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

Astellas

Status and phase: Completed; Phase 2

Conditions: Renal Cell Carcinoma

Treatments: Drug: CP-461

Study type: Interventional

Funder types: Industry

Identifiers

NCT00036036

OSI-461-003

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)