A Clinical Trial Comparing Efficacy And Safety Of Sunitinib Versus Placebo For TheTreatment Of Patients At High Risk Of Recurrent Renal Cell Cancer

• Status: Completed
• Trial end date: 2017-09-07
• Target enrollment: 0
• Participant gender: All

Summary

To compare the disease free survival time and safety of sunitinib with placebo in adjuvant treatment patients at high risk of recurrent kidney cancer after surgery.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Sunitinib

Criteria

Inclusion Criteria:

• High risk renal cancer per modified UISS criteria

• Eastern Cooperative Oncology Group (ECOG) 0-2

• predominant clear cell histology

• No prior anti-cancer treatment

• Kidney tumor has been removed

• No evidence of macroscopic disease following surgery

Exclusion Criteria:

• Histologically undifferentiated carcinomas or collecting duct carcinoma, lymphoma, sarcoma or subjects with metastatic renal sites.

• Diagnosis of any second malignancy within the last 5 years, except basal cell carcinoma, squamous cell skin cancer, or in situ carcinoma of the cervix uteri that has been adequately treated with no evidence of recurrent disease for 12 months

• known HIV or Hepatitis

• any severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration