NCT04074343

TAS-102 and Irinotecan in 2L+ Gastric and Gastroesophageal Adenocarcinoma

A Phase Ib Multicenter Study of TAS-102 in Combination With Irinotecan in Patients With Advanced Recurrent or Unresectable Gastric and Gastroesophageal Adenocarcinoma After at Least One Line of Treatment With a Fluoropyrimidine and Platinum Containing Regimen

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of California, Irvine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase Ib single-arm, open-label clinical trial determining the feasibility and efficacy of TAS-102 and irinotecan in subjects with advanced gastric and gastroesophageal adenocarcinoma. These are subjects who are not candidates for curative treatments and who have received at least one prior line of chemotherapy with a fluoropyrimidine and platinum agent.

Detailed description

Treatment on study will be administered in 14 day cycles.

Conditions

• Gastric Adenocarcinoma
• GastroEsophageal Cancer

Interventions

Type	Name	Description
DRUG	TAS-102	Given PO
DRUG	Irinotecan	Given IV

Timeline

• Start date: 2019-08-26
• Primary completion: 2021-07-14
• Completion: 2022-07-21
• First posted: 2019-08-30
• Last updated: 2024-02-02
• Results posted: 2024-02-02

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study