drugset / Trial / NCT02579811

Axitinib Given on an Individualized Schedule for Metastatic Renal Cell Cancer

NCT02579811 ↗

Phase 2 Completed 40 enrolled Case Comprehensive Cancer Center
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2015-12-30
Primary completion
2019-08-21
Completion
2023-06-20

Outcome

Missed primary endpoint

paper Individualised axitinib dosing in patients with metastatic renal cell inoma previously treated with checkpoint inhibitors did not meet the prespecified threshold for progression free survival PMID 31427205 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Axitinib Small molecule 5 mg Oral
Subject Axitinib Small molecule 6 mg Oral
Subject Axitinib Small molecule 7 mg Oral
Subject Axitinib Small molecule 8 mg Oral
Subject Axitinib Small molecule 9 mg Oral
Subject Axitinib Small molecule 10 mg Oral

Indications