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

Phase 2
18 Years
Not Enrolling
Renal Cell Carcinoma

Thank you

Trial Information

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

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

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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


United States: Food and Drug Administration

Study ID:




Start Date:

July 2001

Completion Date:

July 2003

Related Keywords:

  • Renal Cell Carcinoma
  • renal
  • renal cell cancer
  • renal cell carcinoma
  • kidney cancer
  • Carcinoma
  • Carcinoma, Renal Cell



UCLA Medical Center Los Angeles, California  90095-7059