Olaratumab (LY3012207) Patient Access for Soft Tissue Sarcoma

NCT ID: NCT03994627

Last Updated: 2024-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

APPROVED_FOR_MARKETING

Study Classification

EXPANDED_ACCESS

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Soft Tissue Sarcoma

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Olaratumab

Administered intravenously (IV)

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

LY3012207

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ironwood Cancer & Research Centers

Glendale, Arizona, United States

Site Status

Marin Specialty Care, Inc

Greenbrae, California, United States

Site Status

The Angeles Clinic & Research Institute

Los Angeles, California, United States

Site Status

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, United States

Site Status

Kaiser Permanente West Los Angeles

Los Angeles, California, United States

Site Status

Kaiser Permanente Moreno Valley

Moreno Valley, California, United States

Site Status

University of Colorado Health Hospital

Aurora, Colorado, United States

Site Status

UCHealth Cancer Center

Fort Collins, Colorado, United States

Site Status

Baptist MD Anderson Cancer Center

Jacksonville, Florida, United States

Site Status

Mayo Clinic in Florida

Jacksonville, Florida, United States

Site Status

Ocala Oncology, P.A.

Ocala, Florida, United States

Site Status

Florida Cancer Specialists

Orlando, Florida, United States

Site Status

Orlando Health UF Health Cancer Center

Orlando, Florida, United States

Site Status

Florida Cancer Specialists

Sarasota, Florida, United States

Site Status

Oncology-Hematology Associates of West Broward

Tamarac, Florida, United States

Site Status

Northside Hospital

Athens, Georgia, United States

Site Status

Tift Regional Health System Anita Stewart Oncology Center

Tifton, Georgia, United States

Site Status

Beacon Cancer Care

Coeur d'Alene, Idaho, United States

Site Status

Rush University Medical Center

Chicago, Illinois, United States

Site Status

Illinois Cancer Care

Peoria, Illinois, United States

Site Status

Hematology Oncology Clinic

Baton Rouge, Louisiana, United States

Site Status

Alton Ochsner Medical Center

New Orleans, Louisiana, United States

Site Status

University of Maryland, Baltimore

Baltimore, Maryland, United States

Site Status

SKCCC at Johns Hopkins

Baltimore, Maryland, United States

Site Status

Baltimore Washington Health Services

Glen Burnie, Maryland, United States

Site Status

University of Massachusetts Medical Center

Worcester, Massachusetts, United States

Site Status

Henry Ford Macomb Hospital

Clinton Township, Michigan, United States

Site Status

Cancer & Hematology Centers of Western Michigan

Grand Rapids, Michigan, United States

Site Status

St. Luke's Hospital of Duluth

Duluth, Minnesota, United States

Site Status

Masonic Cancer Center, University

Minneapolis, Minnesota, United States

Site Status

Jackson Oncology Associates, PLLC

Jackson, Mississippi, United States

Site Status

University of Mississippi School of Medicine

Jackson, Mississippi, United States

Site Status

County Oncologist, Inc.

