Clinical trial NCT03994627: Olaratumab (LY3012207) Patient Access for Soft Tissue Sarcoma
Official title: An Open-Label, Multi-Center Patient Access Program of Olaratumab for the Treatment of Soft Tissue Sarcoma
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Soft Tissue Sarcoma
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2019-06-21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief 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).


Eligibility criteria: 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).

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