drugset / Trial / NCT03368963

TAS102 in Combination With NAL-IRI in Advanced GI Cancers

NCT03368963

Phase 1/2 Active not recruiting 64 enrolled Emory University Ipsen · collabTaiho Oncology, Inc. · collab
NaSingle-groupOpen-labelTreatment

Summary

This phase I/II trial studies the best dose and how well trifluridine/tipiracil hydrochloride combination agent TAS-102 (TAS-102) and nanoliposomal irinotecan work in treating patients with gastrointestinal cancers that have spread to other places in the body (metastatic) or cannot be removed by surgery. Drugs used in the chemotherapy, such as trifluridine/tipiracil hydrochloride combination agent TAS-102 and nanoliposomal irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Timeline

Start
2018-01-30
Primary completion
2025-06-28
Completion
2025-11-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Irinotecan Small molecule Intravenous
Subject Tipiracil Small molecule Oral
Subject Trifluridine Small molecule Oral