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

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ClinicalTrials.gov Identifier: NCT00036036
Recruitment Status : Completed
First Posted : May 8, 2002
Last Update Posted : October 17, 2011
Sponsor:
Collaborator:
OSI Pharmaceuticals
Information provided by (Responsible Party):
Astellas Pharma Inc

Brief 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.

Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma Drug: CP-461 Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 14 participants
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
Study Start Date : July 2001
Actual Study Completion Date : July 2003

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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00036036


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

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00036036     History of Changes
Other Study ID Numbers: OSI-461-003
First Posted: May 8, 2002    Key Record Dates
Last Update Posted: October 17, 2011
Last Verified: October 2011

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

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases