Axitinib Given on an Individualized Schedule for Metastatic Renal Cell Cancer

Metastatic Renal Cell Cancer Clinical Trial

Official title: A Phase II Study of the Efficacy and Safety of Axitinib Given on an Individualized Schedule for Metastatic Renal Cell Cancer After Treatment With Pd-1 or Pd-L1 Inhibitors

Status Completed

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. ;

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Metastatic Renal Cell Cancer

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