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



Status:Completed
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/24/2019
Start Date:October 11, 2016
End Date:July 4, 2018

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A Phase 1b Trial to Assess the Modulation of Biological Markers in Patients With Potentially Resectable Soft Tissue Sarcoma Treated With Olaratumab Monotherapy Followed by Olaratumab Plus Doxorubicin Combination Therapy

The purpose of this study is to evaluate potential biomarkers and method of action, efficacy
and safety of olaratumab in participants with soft tissue sarcoma (STS).


Inclusion Criteria:

- Have a histologically confirmed diagnosis of STS for which olaratumab and doxorubicin
would be appropriate therapy. Participants with a diagnosis of Grade 1 liposarcoma are
eligible if there is histological or radiographic evidence of evolution to more
aggressive disease. Participants with Kaposi's sarcoma and gastrointestinal stromal
tumors (GIST) will be excluded. Participants must have potentially resectable disease
(as assessed by the study investigator) and have a primary tumor lesion deemed
amenable to serial biopsy.

- For radiotherapy addendum only: Have a histologically confirmed diagnosis of STS of
the extremities, Grade 2 or 3, >5 centimeters, for which olaratumab and radiotherapy
would be appropriate therapy. Participants with Kaposi's sarcoma, GIST or myxoid
liposarcoma will be excluded.

- Have consented to undergo mandatory serial peripheral whole blood and tumor tissue
sampling.

Exclusion Criteria:

- Have active central nervous system (CNS) or leptomeningeal metastasis (brain
metastasis) at the time of enrollment. Participants with a history of a CNS metastasis
previously treated with curative intent (for example, stereotactic radiation or
surgery) that have not progressed on follow-up imaging, have been asymptomatic for at
least 60 days and are not receiving systemic corticosteroids and or/anticonvulsants,
are eligible. Participants with signs or symptoms of neurological compromise should
have appropriate radiographic imaging performed before enrollment to rule out brain
metastasis.

- Have received prior treatment with doxorubicin, epirubicin, idarubicin, and/or other
anthracyclines or anthracenediones; the participant has received treatment with
olaratumab or has participated in a prior olaratumab trial.

- For radiotherapy addendum only: Have received previous radiotherapy in the primary
tumor lesion and/or prior treatment with olaratumab or has participated in a prior
olaratumab trial.
We found this trial at
10
sites
Los Angeles, California 90033
Principal Investigator: James Hu
Phone: 323-865-3538
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: Scott Borinstein
Phone: 615-936-1762
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Charlotte, North Carolina 28204
Principal Investigator: Chad Jacobsen
Phone: 704-381-6810
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7777 Forest Lane
Dallas, Texas 75230
Principal Investigator: Maurizio Ghisoli
Phone: 972-566-3090
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Lyon,
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333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
Principal Investigator: Hari Deshpande
Phone: 203-737-1600
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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Overland Park, Kansas 66210
Principal Investigator: Benjamin Powers
Phone: 913-234-0400
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Saint Louis, Missouri 63110
Principal Investigator: Brian Van Tine
Phone: 314-747-8475
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Saint Petersburg, Florida 33701
Principal Investigator: Peter Shaw
Phone: 727-767-2423
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Tampa, Florida 33612
Principal Investigator: Andrew Brohl
Phone: 813-745-3242
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