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

Completed · Phase 2

Conditions studied: Renal Cell Carcinoma

In brief

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.

Key facts

Study ID

NCT00036036

Run by

Astellas Pharma Inc

People needed

14

Starts

2001-07-01

Expected to finish

2003-07-01

Last updated by the study team

2011-10-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• UCLA Medical Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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