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

Status

Indicates the current recruitment status or the expanded access status.
Approved for marketing

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Expanded Access

Expanded Access Type

Expanded Access Type

Describes the category of expanded access under U.S. Food and Drug Administration (FDA) regulations. There are three types of expanded access:
  • Individual Patients: Allows a single patient, with a serious disease or condition who cannot participate in a clinical trial, access to a drug or biological product that has not been approved by the FDA. This category also includes access in an emergency situation.
  • Intermediate-size Population: Allows more than one patient (but generally fewer patients than through a Treatment IND/Protocol) access to a drug or biological product that has not been approved by the FDA. This type of expanded access is used when multiple patients with the same disease or condition seek access to a specific drug or biological product that has not been approved by the FDA.
  • Treatment IND/Protocol: Allows a large, widespread population access to a drug or biological product that has not been approved by the FDA. This type of expanded access can only be provided if the product is already being developed for marketing for the same use as the expanded access use.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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
        • 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
        • Fundacion Instituto Valenciano de Oncologia
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 20, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 21, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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