMPLETED
Efficacy Study of IL-21 to Treat Metastatic Melanoma
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Cancer
Malignant Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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,...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00336986
Start Date
September 1 2004
End Date
October 1 2007
Last Update
August 14 2023
Active Locations (7)
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1
Novo Nordisk Investigational Site
Box Hill, Australia, 3128
2
Novo Nordisk Investigational Site
East Melbourne, Australia, 3002
3
Novo Nordisk Investigational Site
Heidelberg, Australia, 3084
4
Novo Nordisk Investigational Site
Malvern, Australia, 3144