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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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 July 01, 2015
Carcinoma, Renal Cell
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial