Trials / Active Not Recruiting

Active Not RecruitingNCT03368963

TAS102 in Combination With NAL-IRI in Advanced GI Cancers

A Phase I/II Study of Trifluridine/Tipiracil (TAS102) in Combination With Nanoliposomal Irinotecan (NAL-IRI) in Advanced GI Cancers

Status: Active Not Recruiting
Phase: Phase 1 / Phase 2
Study type: Interventional
Enrollment: 64 (estimated)

Sponsor: Emory University · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. Determine the recommended phase II dose for the combination of TAS-102 and nanoliposomal irinotecan (nanoliposomal \[nal\]-IRI). (Phase I) II. Evaluate the activity of the combination of TAS102 and nal-IRI in previously treated patients with metastatic colorectal cancer and pancreatic cancer. (Phase II) SECONDARY OBJECTIVES: I. Define the toxicity profile of the combination of TAS-102 and nal-IRI. II. Evaluate the response duration, progression free, and overall survival of the combination of TAS-102 and nal-IRI in previously treated patients with metastatic colorectal cancer and pancreatic cancer. OUTLINE: This is a phase I, dose-escalation study followed by a phase II study. Patients receive nanoliposomal irinotecan intravenously (IV) over 90 minutes on day 1 and trifluridine/tipiracil hydrochloride combination agent TAS-102 orally (PO) twice daily (BID) on days 1-5. Cycles repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 30 days and then every 8 or 12 weeks thereafter.

Conditions

Interventions

Type	Name	Description
DRUG	Nanoliposomal Irinotecan	Given IV
DRUG	Trifluridine and Tipiracil Hydrochloride	Given PO

Timeline

Start date: 2018-01-30
Primary completion: 2025-06-28
Completion: 2025-11-28
First posted: 2017-12-11
Last updated: 2025-01-07

Locations

3 sites across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT03368963. Inclusion in this directory is not an endorsement.