Olaratumab (LY3012207) Patient Access for Soft Tissue Sarcoma

December 11, 2024 updated by: Eli Lilly and Company

An Open-Label, Multi-Center Patient Access Program of Olaratumab for the Treatment of Soft Tissue Sarcoma

The purpose of this study is to continue to provide olaratumab to eligible patients who are currently receiving olaratumab commercially for the treatment of soft tissue sarcoma (STS).

Study Overview

Status

Approved for marketing

Conditions

Intervention / Treatment

Study Type

Expanded Access

Expanded Access Type

  • Individual Patients

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
    • Oberösterreich
      • Linz, Oberösterreich, Austria, 4020
        • Ordensklinikum Linz GmbH Elisabethinen
      • Linz, Oberösterreich, Austria, 4021
        • Kepler Universitätsklinikum GmbH, Med Campus III
  • Brazil
    • Bahia
      • Salvador, Bahia, Brazil, 40170-010
        • CLION - Clínica de Oncologia
    • Paraná
      • Londrina, Paraná, Brazil, 86050-435
        • Instituto Londrina de Radioterapia
  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H2V 2E2
        • CHUM
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4T 7T1
        • Allan Blair Cancer Centre
  • Hungary
      • Budapest, Hungary, 1122
        • National Institute of Oncology
    • Szabolcs-Szatmár-Bereg
      • Nyiregyhaza, Szabolcs-Szatmár-Bereg, Hungary, 4400
        • Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Josa Andras Oktatokorhaz
  • India
    • Karnataka
      • Bangalore, Karnataka, India, 560027
        • Healthcare Global Enterprises Limited (HCG)
  • Italy
      • Bologna, Italy, 40138
        • IRCCS - AOU di Bologna
      • Trento, Italy, 38122
        • Ospedale Santa Chiara Di Trento
    • Veneto
      • Padova, Veneto, Italy, 35128
        • Istituto Oncologico Veneto IRCCS
  • Korea, Republic of
      • Iksan-si, Jeonlabuk-do, Korea, Republic of, 54538
        • Wonkwang University Hospital
    • Incheon
      • Namdong-gu, Incheon, Korea, Republic of, 21565
        • Gachon University Gil Medical Center
    • Incheon-gwangyeoksi [Incheon]
      • Incheon, Incheon-gwangyeoksi [Incheon], Korea, Republic of, 22332
        • Inha University Hospital
    • Kyǒnggi-do
      • Seongnam, Kyǒnggi-do, Korea, Republic of, 13620
        • Seoul National University Bundang Hospital
    • Pusan-Kwangyǒkshi
      • Busan, Pusan-Kwangyǒkshi, Korea, Republic of, 49241
        • Pusan National University Hospital
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
      • Madrid, Spain, 28050
        • Hospital Madrid Norte Sanchinarro
      • Madrid, Spain, 28033
        • Centro Oncológico MD Anderson
      • Madrid, Spain, 28022
        • Cl. Universitaria Navarra
      • Segovia, Spain, 40002
        • Gerencia de Asistencia Sanitaria de Segovia_Hospital General de Segovia
      • Sevilla, Spain, 41013
        • Hospital Universitario Virgen del Rocio
      • Valencia, Spain, 46009
        • Fundación Instituto Valenciano de Oncología
      • Valencia, Spain, 46026
        • Hospital Universitario La Fe de Valencia
    • La Laguna
      • Tenerife, La Laguna, Spain, 38320
        • Hospital Universitario de Canarias
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Hospital de Navarra
    • Santa Cruz De Bezana
      • Cantabria, Santa Cruz De Bezana, Spain, 39109
        • Clínica Mompia
  • Taiwan
      • Taichung, Taiwan, 40447
        • China Medical University Hospital
  • United Kingdom
      • Birmingham, United Kingdom, B15 2WB
        • Queen Elizabeth Hospital Birmingham
      • Cambridge, United Kingdom, CB2 0QQ
        • Cambridge University Hospitals NHS Foundation Trust
    • Greater Manchester
      • Manchester, Greater Manchester, United Kingdom, M20 4BX
        • The Christie NHS Foundation Trust
    • Scotland
      • Dundee, Scotland, United Kingdom, DD1 9SY
        • Ninewells Hospital
  • United States
    • Arizona
      • Glendale, Arizona, United States, 85306
        • Ironwood Cancer & Research Centers
    • California
      • Greenbrae, California, United States, 94904
        • Marin Specialty Care, Inc
      • Los Angeles, California, United States, 90027
        • Kaiser Permanente Los Angeles Medical Center
      • Los Angeles, California, United States, 90034
        • Kaiser Permanente West Los Angeles
      • Los Angeles, California, United States, 90025
        • The Angeles Clinic & Research Institute
      • Moreno Valley, California, United States, 92555
        • Kaiser Permanente Moreno Valley
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Health Hospital
      • Fort Collins, Colorado, United States, 80528
        • UCHealth Cancer Center
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Baptist MD Anderson Cancer Center
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic in Florida
      • Ocala, Florida, United States, 34474
        • Ocala Oncology, P.A.
      • Orlando, Florida, United States, 32806
        • Orlando Health UF Health Cancer Center
      • Orlando, Florida, United States, 32804
        • Florida Cancer Specialists
      • Sarasota, Florida, United States, 34236
        • Florida Cancer Specialists
      • Tamarac, Florida, United States, 33321
