drugset / Trial / NCT03334409

Pazopanib Hydrochloride With or Without Ascorbic Acid in Treating Patients With Kidney Cancer That Is Metastatic or Cannot Be Removed by Surgery

NCT03334409 ↗

RandomizedParallel-groupOpen-labelTreatment

Summary

This randomized phase II trial studies how well pazopanib hydrochloride with or without ascorbic acid work in treating patients with kidney cancer that has spread to other places in the body (metastatic) or cannot be removed by surgery. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Ascorbic acid may help pazopanib hydrochloride stop tumor growth and improve treatment survival. Giving pazopanib hydrochloride and ascorbic acid may work better in treating patients with kidney cancer.

Timeline

Start
2018-02-16
Primary completion
2021-03-13
Completion
2021-03-13

Outcome

Missed primary endpoint

Stopped (Business): “Due to loss of funding from the private foundation source”

registry analysis (superiority test); Arm A (Pazopanib Hydrochloride, Ascorbic Acid) vs Arm B (Pazopanib Hydrochloride); p = 1.0; Fisher Exact NCT03334409 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Pazopanib Small molecule 800 mg Oral
Subject Vitamin C Other / unclassified 1 g/kg Intravenous