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

Study acronym: Enhancer
StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated March 21, 2025 (before its estimated June 20, 2025 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 6 of 6 sites
    v7
  2. Primary completion date: Nov 8, 2023 to Jun 20, 2025v6
  3. Site details revised at 4 of 6 sitesv5
  4. Study sites: 2 to 6v4
  5. Study title expanded, about 2 wordsv3
  6. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 2
    • Start date changed from estimate of May 8, 2023 to May 29, 2023
    • Study title shortened, about 1 word
    v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT05809830
Lead Sponsor Grupo Espanol de Investigacion en Sarcomas
Conditions
(from sponsor)		 Advanced Soft-tissue Sarcoma
Enrollment 152 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov