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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
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.
Details
| Lead sponsor | Novo Nordisk A/S |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 54 |
| Start date | 2004-09 |
| Completion | 2007-10 |
Conditions
- Cancer
- Malignant Melanoma
Interventions
- recombinant interleukin-21
Primary outcomes
- Tumor size assessed according to international criteria — After 8 weeks
Countries
Australia