TAS102 in Combination With NAL-IRI in Advanced GI Cancers

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT03368963
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Jan 30, 2018
Status verified
Jan 2025
Primary completion
Jun 28, 2025
Completion
Nov 28, 2025

Study Design

Enrollment
64 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (Nal-IRI, TAS-102)
    Patients receive nanoliposomal irinotecan IV over 90 minutes on day 1 and combination of trifluridine/tipiracil hydrochloride combination agent TAS-102 PO BID on days 1-5. Cycles repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Incidence of adverse events of trifluridine/tipiracil hydrochloride combination agent TAS-102 in combination with nanoliposomal irinotecan [ Time Frame: Up to 3 years after end of treatment ]

Locations (3)

FacilityCityStateZIPSite coordinators
Emory Saint Joseph's HospitalAtlantaGeorgia30342-
Emory University Hospital MidtownAtlantaGeorgia30308-
Emory University Hospital/Winship Cancer InstituteAtlantaGeorgia30322-

Find similar trials in Atlanta, GA

By research site
Emory Saint Joseph's Hospital· Atlanta, GAEmory University Hospital Midtown· Atlanta, GAEmory University Hospital/Winship Cancer Institute· Atlanta, GA

Related Studies