drugset / Trial / NCT02446795
Isoquercetin as an Adjunct Therapy in Patients With Kidney Cancer Receiving First-line Sunitinib: a Phase I/II Trial
Phase 1/2
Unknown
104 enrolled
Consorzio Oncotech
Clinical Research Technology S.r.l. · collabQuercegen Pharmaceuticals · collab
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
Publications
- Results Aparicio LM, Pulido EG, Gallego GA. Sunitinib-induced asthenia: from molecular basis to clinical relief. Cancer Biol Ther. 2011 Nov 1;12(9):765-71. doi: 10.4161/cbt.12.9.18138.
- Results Di Lorenzo G, Porta C, Bellmunt J, Sternberg C, Kirkali Z, Staehler M, Joniau S, Montorsi F, Buonerba C. Toxicities of targeted therapy and their management in kidney cancer. Eur Urol. 2011 Apr;59(4):526-40. doi: 10.1016/j.eururo.2011.01.002. Epub 2011 Jan 14.
- Results Russo GL, Russo M, Ungaro P. AMP-activated protein kinase: a target for old drugs against diabetes and cancer. Biochem Pharmacol. 2013 Aug 1;86(3):339-50. doi: 10.1016/j.bcp.2013.05.023. Epub 2013 Jun 6.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Isoquercetin | Small molecule | 225 mg | — |
| Subject | Isoquercetin | Small molecule | 450 mg | — |
| Background | Sunitinib | Small molecule | 50 mg | Oral |