Renal Cell Carcinoma
Conditions
Keywords
renal, renal cell cancer, renal cell carcinoma, kidney cancer
Brief summary
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.
Interventions
DRUGCP-461
Sponsors
OSI Pharmaceuticals
Astellas Pharma Inc
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Measurable metastatic or locally advanced disease. 2. Histologically confirmed renal cell cancer. 3. 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. 4. Expected remaining life span \> or = three months. 5. ECOG performance status 0-2. 6. \> or = 18 years of legal age. 7. Male patients, or non-pregnant and non-lactating female patients who are either using adequate birth control, surgically sterile or post-menopausal. 8. Negative serum pregnancy test, if fertile female. 9. Willingness and ability to sign an informed consent document.
Exclusion criteria
1. Uncontrolled or symptomatic brain metastases. 2. Use of an investigational medication or device within one month of initiating study therapy. 3. 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. 4. Any condition or any medication which may interfere with the conduct of the study. 5. Current active malignancy other than renal cell cancer.
Countries
United States
Outcome results
None listed