A SU011248 EXPANDED ACCESS PROTOCOL FOR SYSTEMIC THERAPY OF PATIENTS WITH METASTATIC RENAL CELL CARCINOMA WHO ARE INELIGIBLE FOR PARTICIPATION IN OTHER SU011248 PROTOCOLS BUT MAY DERIVE BENEFIT FROM TREATMENT WITH SU011248

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 5000

Inclusion Criteria

1. Histopathologically confirmed renal cell carcinoma with metastases. 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, resolution of all acute toxic effects of prior systemic therapy, radiotherapy or surgical procedure to NCI CTCAE Version 3.0 Grade ≤1 (Appendix 3). 6. Adequate organ function as defined by the following criteria: ? Total serum bilirubin ≤2 x ULN (patients with Gilbert's disease exempt); ? Serum transaminases <5 x ULN; ? Serum creatinine ≤2 x ULN; ? Absolute neutrophil count (ANC) ≥1000/mm3 without growth factor support; ? Platelets ≥75,000/mm3; ? Hemoglobin ≥8.0 g/Dl. 7. Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrollment. 8. Willingness and ability to comply with scheduled visits, treatment plans and laboratory tests and other study procedures. 9. As required by local regulations, eg, United Kingdom, ECOG performance status of 0, 1 or 2.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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-α therapy in Protocol A6181034 and either had radiographic documentation of disease progression or were IFN-α intolerant. 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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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