Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Los Angeles, California 90095


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.


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.

Study is Available At:

Original ID:




Secondary ID:

Study Acronym:

Brief Title:

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

Official Title:

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

Overall Status:


Study Phase:

Phase 2



Minimum Age:

18 Years

Maximum Age:


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Astellas Pharma Inc

Oversight Authority:

United States: Food and Drug Administration

Reasons Why Stopped:

Study Type:


Study Design:

Allocation: Non-Randomized, Endpoint Classificati

Number of Arms:


Number of Groups:


Total Enrollment:


Enrollment Type:

Study Dates

Start Date:July 2001
Completion Date:July 2003
Completion Type:Actual
Verification Date:October 2011
Last Changed Date:October 14, 2011
First Received Date:May 7, 2002

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Astellas Pharma Inc
Agency Class:Industry
Agency Type:Collaborator
Agency Name:OSI Pharmaceuticals

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.

This study is not currently recruiting Study Participants. The form below is not enabled.