Study of CP-461 in Patients With Advanced Renal Cell Cancer

Phase II Study of CP-461 in Patients With Advanced Renal Cell Cancer

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.

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.