        • Oncology-Hematology Associates of West Broward
    • Georgia
      • Athens, Georgia, United States, 30606
        • Northside Hospital
      • Tifton, Georgia, United States, 31794
        • Tift Regional Health System Anita Stewart Oncology Center
    • Idaho
      • Coeur d'Alene, Idaho, United States, 83814
        • Beacon Cancer Care
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Peoria, Illinois, United States, 61615
        • Illinois Cancer Care
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Hematology Oncology Clinic
      • New Orleans, Louisiana, United States, 70121
        • Alton Ochsner Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland, Baltimore
      • Baltimore, Maryland, United States, 21287
        • SKCCC at Johns Hopkins
      • Glen Burnie, Maryland, United States, 21061
        • Baltimore Washington Health Services
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • University of Massachusetts Medical Center
    • Michigan
      • Clinton Township, Michigan, United States, 48038
        • Henry Ford Macomb Hospital
      • Grand Rapids, Michigan, United States, 49503
        • Cancer & Hematology Centers of Western Michigan
    • Minnesota
      • Duluth, Minnesota, United States, 55805
        • St. Luke's Hospital of Duluth
      • Minneapolis, Minnesota, United States, 55455
        • Masonic Cancer Center, University
    • Mississippi
      • Jackson, Mississippi, United States, 39202
        • Jackson Oncology Associates, PLLC
      • Jackson, Mississippi, United States, 39216
        • University of Mississippi School of Medicine
    • Missouri
      • Saint Louis, Missouri, United States, 63136
        • County Oncologist, Inc.
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Cooper Hospital University Medical Center
      • East Brunswick, New Jersey, United States, 08816
        • Regional Cancer Care Associates, LLC
    • New York
      • Fishkill, New York, United States, 12524
        • Hudson Valley Cancer Center
      • Syracuse, New York, United States, 13210
        • SUNY Upstate Medical University
    • North Carolina
      • Greenville, North Carolina, United States, 27834
        • East Carolina School of Medicine
    • Ohio
      • Canton, Ohio, United States, 44710
        • Aultman Medical Group Hematology & Oncology
      • Cincinnati, Ohio, United States, 45219
        • University of Cincinnati Cancer Institute
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
      • Columbus, Ohio, United States, 43210
        • The James Cancer Hospital
    • Pennsylvania
      • Greenville, Pennsylvania, United States, 16125
        • UPMC Hillman Cancer Center
      • Hermitage, Pennsylvania, United States, 16148
        • Steward Sharon Regional Cancer Center
      • New Castle, Pennsylvania, United States, 16105
        • UPMC Hillman Cancer Center
      • Philadelphia, Pennsylvania, United States, 19106
        • Abramson Cancer Center at Pennsylvania Hospital
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • The West Clinic
      • Hixson, Tennessee, United States, 37343
        • Tennessee Oncology PLLC
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • UVAHS Emily Couric Clin Cancer Ctr
    • Washington
      • Olympia, Washington, United States, 98506
        • Kaiser Permanente of WA
      • Poulsbo, Washington, United States, 98370
        • Harrison HealthPartners Hematology
      • Renton, Washington, United States, 98360
        • Seattle Integrative Cancer Center
    • West Virginia
      • Morgantown, West Virginia, United States, 26505
        • Mon Health Medical Center
    • Wisconsin
      • Madison, Wisconsin, United States, 53717
        • SSM Health Cancer Care Center
      • West Allis, Wisconsin, United States, 53227
        • West Allis Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Description

Inclusion Criteria:

  • Are currently receiving olaratumab and who, in consultation with their treating physician, want to continue their course of therapy.
  • Have metastatic or locally advanced unresectable soft tissue sarcoma not amenable to curative treatment with surgery or radiotherapy.
  • Have given written informed consent.
  • Have an absolute neutrophil count (ANC) ≥1,000/microliter.
  • Females of childbearing potential and males must agree to use highly effective contraceptive precautions during treatment with olaratumab and up to 3 months following the last dose of olaratumab. A highly effective method of birth control is defined as one that results in a low failure rate (that is, <1% per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some intrauterine contraceptive devices (IUDs), sexual abstinence, or a vasectomized partner.

Exclusion Criteria:

  • Breastfeeding (patients who discontinue breastfeeding would be considered eligible).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

June 20, 2019

First Submitted That Met QC Criteria

June 20, 2019

First Posted (Actual)

June 21, 2019

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 11, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17468
  • I5B-MC-Y001 (Other Identifier: Eli Lilly and Company)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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