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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00036036
Recruitment Status : Completed
First Posted : May 8, 2002
Last Update Posted : October 17, 2011
OSI Pharmaceuticals
Information provided by (Responsible Party):
Astellas Pharma Inc

May 7, 2002
May 8, 2002
October 17, 2011
July 2001
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Complete list of historical versions of study NCT00036036 on Archive Site
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Study of CP-461 in Patients With Advanced Renal Cell Cancer
Phase II Study of CP-461 in Patients With Advanced Renal Cell Cancer
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.
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Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Renal Cell Carcinoma
Drug: CP-461
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
July 2003
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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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Astellas Pharma Inc
Astellas Pharma Inc
OSI Pharmaceuticals
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Astellas Pharma Inc
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP