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Clinical Trial Summary

Axitinib is a drug which is approved by the FDA for patients with advanced kidney cancer who have already received some treatment. It works by reducing blood flow to a tumor. Axitinib is normally give at 5mg twice per day and sometimes this dose is increased if patients tolerate it. The purpose of this study is to figure out a different way to decide which dose of axitinib each patient should receive based on the side effects they experience.


Clinical Trial Description

Primary objective To determine whether axitinib given on an individualized dose/schedule for metastatic renal cell carcinoma following immunotherapy with PD-1 and PD-L1 Inhibitors leads to improved progression-free survival (PFS). Secondary objectives: 1. To characterize the objective response rates in patients given axitinib on an individualized dose/schedule. 2. To evaluate the tolerability and safety of an alternative method of axitinib titration. 3. To characterize the anti-tumor effect, as measured by change in tumor burden per RECIST 1.1, of axitinib titration performed after initial RECIST PD on axitinib. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02579811
Study type Interventional
Source Case Comprehensive Cancer Center
Contact
Status Completed
Phase Phase 2
Start date December 30, 2015
Completion date June 20, 2023

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