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A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Doxorubicin Plus Olaratumab Versus Doxorubicin Plus Placebo in Patients With Advanced or Metastatic Soft Tissue Sarcoma

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Trial Profile

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Doxorubicin Plus Olaratumab Versus Doxorubicin Plus Placebo in Patients With Advanced or Metastatic Soft Tissue Sarcoma

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 17 Jul 2025

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At a glance

  • Drugs Olaratumab (Primary) ; Dexrazoxane; Doxorubicin
  • Indications Haemangiosarcoma; Leiomyosarcoma; Liposarcoma; Myxoid liposarcoma; Nerve sheath neoplasms; Rhabdomyosarcoma; Sarcoma; Soft tissue sarcoma; Synovial sarcoma
  • Focus Registrational; Therapeutic Use
  • Acronyms ANNOUNCE
  • Sponsors Eli Lilly and Company (India) Pvt. Ltd; Eli Lilly Japan

Most Recent Events

  • 07 Oct 2024 Status changed from active, no longer recruiting to completed.
  • 17 Jan 2024 Planned End Date changed from 31 Dec 2024 to 31 Jul 2024.
  • 24 Oct 2023 Results (n=632) assessing the effect of doxorubicin dose on survival using individual data from the phase II and phase III studies exploring olaratumab in advanced soft tissue sarcoma, presented at the 48th European Society for Medical Oncology Congress.

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