A Phase I Study of TAS-102 in Patients With Advanced Solid Tumors With Renal Impairment

Phase 1 Completed 43 enrolled Taiho Oncology, Inc.

Non-randomizedSingle-groupOpen-labelTreatment

Summary

Study to evaluate the safety, tolerability, and pharmacokinetics of TAS-102 in patients with advanced solid tumors and varying degrees of renal impairment.

Timeline

Start: 2015-01
Primary completion: 2019-06-19
Completion: 2019-06-19

Publications

Saif MW, Becerra CR, Fakih MG, Sun W, Popovic L, Krishnamurthi S, George TJ, Rudek MA, Shepard DR, Skopek J, Sramek V, Zaric B, Yamamiya I, Benhadji KA, Hamada K, He Y, Rosen L. A phase I, open-label study evaluating the safety and pharmacokinetics of trifluridine/tipiracil in patients with advanced solid tumors and varying degrees of renal impairment. Cancer Chemother Pharmacol. 2021 Sep;88(3):485-497. doi: 10.1007/s00280-021-04308-z. Epub 2021 Jun 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	TAS-102	Small molecule	20 mg/m2	Oral
Subject	TAS-102	Small molecule	35 mg/m2	Oral

A Phase I Study of TAS-102 in Patients With Advanced Solid Tumors With Renal Impairment

Summary

Timeline

Publications

Drugs

Indications