drugset / Trial / NCT02446795

Isoquercetin as an Adjunct Therapy in Patients With Kidney Cancer Receiving First-line Sunitinib: a Phase I/II Trial

NCT02446795

RandomizedParallel-groupTriple-blindTreatment

Summary

Advanced renal cell carcinoma is invariably fatal, with a life expectancy of 2-3 years since diagnosis. Sunitinib is the standard first-line treatment for this condition, but it is associated to multiple side effects, with fatigue being reported in 51-63% of patients. As sunitinib-induced fatigue is likely to be mediated by inhibition of AMPk function, the investigators hypothesize that isoquercetin, which is hydrolyzed in vivo to quercetin, a known AMPk activator, is able to reduce fatigue in kidney cancer patients taking sunitinib.

Timeline

Start
2016-11
Primary completion
2017-12
Completion
2017-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Isoquercetin Small molecule 225 mg
Subject Isoquercetin Small molecule 450 mg
Background Sunitinib Small molecule 50 mg Oral

Indications