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

NCT00389285 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2009-05-27

No results posted yet for this study

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).

Conditions

  • Carcinoma, Renal Cell

Interventions

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)

Sponsors & Collaborators

  • ZymoGenetics

    lead INDUSTRY

Principal Investigators

  • Naomi Hunder, MD · ZymoGenetics

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2009-05-31
Completion
2009-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00389285 on ClinicalTrials.gov