Adjuvant Axitinib Therapy of Renal Cell Cancer in High Risk Patients

Summary

The purpose of this trial is to determine if adjuvant therapy with axitinib will prevent or delay the recurrence of renal cell cancer after surgery to remove the primary tumor in high risk patients.

Timeline

Start

2012-04

Primary completion

2017-10-10

Completion

2018-05

Outcome

Missed primary endpoint

Stopped: “Primary endpoint did not reach statistical significance”

registry analysis (superiority test); Axitinib vs Placebo; p = 0.3211; Hazard Ratio (HR) 0.870 (95% CI 0.660 to 1.147); Log Rank NCT01599754 ↗

paper ATLAS did not meet its primary end point; however, improvement in DFS per investigator was seen in the highest-risk subpopulation. PMID 30346481 ↗

Publications

• Gross-Goupil M, Kwon TG, Eto M, Ye D, Miyake H, Seo SI, Byun SS, Lee JL, Master V, Jin J, DeBenedetto R, Linke R, Casey M, Rosbrook B, Lechuga M, Valota O, Grande E, Quinn DI. Axitinib versus placebo as an adjuvant treatment of renal cell carcinoma: results from the phase III, randomized ATLAS trial. Ann Oncol. 2018 Dec 1;29(12):2371-2378. doi: 10.1093/annonc/mdy454.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Axitinib	Small molecule	5 mg	—

Indications