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TAS102 in Combination With NAL-IRI in Advanced GI Cancers

NCT03368963 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2025-01-07

No results posted yet for this study

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.

Conditions

  • Colorectal Adenocarcinoma
  • Gastric Adenocarcinoma
  • Metastatic Pancreatic Adenocarcinoma
  • Non-Resectable Cholangiocarcinoma
  • Stage IV Colorectal Cancer
  • Stage IV Gastric Cancer
  • Stage IV Pancreatic Cancer
  • Stage IVA Colorectal Cancer
  • Stage IVB Colorectal Cancer
  • Stage III Colorectal Cancer
  • Stage III Gastric Cancer
  • Stage III Pancreatic Cancer
  • Unresectable Digestive System Adenocarcinoma
  • Unresectable Pancreatic Carcinoma

Interventions

DRUG

Nanoliposomal Irinotecan

Given IV

DRUG

Trifluridine and Tipiracil Hydrochloride

Given PO

Sponsors & Collaborators

  • Taiho Oncology, Inc.

    collaborator INDUSTRY

  • Ipsen

    collaborator INDUSTRY

  • Emory University

    lead OTHER

Principal Investigators

  • Olatunji B. Alese, MD · Emory University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-30
Primary Completion
2025-06-28
Completion
2025-11-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03368963 on ClinicalTrials.gov