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Sponsored by: |
Active Biotech Research |
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Information provided by: | Active Biotech Research |
ClinicalTrials.gov Identifier: | NCT00420888 |
The drug ABR-217620 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 when given with standard therapy IFN-alpha to IFN-alpha alone in patients with advanced renal cell carcinoma (RCC).
Condition | Intervention | Phase |
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Renal Cell Carcinoma |
Drug: ABR-217620 Drug: IFN-alpha |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Open-Label, Multi-Center, Phase II/III Study on Treatment With ABR-217620 Combined With IFN-Alpha vs. IFN-Alpha Alone in Patients With Advanced Renal Cell Carcinoma. |
Enrollment: | 526 |
Study Start Date: | January 2007 |
Estimated Study Completion Date: | August 2011 |
Estimated Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Safety group: Experimental
6-12 patients
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Drug: ABR-217620
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
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1: Experimental |
Drug: ABR-217620
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
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2
Standard treatment with IFN-alpha without add-on of ABR-217620
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Drug: IFN-alpha
3 MIU, 6 MIU, and 9 MIU, subcutaneous or intramuscular injection 3 times / week
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Baseline blood counts:
Baseline blood chemistry levels:
Exclusion Criteria:
Study Director: | Thore Nederman, PhD | Active Biotech Research |
Responsible Party: | Active Biotech Research ( Lars M Nilsson, DVM / VP Regulatory & Quality Affairs ) |
Study ID Numbers: | 06762004 |
Study First Received: | January 9, 2007 |
Last Updated: | June 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00420888 History of Changes |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency; Russia: Ministry of Health and Social Development of the Russian Federation; Bulgaria: Ministry of Health; Romania: National Medicines Agency; Ukraine: Ministry of Health |
Interferon-alpha Anti-Infective Agents Urinary Tract Neoplasm Kidney Cancer Immunologic Factors Interferons Urogenital Neoplasms Urologic Neoplasms Antiviral Agents |
Carcinoma Renal Cancer Urologic Diseases Kidney Neoplasms Carcinoma, Renal Cell Kidney Diseases Adenocarcinoma Interferon Alfa-2a Neoplasms, Glandular and Epithelial |
Interferon-alpha Anti-Infective Agents Neoplasms by Histologic Type Immunologic Factors Physiological Effects of Drugs Urogenital Neoplasms Urologic Neoplasms Antiviral Agents Pharmacologic Actions Carcinoma |
Neoplasms Neoplasms by Site Urologic Diseases Kidney Neoplasms Therapeutic Uses Carcinoma, Renal Cell Kidney Diseases Adenocarcinoma Neoplasms, Glandular and Epithelial |