Histopathologically confirmed renal cell carcinoma with metastases MedDRA version: 8.0 Level: LLT Classification code 10038415
Conditions
Interventions
Trade Name: SUTENT
Product Name: Sutent
Product Code: su011248
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: sunitinib malate
Sponsors
PFIZER Inc 235 East 42nd Street, New York, NY, 10017
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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.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 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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 recieved IFN-alpha therapy in Protocol A6181034 and either had radiographic documentation of disease progression or were IFN-alpha 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this protocol is to provide access to SU011248 treatment for patients with metastatic RCC given all of the following conditions are met: a) patients are 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) except for those patients who recieved IFN-alpha therapy in Protocol A6181034 and either had radiographic documentation of disease progression or were IFN-alpha intolerant, and b) patients have the potential to derive clinical benefit from treatment with SU011248 based on the judgment of the investigator. ; Secondary Objective: Other objectives include the assessment of: • Safety and tolerability profile of SU011248 • The antitumor efficacy of single-agent SU011248 given orally at a dose of 50 mg in patients with metastatic RCC ; Primary end point(s): The primary objective is to provide access to SU011248 treatment for patients with metastatic RCC according to conditions described in the protocol without formal hypothesis testing. In addition, the following clinical endpoints will be evaluated. •Safety profile of SU011248 •Overall survival (OS) •Time-to-progression (TTP) •Progression-free survival (PFS) •Objective response rate (ORR) | — |
Countries
Austria, Finland, Germany, Hungary, Ireland, Italy, Portugal, Slovakia, Slovenia, Spain, Sweden, United Kingdom
Outcome results
None listed