Soft Tissue Sarcoma

Active not recruiting

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

I5B-MC-JGDJ - ClinicalTrials.gov - NCT02451943

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.
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
Email
Active not recruiting

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

I5B-MC-JGDJ - ClinicalTrials.gov - NCT02451943

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.
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
Email

Key Requirements

Age :

18+

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

18+

Sex

All

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

Trial Summary

Conditions the trial is for

Soft Tissue Sarcoma

What the trial is testing?

Olaratumab/Placebo, Doxorubicin

Could I receive a Placebo?

yes

Enrollment Goal

460

Trial Dates

September 2015 - March 2021

Trial Phase

3

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

18+

Sex

All

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

Trial Summary

Conditions the trial is for

Soft Tissue Sarcoma

What the trial is testing?

Olaratumab/Placebo, Doxorubicin

Could I receive a Placebo?

yes

Enrollment Goal

460

Trial Dates

September 2015 - March 2021

Trial Phase

3

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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?