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

This study has been completed.
OSI Pharmaceuticals
Information provided by (Responsible Party):
Astellas Pharma Inc Identifier:
First received: May 7, 2002
Last updated: October 14, 2011
Last verified: October 2011
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.

Condition Intervention Phase
Renal Cell Carcinoma Drug: CP-461 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of CP-461 in Patients With Advanced Renal Cell Cancer

Resource links provided by NLM:

Further study details as provided by Astellas Pharma Inc:

Estimated Enrollment: 14
Study Start Date: July 2001
Study Completion Date: July 2003

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00036036

United States, California
UCLA Medical Center
Los Angeles, California, United States, 90095
Sponsors and Collaborators
Astellas Pharma Inc
OSI Pharmaceuticals
  More Information

Responsible Party: Astellas Pharma Inc Identifier: NCT00036036     History of Changes
Other Study ID Numbers: OSI-461-003
Study First Received: May 7, 2002
Last Updated: October 14, 2011

Keywords provided by Astellas Pharma Inc:
renal cell cancer
renal cell carcinoma
kidney cancer

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases processed this record on September 21, 2017