NCT00389285

Study of Recombinant Interleukin 21 in Combination With Sorafenib for Metastatic Renal Cell Carcinoma

A Phase 1/2, Open-Label, Dose Escalation Study to Assess the Safety and Pharmacokinetics of Recombinant Interleukin 21 (rIL-21) Administered Concomitantly With Sorafenib (Nexavar) in Subjects With Metastatic Renal Cell Carcinoma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: ZymoGenetics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate whether recombinant IL-21 used in combination with sorafenib is safe for patients with metastatic renal cell carcinoma (RCC).

Detailed description

This is a Phase 1/2 open-label dose-escalation study of rIL-21 given in combination with sorafenib to patients with metastatic RCC. The Phase 1 part of this study will estimate the maximum tolerated dose of rIL-21 given for 1 treatment course (consisting of two 5-day cycles of rIL-21) in combination with a standard dose of sorafenib administered during a 6-week treatment course. Increasing doses of rIL-21 will be studied sequentially in different groups of patients. The Phase 2 part of the study will further evaluate the safety and preliminary antitumor activity of rIL-21 at the dose recommended from Phase 1 in combination with sorafenib. Patients will be evaluated for safety over the course of the study. Disease evaluation (tumor restaging) will be performed during the last week of each 6-week treatment course. Patients with stable disease or better at this evaluation may go on to receive additional treatment courses. Patients may be in the study for 2 to 7 months.

Conditions

• Carcinoma, Renal Cell

Interventions

Type	Name	Description
DRUG	rIL-21 only	Part 1: rIL-21, IV, Day 1-5 and 15-19 of each 6-week treatment course
DRUG	rIL-21 + sorafenib	Part 2: rIL-21 IV, Day 1-5 and 15-19 of each 6-week treatment course + sorafenib (up to 400 mg taken orally twice daily)

Timeline

• Start date: 2006-10-01
• Primary completion: 2009-05-01
• Completion: 2009-05-01
• First posted: 2006-10-18
• Last updated: 2009-05-27

Locations

3 sites across 1 country: United States