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Phase I/II of LB-100 Plus Doxorubicin vs. Doxorubicin Alone in First Line of Advanced Soft Tissue Sarcomas — Enhancer  

Advanced Soft-tissue Sarcoma Clinical Trial

Official title:
Phase I/II Randomized Trial of LB-100 Plus Doxorubicin vs. Doxorubicin Alone in First Line of Advanced Soft Tissue Sarcomas

Clinical Trial Summary

A Phase I dose-finding stage for the LB-100 plus doxorubicin combination is planned for an initial set of 9-18 patients (21-day cycles). After that, in the Phase II part, patients will be randomized (ratio 1:1) to either the experimental arm (LB-100 plus doxorubicin combination) or the control arm (doxorubicin alone) to, comparatively, evaluate the efficacy of the LB-100 plus doxorubicin combination vs. doxorubicin alone

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05809830
Study type Interventional
Source Grupo Espanol de Investigacion en Sarcomas
Contact Patricio Ledesma
Phone +34 971 439 900
Email ensayos@sofpromed.com
Status Recruiting
Phase Phase 1/Phase 2
Start date May 29, 2023
Completion date May 8, 2026
View Details
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