Olaratumab (LY3012207) Patient Access for Soft Tissue Sarcoma

September 28, 2023 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

Available

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 Contact

  • Name: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 1-317-615-4559
  • Email: ClinicalTrials.gov@lilly.com

Study Locations

  • Austria
    • Oberösterreich
      • Linz, Oberösterreich, Austria, 4020
        • Available
        • Ordensklinikum Linz Gmbh Elisabethinen
        • Contact:
          • Phone Number: 43073276760
        • Principal Investigator:
          • Veronika Buxhofer-Ausch
      • Linz, Oberösterreich, Austria, 4021
        • Available
        • Kepler Universitätsklinikum GmbH, Med Campus III
        • Contact:
          • Phone Number: 43057680830
        • Principal Investigator:
          • Daniela Voskova
  • Brazil
    • Bahia
      • Salvador, Bahia, Brazil, 40170-010
        • Available
        • CLION - Clínica de Oncologia
        • Contact:
          • Phone Number: +55 71 2105-6565
        • Principal Investigator:
          • Isadora Badaro Cedraz Oliveira
    • Paraná
      • Londrina, Paraná, Brazil, 86050-435
        • Available
        • Instituto Londrina de Radioterapia
        • Contact:
          • Phone Number: +55 43 3372-2550
        • Principal Investigator:
          • Bruno Scardazzi Pozzi
  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H2V 2E2
        • Available
        • CHUM
        • Contact:
          • Phone Number: 514-890-8000 x30921
        • Principal Investigator:
          • Cormier Beatrice
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4T 7T1
        • Available
        • Allan Blair Cancer Centre
        • Contact:
          • Phone Number: 3067662691
        • Principal Investigator:
          • Muhammad Khan
  • Hungary
      • Budapest, Hungary, 1122
        • Available
        • National Institute of Oncology
        • Contact:
          • Phone Number: (+36-1) 224-8600 / 3415
        • Principal Investigator:
          • Erika Hitre
    • Szabolcs-Szatmár-Bereg
      • Nyiregyhaza, Szabolcs-Szatmár-Bereg, Hungary, 4400
        • Available
        • Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház, Jósa András Oktatókórház
        • Contact:
          • Phone Number: 3642465666
        • Principal Investigator:
          • Judit Vass
  • India
    • Karnataka
      • Bangalore, Karnataka, India, 560027
        • Available
        • Healthcare Global Enterprises Limited (HCG)
        • Contact:
          • Phone Number: 919242698750
        • Principal Investigator:
          • Shobha Aravind
  • Italy
      • Bologna, Italy, 40138
        • Available
        • IRCCS - AOU di Bologna
        • Contact:
          • Phone Number: +390512142206
        • Principal Investigator:
          • Maria Pantaleo
      • Trento, Italy, 38122
        • Available
        • Ospedale Santa Chiara di Trento
        • Contact:
          • Phone Number: 390461903178
        • Principal Investigator:
          • Carlo Messina
    • Veneto
      • Padova, Veneto, Italy, 35128
        • Available
        • Istituto Oncologico Veneto IRCCS
        • Contact:
          • Phone Number: 390498215953
        • Principal Investigator:
          • Antonella Brunello
  • Korea, Republic of
      • Iksan-si, Jeonlabuk-do, Korea, Republic of, 54538
        • Available
        • Wonkwang University Hospital
        • Contact:
          • Phone Number: +82-63-859-1181
        • Principal Investigator:
          • Seung-Shin Lee
    • Incheon
      • Namdong-gu, Incheon, Korea, Republic of, 21565
        • Available
        • Gachon University Gil Medical Center
        • Contact:
          • Phone Number: +82-32-460-3227
        • Principal Investigator:
          • Young Saing Kim
    • Incheon-gwangyeoksi [Incheon]
      • Incheon, Incheon-gwangyeoksi [Incheon], Korea, Republic of, 22332
        • Available
        • Inha University Hospital
        • Contact:
          • Phone Number: +82-32-890-2580
        • Principal Investigator:
          • Joo Han Lim
    • Kyǒnggi-do
      • Seongnam, Kyǒnggi-do, Korea, Republic of, 13620
        • Available
