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

This study has been completed.
Sponsor:
Collaborator:
OSI Pharmaceuticals
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00036036
First received: May 7, 2002
Last updated: October 14, 2011
Last verified: October 2011

May 7, 2002
October 14, 2011
July 2001
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Complete list of historical versions of study NCT00036036 on ClinicalTrials.gov 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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Renal Cell Carcinoma
Drug: CP-461
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
July 2003
Not Provided

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00036036
OSI-461-003
Not Provided
Astellas Pharma Inc
Astellas Pharma Inc
OSI Pharmaceuticals
Not Provided
Astellas Pharma Inc
October 2011

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