drugset / Trial / NCT00617253
Combination of Recombinant Human IL-21 (rIL-21) and Sunitinib in Stage IV Renal Cell Carcinoma Patients
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This phase 1/2a trial is conducted in Europe. The first part of the trial is a dose escalation safety trial determining the maximum tolerated dose of rIL-21 when administered in combination with sunitinib. The second part, scheduled to start in September 2008, is a randomised 2-arm trial comparing the anti-tumour effect of rIL-21 plus sunitinib with sunitinib alone.
Timeline
- Start
- 2007-07-12
- Primary completion
- 2008-06-30
- Completion
- 2008-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sunitinib | Small molecule | 12.5 mg | — |
| Subject | recombinant interleukin-21 | Protein / enzyme biologic | 3 ug/kg | Subcutaneous |
| Subject | recombinant interleukin-21 | Protein / enzyme biologic | 10 ug/kg | Subcutaneous |
| Subject | recombinant interleukin-21 | Protein / enzyme biologic | 30 ug/kg | Subcutaneous |
| Subject | recombinant interleukin-21 | Protein / enzyme biologic | 100 ug/kg | Subcutaneous |