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TLD-1, a Novel Liposomal Doxorubicin, in Patients With Advanced Solid Tumors

NCT03387917 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2024-12-02

No results posted yet for this study

Summary

TLD-1 is a novel liposomal formulation of doxorubicin (PEG surface) that compared favorably to conventional liposomal formulations of doxorubicin including Caelyx® in preclinical in vivo models. Particle features including size, charge distribution, lipid composition and drug release add up to a considerably altered particle behavior compared to Caelyx®, potentially explaining the lack of hand-foot-syndrome in respective animal models. Preclinical evaluation confirmed TLD-1 to be a promising new and innovative formulation of doxorubicin with promising activity and good tolerability.

Conditions

Interventions

DRUG

TLD-1

TLD-1 is a new liposomal formulation of the anthracycline doxorubicin.

DRUG

Caelyx

Caelyx is a liposomal formulation of the anthracycline doxorubicin

Sponsors & Collaborators

  • Swiss Cancer Institute

    lead OTHER

Principal Investigators

  • Dagmar Hess, MD · Cantonal Hospital of St. Gallen

  • Anastasios Stathis, MD · IOSI, Ospedale San Giovanni

  • Markus Jörger, Prof · Cantonal Hospital of St. Gallen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-12
Primary Completion
2023-09-22
Completion
2023-12-22

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

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 NCT03387917 on ClinicalTrials.gov