Soft Tissue SarcomaNCT03994627
Olaratumab (LY3012207) Patient Access for Soft Tissue Sarcoma
A study testing Olaratumab in people with Soft Tissue Sarcoma, run by Eli Lilly and Company at 89 sites in 11 countries.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Soft Tissue Sarcoma
- What is being tested?
- Olaratumab
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- 89 sitesin 11 countries
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Breastfeeding (patients who discontinue breastfeeding would be considered eligible).
Trial locations and contacts
89 sites in 11 countries.
89 sites in 11 countries
United States55 sites
Northside Hospital
Athens, Georgia, 30606
University of Colorado Health Hospital
Aurora, Colorado, 80045
University of Maryland, Baltimore
Baltimore, Maryland, 21201
SKCCC at Johns Hopkins
Baltimore, Maryland, 21287
Hematology Oncology Clinic
Baton Rouge, Louisiana, 70809
Cooper Hospital University Medical Center
Camden, New Jersey, 08103
Aultman Medical Group Hematology & Oncology
Canton, Ohio, 44710
UVAHS Emily Couric Clin Cancer Ctr
Charlottesville, Virginia, 22903
Rush University Medical Center
Chicago, Illinois, 60612
University of Cincinnati Cancer Institute
Cincinnati, Ohio, 45219
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Henry Ford Macomb Hospital
Clinton Township, Michigan, 48038
Beacon Cancer Care
Coeur d'Alene, Idaho, 83814
The James Cancer Hospital
Columbus, Ohio, 43210
St. Luke's Hospital of Duluth
Duluth, Minnesota, 55805
Regional Cancer Care Associates, LLC
East Brunswick, New Jersey, 08816
Hudson Valley Cancer Center
Fishkill, New York, 12524
UCHealth Cancer Center
Fort Collins, Colorado, 80528
The West Clinic
Germantown, Tennessee, 38138
Baltimore Washington Health Services
Glen Burnie, Maryland, 21061
Ironwood Cancer & Research Centers
Glendale, Arizona, 85306
Cancer & Hematology Centers of Western Michigan
Grand Rapids, Michigan, 49503
Marin Specialty Care, Inc
Greenbrae, California, 94904
East Carolina School of Medicine
Greenville, North Carolina, 27834
UPMC Hillman Cancer Center
Greenville, Pennsylvania, 16125
Steward Sharon Regional Cancer Center
Hermitage, Pennsylvania, 16148
Tennessee Oncology PLLC
Hixson, Tennessee, 37343
Jackson Oncology Associates, PLLC
Jackson, Mississippi, 39202
University of Mississippi School of Medicine
Jackson, Mississippi, 39216
Baptist MD Anderson Cancer Center
Jacksonville, Florida, 32207
Mayo Clinic in Florida
Jacksonville, Florida, 32224
The Angeles Clinic & Research Institute
Los Angeles, California, 90025
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027
Kaiser Permanente West Los Angeles
Los Angeles, California, 90034
SSM Health Cancer Care Center
Madison, Wisconsin, 53717
Masonic Cancer Center, University
Minneapolis, Minnesota, 55455
Kaiser Permanente Moreno Valley
Moreno Valley, California, 92555
Mon Health Medical Center
Morgantown, West Virginia, 26505
UPMC Hillman Cancer Center
New Castle, Pennsylvania, 16105
Alton Ochsner Medical Center
New Orleans, Louisiana, 70121
Ocala Oncology, P.A.
Ocala, Florida, 34474
Kaiser Permanente of WA
Olympia, Washington, 98506
Florida Cancer Specialists
Orlando, Florida, 32804
Orlando Health UF Health Cancer Center
Orlando, Florida, 32806
Illinois Cancer Care
Peoria, Illinois, 61615
Abramson Cancer Center at Pennsylvania Hospital
Philadelphia, Pennsylvania, 19106
Harrison HealthPartners Hematology
Poulsbo, Washington, 98370
Seattle Integrative Cancer Center
Renton, Washington, 98360
Florida Cancer Specialists
Sarasota, Florida, 34236
County Oncologist, Inc.
