TAS102 in Combination With NAL-IRI in Advanced GI Cancers
Active, not recruiting · Phase 1, Phase 2 · NCT03368963
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
At a glance
- Research payments reported, 2025
- $469,477
- U.S. investigators named
- 2
- Sites paid
- 2
- Planned or actual enrollment
- 64
About the trial
- Sponsor
- Emory University (with Taiho Oncology, Inc., Ipsen)
- Tested
- Nanoliposomal Irinotecan (drug), Trifluridine and Tipiracil Hydrochloride (drug)
- Dates
- Started 2018-01-30; completion 2025-11-28
- Results posted
- Not yet
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.
From ClinicalTrials.gov, last updated 2025-01-07. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Ipsen Biopharmaceuticals, Inc reported $469,477 in research payments for this study in 2025 (6 payments).
Products named: Onivyde, Tazverik
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Olatunji B. Alese, M.D. Medical Oncology · Atlanta, GA
- Dustin A. Deming, M.D. Medical Oncology · Madison, WI
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.