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

Tracking Information
First Received Date ^ICMJE	May 7, 2002
Last Updated Date	October 14, 2011
Start Date ^ICMJE	July 2001
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00036036 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Study of CP-461 in Patients With Advanced Renal Cell Cancer
Official Title ^ICMJE	Phase II Study of CP-461 in Patients With Advanced Renal Cell Cancer
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Renal Cell Carcinoma
Intervention ^ICMJE	Drug: CP-461
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	14
Completion Date	July 2003
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	Inclusion Criteria: Measurable metastatic or locally advanced disease. Histologically confirmed renal cell cancer. 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. Expected remaining life span > or = three months. ECOG performance status 0-2. > or = 18 years of legal age. Male patients, or non-pregnant and non-lactating female patients who are either using adequate birth control, surgically sterile or post-menopausal. Negative serum pregnancy test, if fertile female. Willingness and ability to sign an informed consent document. Exclusion Criteria: Uncontrolled or symptomatic brain metastases. Use of an investigational medication or device within one month of initiating study therapy. 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. Any condition or any medication which may interfere with the conduct of the study. Current active malignancy other than renal cell cancer.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00036036
Other Study ID Numbers ^ICMJE	OSI-461-003
Has Data Monitoring Committee	Not Provided
Responsible Party	Astellas Pharma Inc
Study Sponsor ^ICMJE	Astellas Pharma Inc
Collaborators ^ICMJE	OSI Pharmaceuticals
Investigators ^ICMJE	Not Provided
Information Provided By	Astellas Pharma Inc
Verification Date	October 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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