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

• Status: Completed
• Trial end date: 2003-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Collaborator: OSI Pharmaceuticals

Criteria

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.