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Sponsored by: |
Amgen |
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Information provided by: | Amgen |
ClinicalTrials.gov Identifier: | NCT00425035 |
Multicenter, 2-part, multiple-dose study designed to evaluate the safety and effectiveness of weekly administration of panitumumab in subjects with renal carcinoma. Part 1 was initiated in 2001 and will not be presented here. Part 2 was designed to examine a dose of 2.5 mg/kg/wk in 2 cohorts.
Condition | Intervention | Phase |
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Advanced Renal Cell Carcinoma |
Drug: Panitumumab (ABX-EGF) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Two-Part, Multiple Dose Clinical Trial Evaluating the Safety and Effectiveness of ABX-EGF in Patients With Renal Carcinoma |
Estimated Enrollment: | 115 |
Study Start Date: | February 2003 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Prior Therapy:
Adequate hematologic data, as follows:
Adequate renal function, as follows:
1. Creatinine < or = 2.2mg/dL
Adequate hepatic function, as follows:
Exclusion Criteria:
Responsible Party: | Amgen Inc. ( Global Development Leader ) |
Study ID Numbers: | 20020374, Abgenix protocol No. ABX-0303, Immunex protocol No. 054.0003 |
Study First Received: | January 18, 2007 |
Last Updated: | December 20, 2007 |
ClinicalTrials.gov Identifier: | NCT00425035 |
Health Authority: | United States: Food and Drug Administration |
Renal Cancer |
Urologic Diseases Kidney Neoplasms Carcinoma, Renal Cell Urogenital Neoplasms Renal cancer Kidney Diseases |
Kidney cancer Urologic Neoplasms Adenocarcinoma Urinary tract neoplasm Neoplasms, Glandular and Epithelial Carcinoma |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type |