A Study of Olaratumab (LY3012207) in Participants With Advanced Soft Tissue Sarcoma (ANNOUNCE 2)

I5B-MC-JGDL -

The main purpose of this study is to evaluate the safety and efficacy of two anti-cancer drugs (gemcitabine and docetaxel) with and without the study drug known as olaratumab in participants with advanced soft tissue sarcoma (STS) or STS that has spread to another part(s) of the body.

Trial Summary

Age Range
≥16 years
Conditions the trial is for
Sarcoma
What the trial is testing?
Docetaxel, Gemcitabine, Olaratumab
Could I receive a Placebo?
Yes
Enrollment Goal
310
Trial Dates
Mar 1, 2016 - Apr 27, 2021
How long will I be in the trial?
Your participation could last >12 months depending on how you and your tumor respond.
Trial Phase
II

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 completed all previous therapies more than 3 weeks before the first dose of study drug

  • Participant must be willing to provide tumor tissue

Participants Must Not:

  • Participant must not be diagnosed with gastrointestinal stromal tumor (GIST) or Kaposi sarcoma

  • Participant must not have active central nervous system or brain metastasis at the start of the study

  • Participant must not have received prior treatment with gemcitabine or docetaxel (this includes participants previously enrolled in I5B-MC-JGDJ (NCT02451943)

  • Participant must not have planned elective surgery or will require surgery during study participation

  • Female participant must not be pregnant or breastfeeding

  • Participant must not have active fungal, bacterial, and/or known viral infection including HIV or viral (A, B, or C) hepatitis

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