None listed
Conditions
Interventions
This group will be treated with SU011248 50 mg PO QD every day for 4 weeks, after this a 2-week rest order will follow, in order to complete a 6-week treatment cycle. Patients will continue with subsequent treatment cycles as long as there is evidence of disease control in the opinion of the investigator.
The dose of the treatment can be reduced up to a maximum of 2 opportunities up to 25 mg or 12.5 mg PO QD according to patient tolerance.
Sponsors
PFIZER S.A.,
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Physical examination and evaluation of the disease according to local criteria for the management of the CCR. Measure:Global survival Progression free survival. Time for progression Objective response rate. Timepoints:Before starting treatment, day 1 of each cycle at the end of treatment and during follow-up. In addition, follow-up information on survival for all patients will be obtained by clinical visit or telephone contact every 2 months for up to 2 years from the date of the first dose of SU011248. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical examination of adverse events. Biochemistry and hematology panels. 12-lead ECG. Measure:Toxicity of the treatment. Timepoints:Evaluation of adverse events, biochemistry and hematology panels: Before treatment, days 1 and 28 of each treatment cycle, at the end of therapy and during follow-up if necessary. 12-lead ECG: Days 1 and 28 of cycle 1, at the end of treatment and during follow-up. | — |
Countries
Argentina, Australia, Austria, Belgium, Bosnial and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Korea South, Lebano, Malasya, Mexico, Netherlands, Norway, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kindgdom, United States, Venezuela
Outcome results
None listed