Treatment Use Study With Sunitinib (SU011248) For Patients With Cytokine-Refractory Metastatic Renal Cell Carcinoma
Sponsor: Pfizer
ClinicalTrials ID:NCT00130897
This Expanded Access study provides SU011248 (Sutent) to patients with metastatic RCC who cannot join other trials. Eligibility requires RCC not treatable with curative intent and excludes those in other therapeutic trials. Sutent is administered daily in doses of 25, 37.5, or 50 mg. Basic results are not reported as it is not a controlled clinical investigation.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The primary objective of this protocol is to provide access to SU011248 treatment for patients with metastatic RCC who are ineligible for participation in ongoing SU011248 clinical studies and have the potential to derive clinical benefit from treatment with SU011248 based on the judgment of the investigator.
Description
Given that an Expanded Access study does not meet the definition of a controlled clinical investigation, and as such, is not considered an applicable drug clinical trial per NIH, Basic Results for such studies are not required to be reported. Protocol A6181037 has been identified as an Expanded Access trial, and has been registered to ClinicalTrials.gov, however Basic Results will not be posted.
Eligibility Criteria
Inclusion Criteria
- renal cell carcinoma that is not amendable to standard therapy with curative intent
Exclusion Criteria
- current treatment in another therapeutic clinical trial
Get This Program In Your Inbox
You can sign up and apply your patients for this program.