St Louis, Missouri, 63136
SUNY Upstate Medical University
Syracuse, New York, 13210
Oncology-Hematology Associates of West Broward
Tamarac, Florida, 33321
Tift Regional Health System Anita Stewart Oncology Center
Tifton, Georgia, 31794
West Allis Memorial Hospital
West Allis, Wisconsin, 53227
University of Massachusetts Medical Center
Worcester, Massachusetts, 01655
Spain12 sites
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Clínica Mompia
Cantabria, Santa Cruz de Bezana, 39109
Cl. Universitaria Navarra
Madrid, 28022
Centro Oncológico MD Anderson
Madrid, 28033
Hospital Clinico San Carlos
Madrid, 28040
Hospital Madrid Norte Sanchinarro
Madrid, 28050
Hospital De Navarra
Pamplona, Navarre, 31008
Hospital Universitario de Canarias
Santa Cruz de Tenerife, La Laguna, 38320
Gerencia de Asistencia Sanitaria de Segovia_Hospital General de Segovia
Segovia, 40002
Hospital Universitario Virgen Del Rocio
Seville, 41013
Fundación Instituto Valenciano de Oncología
Valencia, 46009
Hospital Universitario La Fe de Valencia
Valencia, 46026
South Korea5 sites
Pusan National University Hospital
Busan, Pusan-Kwangyǒkshi, 49241
Wonkwang University Hospital
Iksan-si, Jeonlabuk-do, 54538
Inha University Hospital
Incheon, Incheon-gwangyeoksi [Incheon], 22332
Gachon University Gil Medical Center
Namdong-gu, Incheon, 21565
Seoul National University Bundang Hospital
Seongnam, Kyǒnggi-do, 13620
United Kingdom4 sites
Queen Elizabeth Hospital Birmingham
Birmingham, B15 2WB
Cambridge University Hospitals NHS Foundation Trust
Cambridge, CB2 0QQ
Ninewells Hospital
Dundee, Scotland, DD1 9SY
The Christie NHS Foundation Trust
Manchester, Greater Manchester, M20 4BX
Italy3 sites
IRCCS - AOU di Bologna
Bologna, 40138
Istituto Oncologico Veneto IRCCS
Padova, Veneto, 35128
Ospedale Santa Chiara di Trento
Trento, 38122
Austria2 sites
Ordensklinikum Linz GmbH Elisabethinen
Linz, Upper Austria, 4020
Kepler Universitätsklinikum GmbH, Med Campus III
Linz, Upper Austria, 4021
Brazil2 sites
Instituto Londrina de Radioterapia
Londrina, Paraná, 86050-435
CLION - Clínica de Oncologia
Salvador, Estado de Bahia, 40170-010
Canada2 sites
CHUM
Montreal, Quebec, H2V 2E2
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1
Hungary2 sites
National Institute of Oncology
Budapest, 1122
Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház, Jósa András Oktatókórház
Nyíregyháza, Szabolcs-Szatmár-Bereg, 4400
India1 site
Healthcare Global Enterprises Limited (HCG)
Bangalore, Karnataka, 560027
About this study
Official title: 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).
- Conditions
- Soft Tissue Sarcoma
- Being tested
- Olaratumab
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlaratumabDrug
Also called LY3012207
Administered intravenously (IV)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue SarcomaStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03994627
- Sponsor's protocol ID
- 17468
- Other IDs
- I5B-MC-Y001
- Status last verified
- Dec 2024
- First submitted
- 20 Jun 2019
- Last updated
- 16 Dec 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multi-Center Patient Access Program of Olaratumab for the Treatment of Soft Tissue Sarcoma
- ClinicalTrials.gov ID
- NCT03994627
- Acronym / sponsor ID
- 17468
- Conditions
- Soft Tissue Sarcoma
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- First posted
- 21 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- Breastfeeding (patients who discontinue breastfeeding would be considered eligible).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OlaratumabAlso: LY3012207Administered intravenously (IV) | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
89 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Olaratumab in people with Soft Tissue Sarcoma, run by Eli Lilly and Company at 89 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 89 sites in United States, Spain, South Korea, United Kingdom, Italy and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2024.