Completed Enrollment

A Study of Doxorubicin Plus Olaratumab (LY3012207) in Participants With Advanced or Metastatic Soft Tissue Sarcoma (ANNOUNCE)

I5B-MC-JGDJ -

The main purpose of this study is to evaluate the efficacy of the combination of doxorubicin plus the study drug known as olaratumab versus doxorubicin plus placebo in participants with advanced or metastatic soft tissue sarcoma.

Trial Summary

Age Range
≥18 years
Conditions the trial is for
Soft Tissue Sarcoma
What the trial is testing?
Olaratumab/Placebo, Doxorubicin
Could I receive a Placebo?
Yes
Enrollment Goal
509
Trial Dates
Sep 14, 2015 - Jul 2024
How long will I be in the trial?
Your participation in this trial could last >8 months, depending on how you and your tumor respond.
Trial Phase
III

Key Requirements

Clinical trials have inclusion and exclusion requirements to determine which individuals qualify for participation. Listed below are key requirements for this clinical trial, but there may be additional requirements to qualify.

Participants Must:

  • Participant must have confirmed diagnosis of advanced unresectable or metastatic soft tissue sarcoma, that is not treatable with surgery or radiotherapy

  • Participant must consent to provide archived formalin-fixed paraffin embedded (FFPE) tumor tissue or undergo a pre-treatment re-biopsy of primary or metastatic tumor tissue

Participants Must Not:

  • Participant must not have any abnormal function of the heart (cardiac dysfunction)

  • Participant must not have any planned or elective surgery

  • Participant must not have prior treatment with olaratumab, doxorubicin, epirubicin, idarubicin, and/or other anthracyclines and anthracenediones

  • Participant must not have had prior radiotherapy of the mediastinal/pericardial area or whole pelvis radiation

  • Female participant must not be pregnant or breastfeeding

  • Females of child-bearing potential and males must agree to use highly effective contraceptive during the trial and up to 3 months following the last dose of study drug

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