drugset / Trial / NCT01693822

A Phase II Study of Axitinib in Patients With Metastatic Renal Cell Cancer Unsuitable for Nephrectomy

NCT01693822

NaSingle-groupOpen-labelTreatment

Summary

A-PREDICT is a study of axitinib in patients with metastatic renal cell carcinoma unsuitable for nephrectomy (as judged by the treating clinician) to evaluate efficacy, safety, toxicity and changes in biomarkers during therapy. Axitinib will given twice daily by mouth according to tolerability of treatment, for as long as patients are deriving clinical benefit. Blood and tumour tissue samples will be taken prior to and during therapy to evaluate biomarkers of treatment response. The primary clinical objective of this study is to define the activity of axitinib given to patients with metastatic renal cell carcinoma unsuitable for nephrectomy.

Timeline

Start
2012-10
Primary completion
2017-03
Completion
2022-02-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Axitinib Small molecule 10 mg Oral