Combination of Recombinant Human IL-21 (rIL-21) and Sunitinib in Stage IV Renal Cell Carcinoma Patients

• Status: Completed
• Trial end date: 2008-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Sunitinib

Criteria

Inclusion Criteria:

• Histologically verified and surgically incurable stage IV Renal Cell Carcinoma

• ECOG performance status of 0 or 1 (i.e. good performance status)

• Life expectancy of at least 3 months

Exclusion Criteria:

• Prior systemic therapy for metastatic disease

• Radiotherapy within the last 4 weeks prior to start of treatment

• Receipt of any investigational drug within 3 months of starting treatment

• History of any other active malignancy within five years prior to enrolment