        • Seoul National University Bundang Hospital
        • Contact:
          • Phone Number: +82-31-787-7053
        • Principal Investigator:
          • Jin Won Kim
    • Pusan-Kwangyǒkshi
      • Busan, Pusan-Kwangyǒkshi, Korea, Republic of, 49241
        • Available
        • Pusan National University Hospital
        • Contact:
          • Phone Number: +82-10-6252-8197
        • Principal Investigator:
          • Hyojeong Kim
  • Spain
      • Barcelona, Spain, 08035
        • Available
        • Hospital Universitari Vall d'Hebron
        • Principal Investigator:
          • Claudia Maria Valverde Morales
      • Madrid, Spain, 28022
        • Available
        • Cl. Universitaria Navarra
        • Principal Investigator:
          • Luisa Sánchez Lorenzo
      • Madrid, Spain, 28033
        • Available
        • Centro Oncológico MD Anderson
        • Contact:
          • Phone Number: 913834980
        • Principal Investigator:
          • Ricardo Cubedo
      • Madrid, Spain, 28050
        • Available
        • Hospital Madrid Norte Sanchinarro
        • Contact:
          • Phone Number: 917567800
        • Principal Investigator:
          • Antonio Cubillo Gracián
      • Madrid, Spain, 28040
        • Available
        • Hospital Clinico San Carlos
        • Contact:
          • Phone Number: 34913303000
        • Principal Investigator:
          • Gloria Marquina
      • Segovia, Spain, 40002
        • Available
        • Gerencia de Asistencia Sanitaria de Segovia_Hospital General de Segovia
        • Contact:
          • Phone Number: 34 921 41 91 00
        • Principal Investigator:
          • María Cornide
      • Sevilla, Spain, 41013
        • Available
        • Hospital Universitario Virgen Del Rocio
        • Principal Investigator:
          • Irene Carrasco Garcia
      • Valencia, Spain, 46009
        • Available
        • Fundación Instituto Valenciano de Oncología
        • Contact:
          • Phone Number: 34 961 114 000
        • Principal Investigator:
          • Javier Lavernia Giner
      • Valencia, Spain, 46026
        • Available
        • Hospital Universitario La Fe de Valencia
        • Contact:
          • Phone Number: 34963862700
        • Principal Investigator:
          • Roberto Diaz Beveridge
    • La Laguna
      • Tenerife, La Laguna, Spain, 38320
        • Available
        • Hospital Universitario de Canarias
        • Principal Investigator:
          • Josefina Cruz Jurado
        • Contact:
          • Phone Number: 3499226878989
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Available
        • Hospital de Navarra
        • Contact:
          • Phone Number: 348484222222
        • Principal Investigator:
          • Lucia Teijeira
    • Santa Cruz De Bezana
      • Cantabria, Santa Cruz De Bezana, Spain, 39109
        • Available
        • Clínica Mompia
        • Contact:
          • Phone Number: 34 942 584 100
        • Principal Investigator:
          • Ágata Pérez Ochoa
  • Taiwan
      • Taichung, Taiwan, 40447
        • Available
        • China Medical University Hospital
        • Contact:
          • Phone Number: 886422052121
        • Principal Investigator:
          • Chen Tzu-Ting
  • United Kingdom
      • Birmingham, United Kingdom, B15 2WB
        • Available
        • Queen Elizabeth Hospital Birmingham
        • Principal Investigator:
          • M PEAKE
      • Cambridge, United Kingdom, CB2 0QQ
        • Available
        • Cambridge University Hospitals NHS Foundation Trust
        • Principal Investigator:
          • Han Wong
    • Greater Manchester
      • Manchester, Greater Manchester, United Kingdom, M20 4BX
        • Available
        • The Christie NHS Foundation Trust
        • Principal Investigator:
          • Michael Leahy
    • Scotland
      • Dundee, Scotland, United Kingdom, DD1 9SY
        • Available
        • Ninewells Hospital
        • Contact:
          • Phone Number: 01382660111
        • Principal Investigator:
          • Michelle Ferguson
  • United States
    • Arizona
      • Glendale, Arizona, United States, 85306
        • Available
        • Ironwood Cancer & Research Centers
        • Contact:
