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| Sponsor: | Amgen |
|---|---|
| Information provided by: | Amgen |
| ClinicalTrials.gov Identifier: | NCT00425035 |
Purpose
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 |
|---|---|---|
|
Advanced Renal Cell Carcinoma |
Drug: Panitumumab (ABX-EGF) |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Eligibility| 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:
Contacts and Locations
More Information
| Responsible Party: | Global Development Leader, Amgen Inc. |
| ClinicalTrials.gov Identifier: | NCT00425035 History of Changes |
| Obsolete Identifiers: | NCT00036530 |
| Other Study ID Numbers: | 20020374, Abgenix protocol No. ABX-0303, Immunex protocol No. 054.0003 |
| Study First Received: | January 18, 2007 |
| Last Updated: | April 16, 2009 |
| Health Authority: | United States: Food and Drug Administration |
|
Renal Cancer |
|
Carcinoma Kidney Neoplasms Carcinoma, Renal Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases Urologic Diseases Adenocarcinoma |