NCT03810742 is a Phase 1 clinical trial of Nanoliposomal Irinotecan in Refractory Solid Tumors, sponsored by PharmaEngine.

Who is sponsoring NCT03810742?

NCT03810742 is sponsored by PharmaEngine.

What drugs are being tested in NCT03810742?

Interventions in NCT03810742: Nanoliposomal Irinotecan.

What condition does NCT03810742 study?

NCT03810742 studies Refractory Solid Tumors.

Is NCT03810742 still recruiting?

NCT03810742 is currently completed. Last updated 18 November 2023.

Last reviewed 2023-11-18 · How we verify

NCT03810742

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Nanoliposomal Irinotecan (Nal-IRI, ONIVYDE®) in Combination With TAS-102 (LONSURF®) in Refractory Solid Tumors

Completed Phase 1 Last updated 18 November 2023

What this trial tests

Phase 1 trial testing Nanoliposomal Irinotecan in Refractory Solid Tumors in 44 participants. Completed in 25 October 2023.

Timeline

5 March 2019

Primary endpoint
4 May 2022

25 October 2023

Quick facts

Lead sponsor	PharmaEngine
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	44
Start date	5 March 2019
Primary completion	4 May 2022
Estimated completion	25 October 2023
Sites	2 locations across Taiwan

Drugs / interventions tested

Nanoliposomal Irinotecan — full drug profile →

Conditions studied

Refractory Solid Tumors — all drugs for Refractory Solid Tumors →

Sponsor

PharmaEngine — full company profile →

Who can join

Adults 20 to 70, any sex, with Refractory Solid Tumors. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The study is to explore the combination of nal-IRI and TAS-102, which is expected to be an effective regimen that could be applied to various cancers

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

PEGylated therapeutics in the clinic.
Gao Y, Joshi M, Zhao Z, Mitragotri S. · · 2024 · cited 133× · PMID 38193121 · DOI 10.1002/btm2.10600
Substances of Natural Origin in Medicine: Plants vs. Cancer.
Gielecińska A, Kciuk M, Mujwar S, Celik I, et al · · 2023 · cited 39× · PMID 37048059 · DOI 10.3390/cells12070986

Verify or expand the search:

Other trials of Nanoliposomal Irinotecan

Trials testing the same drug.

NCT06219941 — AZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2 · Phase 2 · recruiting
NCT04005339 — NAPOLI-2: Fluorouracil, Leucovorin, and Nanoliposomal Irinotecan in Biliary Cancer · Phase 2 · active not recruiting
NCT03368963 — TAS102 in Combination With NAL-IRI in Advanced GI Cancers · Phase 1, PHASE2 · active not recruiting
NCT03119064 — BrUOG 329 Onivyde & Metronomic Temozolomide in Recurrent Glioblastoma · Phase 1, PHASE2 · terminated

Other recruiting trials for Refractory Solid Tumors

Currently open trials in the same condition.

NCT06150365 — Personalized KSX01-TCRT in Patients With Advanced Solid Tumors · EARLY_PHASE1 · recruiting
NCT06006273 — A Phase Ib Trial of Eribulin in Combination With Irinotecan and Temozolamide in Children With Relapsed or Refractory Sol · Phase 1 · recruiting
NCT05811975 — KSX01-TCRT Injection Project in Solid Tumors · EARLY_PHASE1 · recruiting
NCT05539833 — KSH01-TCRT Solid Tumors · EARLY_PHASE1 · recruiting
NCT03739827 — Natural History and Biospecimen Acquisition for Children and Adults With Rare Solid Tumors · recruiting

Other PharmaEngine trials

Trials by the same sponsor.

NCT05983523 — A Study of PEP07 (Checkpoint Kinase 1 Inhibitor) in Patients with Advanced or Metastatic Solid Tumors · Phase 1 · recruiting
NCT05659732 — A Study of PEP07 (Checkpoint Kinase 1 Inhibitor) in Patients With Advanced Cancer · Phase 1 · recruiting
NCT02901483 — A Study of PEP503 With Radiotherapy in Combination With Concurrent Chemotherapy for Patients With Head and Neck Cancer · Phase 1, PHASE2 · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03810742 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by PharmaEngine
Last refreshed: 18 November 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03810742.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing