AA SU011248 TREATMENT PROTOCOL FOR PATIENTS WITH CYTOKINE- REFRACTORY METASTATIC RENAL CELL CARCINOMA WHO ARE INELIGIBLE FOR PARTICIPATION IN OTHER SU011248 PROTOCOLS AND MAY DERIVE BENEFIT FROM TREATMENT WITH SU011248

Pfizer Inc0 sites1,000 target enrollmentSeptember 21, 2005

Overview

No summary available.

Registry

who.int

Start Date

September 21, 2005

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Patients must meet all of the following inclusion criteria to be eligible for enrollment into the trial:
•1\. Histopathologically confirmed renal cell carcinoma with metastase
•2\. Must be ineligible for participation in ongoing SU011248 clinical studies (if any Phase 1, 2 or 3 SU011248 protocols for patients having RCC are open to enrollment at the institution).
•3\. Judged by the treating physician to have the potential to derive clinical benefit from SU011248 treatment.
•4\. Male or female, 18 years of age or older.
•5\. If previously treated for metastatic RCC, the resolution of all acute toxic effects or prior system therapy, radiotherapy or surgical procedure to NCI CTCAE Vrsion 3\.0 grade less/equal to 1
•6\. Adequate organ function as defined by the following criteria:
•Total serum bilirubin less/equal to 2 x ULN (patients with Gilbert’s disease exempt)
•Serum transaminases \<5 x ULN
•Serum creatinine less/equal 2 x ULN

•1\. Current treatment in another therapeutic clinical trial
•2\. Congestive heart failure, myocardial infarction or coronary artery bypass graft in the previous six months, ongoing severe or unstable angina or any unstable arrhythmia requiring medication
•3\. Previous treatment on a SU011248 trial except for those patients who received IFN\-aipha therapy in Protocol A6181034 and either had radiographic documentation of disease progression or were IFN\-aipha inolerant.
•4\. Pregnancy or breastfeeding. Patients must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of therapy. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate. Male patients must be surgically sterile or agree to use effective contraception.
•5\. Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study