          • Phone Number: 480-324-5262
        • Principal Investigator:
          • Elisa Bomgaars
    • California
      • Greenbrae, California, United States, 94904
        • Available
        • Marin Specialty Care, Inc
        • Contact:
          • Phone Number: 415-925-5000
        • Principal Investigator:
          • Barbara Galligan
      • Los Angeles, California, United States, 90025
        • Available
        • The Angeles Clinic & Research Institute
        • Contact:
          • Phone Number: 310-231-2118
        • Principal Investigator:
          • Lawrence Piro
      • Los Angeles, California, United States, 90027
        • Available
        • Kaiser Permanente Los Angeles Medical Center
        • Contact:
          • Phone Number: 323-783-9013
        • Principal Investigator:
          • Karen Kwan
      • Los Angeles, California, United States, 90034
        • Available
        • Kaiser Permanente West Los Angeles
        • Contact:
          • Phone Number: 323-857-2713
        • Principal Investigator:
          • Cannon Milani
      • Moreno Valley, California, United States, 92555
        • Available
        • Kaiser Permanente Moreno Valley
        • Contact:
          • Phone Number: 626-564-3506
        • Principal Investigator:
          • Vishal Ranpura
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Available
        • University of Colorado Health Hospital
        • Contact:
          • Phone Number: 720-848-0300
        • Principal Investigator:
          • Victor Villalobos
      • Fort Collins, Colorado, United States, 80528
        • Available
        • UCHealth Cancer Center
        • Contact:
          • Phone Number: 970-297-6150
        • Principal Investigator:
          • Diana Medgyesy
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Available
        • Baptist MD Anderson Cancer Center
        • Contact:
          • Phone Number: 904-202-7300
        • Principal Investigator:
          • William Hammond
      • Jacksonville, Florida, United States, 32224
        • Available
        • Mayo Clinic in Florida
        • Contact:
          • Phone Number: 904-953-2000
        • Principal Investigator:
          • Steven Attia
      • Ocala, Florida, United States, 34474
        • Available
        • Ocala Oncology, P.A.
        • Principal Investigator:
          • Ketan Doshi
      • Orlando, Florida, United States, 32804
        • Available
        • Florida Cancer Specialists
        • Contact:
          • Phone Number: 407-898-5452
        • Principal Investigator:
          • Yaman Suleiman
      • Orlando, Florida, United States, 32806
        • Available
        • Orlando Health UF Health Cancer Center
        • Principal Investigator:
          • Thomas Sajeve
      • Sarasota, Florida, United States, 34236
        • Available
        • Florida Cancer Specialists
        • Principal Investigator:
          • Caryn Silver
      • Tamarac, Florida, United States, 33321
        • Available
        • Oncology-Hematology Associates of West Broward
        • Principal Investigator:
          • Sumit Sawhney
        • Contact:
          • Phone Number: 954-726-0035
    • Georgia
      • Athens, Georgia, United States, 30606
        • Available
        • Northside Hospital
        • Contact:
          • Phone Number: 7063694478x5936
        • Principal Investigator:
          • Ali Sayed
      • Tifton, Georgia, United States, 31794
        • Available
        • Tift Regional Health System Anita Stewart Oncology Center
        • Contact:
          • Phone Number: 229-382-7120
        • Principal Investigator:
          • James Milner
    • Idaho
      • Coeur d'Alene, Idaho, United States, 83814
        • Available
        • Beacon Cancer Care
        • Contact:
          • Phone Number: 208-755-2804
        • Principal Investigator:
          • David Bartels
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Available
        • Rush University Medical Center
        • Principal Investigator:
          • Marta Batus
        • Contact:
          • Phone Number: 312-226-2371
      • Peoria, Illinois, United States, 61615
        • Available
        • Illinois Cancer Care
