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Clinical Trial Details — Status: Available

Administrative data

NCT number NCT03994627
Other study ID # 17468
Secondary ID I5B-MC-Y001
Status Available
Phase
First received
Last updated

Study information

Verified date September 15, 2023
Source Eli Lilly and Company
Contact There may be multiple sites in this clinical trial. 1-877-CTLILL
Phone 1-317-615-4559
Email clinicaltrials.gov@lilly.com
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial Summary

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).


Recruitment information / eligibility

Status Available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Olaratumab
Administered intravenously (IV)

Locations

Country Name City State
Austria Kepler Universitätsklinikum GmbH, Med Campus III Linz Oberösterreich
Austria Ordensklinikum Linz GmbH Elisabethinen Linz Oberösterreich
Brazil Instituto Londrina de Radioterapia Londrina Paraná
Brazil CLION - Clínica de Oncologia Salvador Bahia
Canada CHUM Montreal Quebec
Canada Allan Blair Cancer Centre Regina Saskatchewan
Canada Allan Blair Cancer Centre Regina Saskatchewan
Hungary National Institute of Oncology Budapest
Hungary Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház, Jósa András Oktatókórház Nyiregyhaza Szabolcs-Szatmár-Bereg
India Healthcare Global Enterprises Limited (HCG) Bangalore Karnataka
Italy IRCCS - AOU di Bologna Bologna
Italy Istituto Oncologico Veneto IRCCS Padova Veneto
Italy Ospedale Santa Chiara di Trento Trento
Korea, Republic of Pusan National University Hospital Busan Pusan-Kwangyokshi
Korea, Republic of Wonkwang University Hospital Iksan-si, Jeonlabuk-do
Korea, Republic of Inha University Hospital Incheon Incheon-gwangyeoksi [Incheon]
Korea, Republic of Gachon University Gil Medical Center Namdong-gu Incheon
Korea, Republic of Seoul National University Bundang Hospital Seongnam Kyonggi-do
Spain Hospital Universitari Vall d'Hebron Barcelona
Spain Clínica Mompia Cantabria Santa Cruz De Bezana
Spain Centro Oncológico MD Anderson Madrid
Spain Cl. Universitaria Navarra Madrid
Spain Hospital Clinico San Carlos Madrid
Spain Hospital Madrid Norte Sanchinarro Madrid
Spain Hospital De Navarra Pamplona Navarra
Spain Gerencia de Asistencia Sanitaria de Segovia_Hospital General de Segovia Segovia
Spain Hospital Universitario Virgen Del Rocio Sevilla
Spain Hospital Universitario Virgen Del Rocio Sevilla
Spain Hospital Universitario de Canarias Tenerife La Laguna
Spain Fundación Instituto Valenciano de Oncología Valencia
Spain Hospital Universitario La Fe de Valencia Valencia
Taiwan China Medical University Hospital Taichung
United Kingdom Queen Elizabeth Hospital Birmingham Birmingham
United Kingdom Cambridge University Hospitals NHS Foundation Trust Cambridge
United Kingdom Ninewells Hospital Dundee Scotland
United Kingdom The Christie NHS Foundation Trust Manchester Greater Manchester
United States Northside Hospital Athens Georgia
United States University of Colorado Health Hospital Aurora Colorado
United States SKCCC at Johns Hopkins Baltimore Maryland
United States University of Maryland, Baltimore Baltimore Maryland
United States Hematology Oncology Clinic Baton Rouge Louisiana
United States Cooper Hospital University Medical Center Camden New Jersey
United States Aultman Medical Group Hematology & Oncology Canton Ohio
United States UVAHS Emily Couric Clin Cancer Ctr Charlottesville Virginia
United States Rush University Medical Center Chicago Illinois
United States University of Cincinnati Cancer Institute Cincinnati Ohio
United States Cleveland Clinic Foundation Cleveland Ohio
United States Henry Ford Macomb Hospital Clinton Township Michigan
United States Beacon Cancer Care Coeur d'Alene Idaho
United States The James Cancer Hospital Columbus Ohio
United States St. Luke's Hospital of Duluth Duluth Minnesota
United States Regional Cancer Care Associates, LLC East Brunswick New Jersey
United States Hudson Valley Cancer Center Fishkill New York
United States UCHealth Cancer Center Fort Collins Colorado
United States The West Clinic Germantown Tennessee
United States Baltimore Washington Health Services Glen Burnie Maryland
United States Ironwood Cancer & Research Centers Glendale Arizona
United States Cancer & Hematology Centers of Western Michigan Grand Rapids Michigan
United States Marin Specialty Care, Inc Greenbrae California
United States East Carolina School of Medicine Greenville North Carolina
United States UPMC Hillman Cancer Center Greenville Pennsylvania
United States Steward Sharon Regional Cancer Center Hermitage Pennsylvania
United States Tennessee Oncology PLLC Hixson Tennessee
United States Jackson Oncology Associates, PLLC Jackson Mississippi
United States University of Mississippi School of Medicine Jackson Mississippi
United States Baptist MD Anderson Cancer Center Jacksonville Florida
United States Mayo Clinic in Florida Jacksonville Florida
United States Kaiser Permanente Los Angeles Medical Center Los Angeles California
United States Kaiser Permanente West Los Angeles Los Angeles California
United States The Angeles Clinic & Research Institute Los Angeles California
United States SSM Health Cancer Care Center Madison Wisconsin
United States Masonic Cancer Center, University Minneapolis Minnesota
United States Kaiser Permanente Moreno Valley Moreno Valley California
United States Mon Health Medical Center Morgantown West Virginia
United States UPMC Hillman Cancer Center New Castle Pennsylvania
United States Alton Ochsner Medical Center New Orleans Louisiana
United States Ocala Oncology, P.A. Ocala Florida
United States Kaiser Permanente of WA Olympia Washington
United States Florida Cancer Specialists Orlando Florida
United States Orlando Health UF Health Cancer Center Orlando Florida
United States Illinois Cancer Care Peoria Illinois
United States Abramson Cancer Center at Pennsylvania Hospital Philadelphia Pennsylvania
United States Harrison HealthPartners Hematology Poulsbo Washington
United States Seattle Integrative Cancer Center Renton Washington
United States County Oncologist, Inc. Saint Louis Missouri
United States Florida Cancer Specialists Sarasota Florida
United States SUNY Upstate Medical University Syracuse New York
United States SUNY Upstate Medical University Syracuse New York
United States Oncology-Hematology Associates of West Broward Tamarac Florida
United States Tift Regional Health System Anita Stewart Oncology Center Tifton Georgia
United States West Allis Memorial Hospital West Allis Wisconsin
United States University of Massachusetts Medical Center Worcester Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Austria,  Brazil,  Canada,  Hungary,  India,  Italy,  Korea, Republic of,  Spain,  Taiwan,  United Kingdom, 

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