A Study of Olaratumab (LY3012207) in Participants With Soft Tissue Sarcoma
NCT ID: NCT02783599
Last Updated: 2019-08-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
51 participants
INTERVENTIONAL
2016-10-11
2018-07-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Olaratumab + Doxorubicin
Cycle 1: Olaratumab 20 milligram per kilogram (mg/kg) given intravenously (IV) on Day 1 and Day 8 (21 day cycle).
Cycle 2: Olaratumab 20 mg/kg given IV on Day 1 and Day 8 plus doxorubicin 75 mg/m2 given IV on Day 1 (21 day cycle).
Cycle 3 through Cycle 7: Olaratumab 15 mg/kg given IV on Day 1 and Day 8 plus doxorubicin 75 mg/m2 given IV on Day 1 (21 day cycles).
Olaratumab
Administered IV
Doxorubicin
Administered IV
Olaratumab + Radiotherapy Addendum
Olaratumab given IV on Day 1 and Day 8 (21 day cycle) concurrently with radiotherapy.
Radiotherapy addendum was not implemented.
Olaratumab
Administered IV
External Beam Radiotherapy
Interventions
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Olaratumab
Administered IV
Doxorubicin
Administered IV
External Beam Radiotherapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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USC/Norris Comp Cancer Center
Los Angeles, California, United States
Yale University School of Medicine
New Haven, Connecticut, United States
All Children's Hospital
St. Petersburg, Florida, United States
Moffitt Cancer Center & Research Inst
Tampa, Florida, United States
Kansas City Cancer Center
Overland Park, Kansas, United States
Washington University Medical Center
St Louis, Missouri, United States
Levine Children's Hospital
Charlotte, North Carolina, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Mary Crowley Cancer Research
Dallas, Texas, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Lyon, , France
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Milan, , Italy
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Barcelona, , Spain
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Seville, , Spain
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
London, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Click here for more information about this study: A Study of Olaratumab (LY3012207) in Participants With Soft Tissue Sarcoma
Other Identifiers
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I5B-MC-JGDM
Identifier Type: OTHER
Identifier Source: secondary_id
2015-005018-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
15840
Identifier Type: -
Identifier Source: org_study_id
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