Treatment Use Study With Sunitinib (SU011248) For Patients With Cytokine-Refractory Metastatic Renal Cell Carcinoma

Not Applicable

• Conditions: -C64 Malignant neoplasm of kidney, except renal pelvis; Malignant neoplasm of kidney, except renal pelvis; C64

• Registration Number: PER-019-06
• Lead Sponsor: PFIZER S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-06-13
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1067/5000
1. Renal cell carcinoma with metastasis, histopathologically confirmed.
2. Patients must be ineligible to participate in ongoing clinical trials with SU011248.
3. The attending physician considers that the patient can obtain a clinical benefit from treatment with SU011248.
4. Men or women, 18 years of age or older.
5. If the patient has been previously treated for metastatic CRC, evidence of resolution of all the acute toxic effects of a previous systemic therapy, radiotherapy or surgical procedure is necessary.
6. Adequate organic function.
7. Signed and dated informed consent document indicating that the patient (or their legally acceptable representative) has been informed about all relevant aspects of the study prior to admission.
8. The patient wants and can comply with scheduled visits, treatment plans and laboratory tests, and with other study procedures.
9. As required by local regulations, a functional status of ECOG of 0.1 or 2.

Exclusion Criteria

1. Current treatment in another therapeutic clinical study.
2. Congestive heart failure, myocardial infarction or coronary bypass surgery in the previous six months, severe or unstable current angina, or any unstable arrhythmia that requires medication.
3. Previous treatment in a study with SU011248, except those patients who received therapy with IFN-a in Protocol A6181034 and who had either radiographic documentation of disease progression or were intolerant to IFN-a.
4. Pregnancy or lactation. Patients must be surgically sterile or postmenopausal, or they must agree to use an effective contraceptive method during the therapy period. The definition of effective contraception will be based on the criteria of the principal investigator or a designated collaborator. Male patients must be surgically sterile or agree to use an effective method of contraception.
5. Other severe acute or chronic medical or psychiatric condition, or
laboratory abnormality that would imply an excessive risk or that makes the patient not suitable to enter this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified