Soft Tissue Sarcoma Clinical Trial
Official title:
An Open-Label, Multi-Center Patient Access Program of Olaratumab for the Treatment of Soft Tissue Sarcoma
| NCT number | NCT03994627 |
| Other study ID # | 17468 |
| Secondary ID | I5B-MC-Y001 |
| Status | Available |
| Phase | |
| First received | |
| Last updated |
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).
| 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). |
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Eli Lilly and Company |
United States, Austria, Brazil, Canada, Hungary, India, Italy, Korea, Republic of, Spain, Taiwan, United Kingdom,
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