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

Renal Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00036036
• Other study ID #: OSI-461-003
• Status: Completed
• Phase: Phase 2
• First received: May 7, 2002
• Last updated: October 14, 2011
• Start date: July 2001
• Est. completion date: July 2003

Study information

• Verified date: October 2011
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: July 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Renal Cell Carcinoma

Intervention

Drug:
• CP-461

Locations

Country	Name	City	State
United States	UCLA Medical Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Astellas Pharma Inc	OSI Pharmaceuticals

Country where clinical trial is conducted

United States,