drugset / Trial / NCT02579811
Axitinib Given on an Individualized Schedule for Metastatic Renal Cell Cancer
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |