Study of CP-461 in Patients With Advanced Renal Cell Cancer
This study has been completed.
Information provided by (Responsible Party):
Astellas Pharma Inc
First received: May 7, 2002
Last updated: October 14, 2011
Last verified: October 2011
The purpose of this study is to determine the efficacy of CP-461 given twice-daily orally in locally advanced or metastatic renal cell cancer and to evaluate the safety profile of CP-461 in this patient population.
Renal Cell Carcinoma
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Phase II Study of CP-461 in Patients With Advanced Renal Cell Cancer
| Estimated Enrollment:
| Study Start Date:
| Study Completion Date:
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Measurable metastatic or locally advanced disease.
- Histologically confirmed renal cell cancer.
- No radiotherapy within 4 weeks prior to entering the study. No more than 1 prior systemic therapy for advanced disease. Prior adjuvant systemic therapy is allowed. Patients must have fully recovered from the acute effects of prior therapy.
- Expected remaining life span > or = three months.
- ECOG performance status 0-2.
- > or = 18 years of legal age.
- Male patients, or non-pregnant and non-lactating female patients who are either using adequate birth control, surgically sterile or post-menopausal.
- Negative serum pregnancy test, if fertile female.
- Willingness and ability to sign an informed consent document.
- Uncontrolled or symptomatic brain metastases.
- Use of an investigational medication or device within one month of initiating study therapy.
- Absolute granulocyte count < or = 1500/mm3; Platelet count < or = 100,000/mm3; total serum bilirubin above the upper limit of normal; serum creatinine > or = 2.2 mg/dL; AST/ALT > 2.5 ULN.
- Any condition or any medication which may interfere with the conduct of the study.
- Current active malignancy other than renal cell cancer.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00036036
|UCLA Medical Center
|Los Angeles, California, United States, 90095 |
Astellas Pharma Inc
No publications provided
||Astellas Pharma Inc
History of Changes
|Other Study ID Numbers:
|Study First Received:
||May 7, 2002
||October 14, 2011
||United States: Food and Drug Administration
Keywords provided by Astellas Pharma Inc:
renal cell cancer
renal cell carcinoma
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 16, 2013
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site