NCT00420888

ABR-217620/Naptumomab Estafenatox With Interferon-alpha (IFN-alpha) Compared to IFN-alpha Alone in Patients With Advanced Renal Cell Carcinoma

A Randomized, Open-label, Multi-center, Phase II/III Study on Treatment With ABR-217620/Naptumomab Estafenatox Combined With IFN-alpha vs. IFN-alpha Alone in Patients With Advanced Renal Cell Carcinoma.

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 526 (actual)
• Sponsor: Active Biotech AB · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The drug ABR-217620/naptumomab estafenatox is a fusion of two proteins, one that recognizes tumor cells and one that triggers an attack on the tumor cells by activating some white blood cells belonging to the body's normal immune system. This results in an accumulation of white blood cells in the cancer that can fight the cancer. This study will compare the safety and effectiveness (assessed by tumor status and survival) of ABR-217620/naptumomab estafenatox when given with standard therapy IFN-alpha to IFN-alpha alone in patients with advanced renal cell carcinoma (RCC).

Conditions

• Renal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	ABR-217620/naptumomab estafenatox	10 mcg/kg or 15 mcg/kg, 5 minute bolus intravenous injection on 4 consecutive days / 8 week cycle repeated 3 times
DRUG	IFN-alpha	3 MIU, 6 MIU, and 9 MIU, subcutaneous or intramuscular injection 3 times / week

Timeline

• Start date: 2007-01-01
• Primary completion: 2013-01-01
• Completion: 2013-01-01
• First posted: 2007-01-11
• Last updated: 2015-07-22

Locations

51 sites across 5 countries: Bulgaria, Romania, Russia, Ukraine, United Kingdom