St Louis, Missouri, United States

Site Status

Cooper Hospital University Medical Center

Camden, New Jersey, United States

Site Status

Regional Cancer Care Associates, LLC

East Brunswick, New Jersey, United States

Site Status

Hudson Valley Cancer Center

Fishkill, New York, United States

Site Status

SUNY Upstate Medical University

Syracuse, New York, United States

Site Status

East Carolina School of Medicine

Greenville, North Carolina, United States

Site Status

Aultman Medical Group Hematology & Oncology

Canton, Ohio, United States

Site Status

University of Cincinnati Cancer Institute

Cincinnati, Ohio, United States

Site Status

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

The James Cancer Hospital

Columbus, Ohio, United States

Site Status

UPMC Hillman Cancer Center

Greenville, Pennsylvania, United States

Site Status

Steward Sharon Regional Cancer Center

Hermitage, Pennsylvania, United States

Site Status

UPMC Hillman Cancer Center

New Castle, Pennsylvania, United States

Site Status

Abramson Cancer Center at Pennsylvania Hospital

Philadelphia, Pennsylvania, United States

Site Status

The West Clinic

Germantown, Tennessee, United States

Site Status

Tennessee Oncology PLLC

Hixson, Tennessee, United States

Site Status

UVAHS Emily Couric Clin Cancer Ctr

Charlottesville, Virginia, United States

Site Status

Kaiser Permanente of WA

Olympia, Washington, United States

Site Status

Harrison HealthPartners Hematology

Poulsbo, Washington, United States

Site Status

Seattle Integrative Cancer Center

Renton, Washington, United States

Site Status

Mon Health Medical Center

Morgantown, West Virginia, United States

Site Status

SSM Health Cancer Care Center

Madison, Wisconsin, United States

Site Status

West Allis Memorial Hospital

West Allis, Wisconsin, United States

Site Status

Ordensklinikum Linz GmbH Elisabethinen

Linz, Upper Austria, Austria

Site Status

Kepler Universitätsklinikum GmbH, Med Campus III

Linz, Upper Austria, Austria

Site Status

CLION - Clínica de Oncologia

Salvador, Estado de Bahia, Brazil

Site Status

Instituto Londrina de Radioterapia

Londrina, Paraná, Brazil

Site Status

CHUM

Montreal, Quebec, Canada

Site Status

Allan Blair Cancer Centre

Regina, Saskatchewan, Canada

Site Status

Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház, Jósa András Oktatókórház

Nyíregyháza, Szabolcs-Szatmár-Bereg, Hungary

Site Status

National Institute of Oncology

Budapest, , Hungary

Site Status

Healthcare Global Enterprises Limited (HCG)

Bangalore, Karnataka, India

Site Status

Istituto Oncologico Veneto IRCCS

Padua, Veneto, Italy

Site Status

IRCCS - AOU di Bologna

Bologna, , Italy

Site Status

Ospedale Santa Chiara di Trento

Trento, , Italy

Site Status

Gachon University Gil Medical Center

Namdong-gu, Incheon, South Korea

Site Status

Inha University Hospital

Incheon, Incheon-gwangyeoksi [Incheon], South Korea

Site Status

Seoul National University Bundang Hospital

Seongnam, Kyǒnggi-do, South Korea

Site Status

Pusan National University Hospital

Busan, Pusan-Kwangyǒkshi, South Korea

Site Status

Wonkwang University Hospital

Iksan-si, Jeonlabuk-do, , South Korea

Site Status

Hospital Universitario de Canarias

Santa Cruz de Tenerife, La Laguna, Spain

Site Status

Hospital De Navarra

Pamplona, Navarre, Spain

Site Status

Clínica Mompia

Cantabria, Santa Cruz de Bezana, Spain

Site Status

Hospital Universitari Vall d'Hebron

Barcelona, , Spain

Site Status

Cl. Universitaria Navarra

Madrid, , Spain

Site Status

Centro Oncológico MD Anderson

Madrid, , Spain

Site Status

Hospital Clinico San Carlos

Madrid, , Spain

Site Status

Hospital Madrid Norte Sanchinarro

Madrid, , Spain

Site Status

Gerencia de Asistencia Sanitaria de Segovia_Hospital General de Segovia

Segovia, , Spain

Site Status

Hospital Universitario Virgen Del Rocio

Seville, , Spain

Site Status

Fundación Instituto Valenciano de Oncología

Valencia, , Spain

Site Status

Hospital Universitario La Fe de Valencia

Valencia, , Spain

Site Status

China Medical University Hospital

Taichung, , Taiwan

Site Status

The Christie NHS Foundation Trust

Manchester, Greater Manchester, United Kingdom

Site Status

Ninewells Hospital

Dundee, Scotland, United Kingdom

Site Status

Queen Elizabeth Hospital Birmingham

Birmingham, , United Kingdom

Site Status

Cambridge University Hospitals NHS Foundation Trust

Cambridge, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Cyprus United States Austria Brazil Canada Hungary India Italy South Korea Spain Taiwan United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

I5B-MC-Y001

Identifier Type: OTHER

Identifier Source: secondary_id

17468

Identifier Type: -

Identifier Source: org_study_id