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

Purpose:

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.

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.

Study is Available At:

Original ID:

OSI-461-003

NCT ID:

NCT00036036

Secondary ID:

Study Acronym:

Brief Title:

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

Official Title:

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

ClinicalTrials.gov Link:

http://clinicaltrials.gov/show/NCT00036036

Overall Status:

Completed

Study Phase:

Phase 2

Genders:

Both

Minimum Age:

18 Years

Maximum Age:

N/A

Study Source:

Astellas Pharma Inc

Oversight Authority:

United States: Food and Drug Administration

Reasons Why Stopped:

Study Type:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classificati

Number of Arms:

0

Number of Groups:

0

Total Enrollment:

14

Enrollment Type:

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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