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

Sponsor
PharmaEngine
Study ID
NCT03810742
Phase
PHASE1
Status
Completed

Conditions

  • Refractory Solid Tumors

Eligibility Criteria

Sex
ALL
Age
20 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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

Key Dates

Start date
Mar 5, 2019
Status verified
Nov 2023
Primary completion
May 4, 2022
Completion
Oct 25, 2023

Study Design

Enrollment
44 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Nanoliposomal Irinotecan + TAS-102
    different dosage combination by Nanoliposomal Irinotecan (nal-IRI, ONIVYDE®) in Combination with TAS-102 (LONSURF®)

Primary Outcome Measure

Determination of Dose Limiting Toxicities (DLT) [ Time Frame: 12 months ]

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