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| Sponsored by: |
Eisai Medical Research Inc. |
| Information provided by: | Eisai Medical Research Inc. |
| ClinicalTrials.gov Identifier: | NCT00059735 |
Purpose
The purpose of this study is to determine if E7070 is a safe and effective treatment for cancer of the kidneys.
| Condition | Intervention | Phase |
|
Kidney Neoplasms Carcinoma, Renal Cell Adenocarcinoma, Renal Cell |
Drug: E7070 |
Phase II |
| MedlinePlus related topics: | Cancer Kidney Cancer |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | A Phase II Study of E7070 in Patients With Progressive Inoperable and/or Metastatic Renal Cell Carcinoma (RCC) |
| Enrollment: | 30 |
| Study Start Date: | May 2002 |
| Study Completion Date: | December 2003 |
Renal Cell Carcinoma (RCC) accounts for approximately 2% of all cancers and its incidence is increasing with worldwide deaths of over 100,000 patients per year. About 50% of RCC patients have inoperable or metastatic disease that surgery cannot be performed on. RCC is also considered to be resistant to both radiotherapy and cytotoxic chemotherapy. The purpose of this study is to evaluate the safety and effectiveness of E7070 by assessing progression free survival, tumor response rate, duration of response/stable disease, and survival time. E7070 will be administered as a single iv infusion over 60 minutes on Day 1 of each cycle. Patients will continue treatment with E7070 until they no longer have clinical benefit and have disease progression, or toxicity leads to patient withdrawal.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |||||
| Sacramento, California, United States, 95817 | |||||
| United States, New York | |||||
| Bronx, New York, United States, 10466 | |||||
| New York, New York, United States, 10021 | |||||
| New York, New York, United States, 10032 | |||||
| France | |||||
| Villejuif Cedex, France, 94805 | |||||
| Eisai Medical Research Inc. |
| Study Director: | Murray Yule, MRCP, PhD | Eisai Limited |
More Information
Related Info 
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| Study ID Numbers: | E7070-A001-206 |
| First Received: | May 5, 2003 |
| Last Updated: | February 29, 2008 |
| ClinicalTrials.gov Identifier: | NCT00059735 |
| Health Authority: | United States: Food and Drug Administration |
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