Active not recruiting

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

I5B-MC-JGDL - ClinicalTrials.gov - NCT02659020

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.
How long will I be in the trial?
Your participation could last >12 months depending on how you and your tumor respond.
Email
Active not recruiting

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

I5B-MC-JGDL - ClinicalTrials.gov - NCT02659020

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.
How long will I be in the trial?
Your participation could last >12 months depending on how you and your tumor respond.
Email

Key Requirements

Age :

16+

Sex:

All

Key Requirements

Use the following checklist to help determine if this trial may be a good fit for you. Place a checkmark next to each criteria that you successfully meet.

Age

16+

Sex

All

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

Trial Summary

Conditions the trial is for

Soft Tissue Sarcoma

What the trial is testing?

Olaratumab (LY3012207) + Gemcitabine + Docetaxel, Placebo + Gemcitabine + Docetaxel

Could I receive a Placebo?

yes

Enrollment Goal

310

Trial Dates

March 2016 - August 2021

Trial Phase

1

Enter your postal code to find the nearest site

Key Requirements

Use the following checklist to help determine if this trial may be a good fit for you. Place a checkmark next to each criteria that you successfully meet.

Age

16+

Sex

All

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

Trial Summary

Conditions the trial is for

Soft Tissue Sarcoma

What the trial is testing?

Olaratumab (LY3012207) + Gemcitabine + Docetaxel, Placebo + Gemcitabine + Docetaxel

Could I receive a Placebo?

yes

Enrollment Goal

310

Trial Dates

March 2016 - August 2021

Trial Phase

1

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Trial Locations

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Soft Tissue Sarcoma Resources

Clinical Trial Participation: What to Expect

Clinical Trial Participation: What to Expect

A clinical trial is a scientific study in people that helps to determine if and how a drug or therapy works. These can also be called clinical studies, or clinical research. Clinical research helps us answer specific questions about an investigational drug , such as: Is it effective? Is it more effective than another established treatment? Is it safe and/or what are its side effects?