轉移性腎臟腫瘤

一項SU011248治療性計畫,用於cytodine治療失效,無法參加SU011248其他計畫及可能使用SU011248獲得益處的轉移性腎細胞病患

膠囊劑

SUNITINIB MALATE

130

12.5mg/ 25mg/ 50mg

• Safety profile of SU011248
• Overall survival (OS)
• Time-to-progression (TTP)
• Progression-free survival (PFS)
• Objective response rate (ORR)

Patients must meet all of the following inclusion criteria to be eligible for enrollment into the trial:
1. Histopathologically confirmed renal cell carcinoma with metastases.
2. Renal cell carcinoma that is not amenable to standard therapy with curative intent.
3. Have cytokine-refractory disease
4. 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).
5. Judged by the treating physician to have the potential to derive clinical benefit from SU011248 treatment.
6. Male or female, 18 years of age or older.
7. Resolution of all acute toxic effects of prior systemic therapy, radiotherapy or surgical procedure to NCI CTCAE Version 3.0 grade less/equal to 1.
8. 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
• Absolute neutrophil count (ANC) major/equal to 1000/mL without growth factor support
• Platelets major/equal to 75,000/mL
• Hemoglobin major/equal to 8.0 g/dL
9. 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.
10. Willingness and ability to comply with scheduled visits, treatment plans and laboratory tests and other study procedures.

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
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