        • Contact:
          • Phone Number: 309-243-3000
        • Principal Investigator:
          • Nguyet Le-Lindqwister
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Available
        • Hematology Oncology Clinic
        • Contact:
          • Phone Number: 225-767-0822
        • Principal Investigator:
          • Gerald Miletello
      • New Orleans, Louisiana, United States, 70121
        • Available
        • Alton Ochsner Medical Center
        • Contact:
          • Phone Number: 504-376-3863
        • Principal Investigator:
          • Marc Matrana
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Available
        • University of Maryland, Baltimore
        • Contact:
          • Phone Number: 410-328-2703
        • Principal Investigator:
          • Amin Benyounes
      • Baltimore, Maryland, United States, 21287
        • Available
        • SKCCC at Johns Hopkins
        • Contact:
          • Phone Number: 410-614-1361
        • Principal Investigator:
          • Stephanie Gaillard
      • Glen Burnie, Maryland, United States, 21061
        • Available
        • Baltimore Washington Health Services
        • Contact:
          • Phone Number: 410-553-8360
        • Principal Investigator:
          • Harvinder Singh
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • Available
        • University of Massachusetts Medical Center
        • Contact:
          • Phone Number: 505-856-0056
        • Principal Investigator:
          • William Walsh
    • Michigan
      • Clinton Township, Michigan, United States, 48038
        • Available
        • Henry Ford Macomb Hospital
        • Contact:
          • Phone Number: 586-263-2269
        • Principal Investigator:
          • Malathy Kilaru
      • Grand Rapids, Michigan, United States, 49503
        • Available
        • Cancer & Hematology Centers of Western Michigan
        • Contact:
          • Phone Number: 616-954-9800
        • Principal Investigator:
          • Judy Tsai
    • Minnesota
      • Duluth, Minnesota, United States, 55805
        • Available
        • St. Luke's Hospital of Duluth
        • Principal Investigator:
          • Homam Alkaied
        • Contact:
          • Phone Number: 218-249-2567
      • Minneapolis, Minnesota, United States, 55455
        • Available
        • Masonic Cancer Center, University
        • Principal Investigator:
          • Domingo Musibay Evidio
    • Mississippi
      • Jackson, Mississippi, United States, 39202
        • Available
        • Jackson Oncology Associates, PLLC
        • Contact:
          • Phone Number: 601-355-2485
        • Principal Investigator:
          • Justin Baker
      • Jackson, Mississippi, United States, 39216
        • Available
        • University of Mississippi School of Medicine
        • Principal Investigator:
          • Mildred Ridgway
    • Missouri
      • Saint Louis, Missouri, United States, 63136
        • Available
        • County Oncologist, Inc.
        • Contact:
          • Phone Number: 314-355-8200
        • Principal Investigator:
          • Juan Carden
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Available
        • Cooper Hospital University Medical Center
        • Principal Investigator:
          • Polina Khrizman
        • Contact:
          • Phone Number: 856-735-6289
      • East Brunswick, New Jersey, United States, 08816
        • Available
        • Regional Cancer Care Associates, LLC
        • Contact:
          • Phone Number: 732-390-7750
        • Principal Investigator:
          • MICHAEL NISSENBLATT
    • New York
      • Fishkill, New York, United States, 12524
        • Available
        • Hudson Valley Cancer Center
        • Contact:
          • Phone Number: 845-896-8510
        • Principal Investigator:
          • Julia Schaefer-Cutillo
      • Syracuse, New York, United States, 13210
        • Available
        • SUNY Upstate Medical University
        • Contact:
          • Phone Number: 315-464-8230
        • Principal Investigator:
          • Seth Rahul
    • North Carolina
      • Greenville, North Carolina, United States, 27834
        • Available
        • East Carolina School of Medicine
