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

NCT05809830 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2025-03-21

No results posted yet for this study

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

Conditions

  • Advanced Soft-tissue Sarcoma

Interventions

DRUG

LB-100 plus Doxorrubicin

In Phase one the intervention will be LB-100 plus Doxorrubicin. The experimental arm in Phase II will also be LB-100 plus Doxorrubicin

DRUG

Doxorubicin

The control arm in Phase II will be Doxorrubicin alone

Sponsors & Collaborators

  • Grupo Espanol de Investigacion en Sarcomas

    lead OTHER

Principal Investigators

  • Javier Martín Broto · Hospital Universitario Fundación Jiménez Díaz

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-29
Primary Completion
2025-06-20
Completion
2026-05-08
FDA Drug
Yes

Countries

  • Spain

Study Locations

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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 NCT05809830 on ClinicalTrials.gov