Axitinib in Metastatic Renal Cell Carcinoma Patients With Favorable Prognostic Factors

• Status: Completed
• Trial end date: 2018-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Aim of the FavorAx study is to evaluate preliminary efficacy and safety of Axitinib in metastatic renal cell carcinoma patients with favorable IMDC prognostic factors who had progressed on sunitinib or pazopanib in the first-line setting.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kidney Cancer Research Bureau
• Treatments: Axitinib

Criteria

Principle Inclusion Criteria:

• Histologic confirmation of Renal cell carcinoma with a clear cell component

• Patients must have measurable disease

• Previous treatment with sunitinib or pazopanib

• Favorable prognosis according to IMDC criteria

• Must have available tumor tissue for submission

• Subjects must also meet various laboratory parameters for inclusion

• Patients must give written informed consent prior to initiation of therapy

Exclusion Criteria:

• Any underlying medical condition, which in the opinion of the Investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events

• Patients who have history of uncompensated diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the subject at high risk from treatment complications.