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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
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00036036

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

No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00036036     History of Changes
Other Study ID Numbers: OSI-461-003
Study First Received: May 7, 2002
Last Updated: October 14, 2011
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on May 16, 2013