        • Contact:
          • Phone Number: 252-756-5388
        • Principal Investigator:
          • Darla Liles
    • Ohio
      • Canton, Ohio, United States, 44710
        • Available
        • Aultman Medical Group Hematology & Oncology
        • Principal Investigator:
          • Shruti Trehan
      • Cincinnati, Ohio, United States, 45219
        • Available
        • University of Cincinnati Cancer Institute
        • Principal Investigator:
          • Amanda Jackson
        • Contact:
          • Phone Number: 513-584-6373
      • Cleveland, Ohio, United States, 44195
        • Available
        • Cleveland Clinic Foundation
        • Contact:
          • Phone Number: 216-444-1128
        • Principal Investigator:
          • Dale Shepard
      • Columbus, Ohio, United States, 43210
        • Available
        • The James Cancer Hospital
        • Contact:
          • Phone Number: 614-685-7377
        • Principal Investigator:
          • Gabriel Tinoco
    • Pennsylvania
      • Greenville, Pennsylvania, United States, 16125
        • Available
        • UPMC Hillman Cancer Center
        • Contact:
          • Phone Number: 724-589-4318
        • Principal Investigator:
          • Mukhtar Hassan
      • Hermitage, Pennsylvania, United States, 16148
        • Available
        • Steward Sharon Regional Cancer Center
        • Contact:
          • Phone Number: 724-983-5900
        • Principal Investigator:
          • Mukhtar Hassan
      • New Castle, Pennsylvania, United States, 16105
        • Available
        • UPMC Hillman Cancer Center
        • Contact:
          • Phone Number: 724-658-7300
        • Principal Investigator:
          • Amanda Laubenthal
      • Philadelphia, Pennsylvania, United States, 19106
        • Available
        • Abramson Cancer Center at Pennsylvania Hospital
        • Contact:
          • Phone Number: 215-829-7089
        • Principal Investigator:
          • Lee Hartner
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Available
        • The West Clinic
        • Contact:
          • Phone Number: 901-683-0055
        • Principal Investigator:
          • David Portnoy
      • Hixson, Tennessee, United States, 37343
        • Available
        • Tennessee Oncology PLLC
        • Contact:
          • Phone Number: 423-876-0336
        • Principal Investigator:
          • Michael Stipanov
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • Available
        • UVAHS Emily Couric Clin Cancer Ctr
        • Contact:
          • Phone Number: 434-924-9333
        • Principal Investigator:
          • Leigh Cantrell
    • Washington
      • Olympia, Washington, United States, 98506
        • Available
        • Kaiser Permanente of WA
        • Contact:
          • Phone Number: 360-923-7000
        • Principal Investigator:
          • Rachna Anand
      • Poulsbo, Washington, United States, 98370
        • Available
        • Harrison HealthPartners Hematology
        • Principal Investigator:
          • Toni Roberts
      • Renton, Washington, United States, 98360
        • Available
        • Seattle Integrative Cancer Center
        • Contact:
          • Phone Number: 206-588-1722
        • Principal Investigator:
          • Naixi Chen
    • West Virginia
      • Morgantown, West Virginia, United States, 26505
        • Available
        • Mon Health Medical Center
        • Contact:
          • Phone Number: 304-285-3870
        • Principal Investigator:
          • William McBee
    • Wisconsin
      • Madison, Wisconsin, United States, 53717
        • Available
        • SSM Health Cancer Care Center
        • Contact:
          • Phone Number: 608-410-2700
        • Principal Investigator:
          • Lisa Lepeak
      • West Allis, Wisconsin, United States, 53227
        • Available
        • West Allis Memorial Hospital
        • Principal Investigator:
          • Elizabeth Dickson

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)

September 29, 2023

Last Update Submitted That Met QC Criteria

September 28, 2023

Last Verified

September 15, 2023

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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