Eli Lilly and Company

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
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).
Available
EA Type
Individual Patients
Soft Tissue Sarcoma

Drug: Olaratumab
Administered intravenously (IV)
Other Name: LY3012207

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).

Eligibility Gender: 
All
Eligibility Age: 
Minimum: 18 Years
Countries: 
United States
Locations: 

Alton Ochsner Medical Center
New Orleans, Louisiana, 70121

Contact: 504-376-3863

Investigator: Marc R Matrana

Steward Sharon Regional Cancer Center
Hermitage, Pennsylvania, 16148

Contact: 724-983-5900

Investigator: Mukhtar O Hassan

The West Clinic
Germantown, Tennessee, 38138

Contact: 901-683-0055

Investigator: David C Portnoy

Mon Health Medical Center
Morgantown, West Virginia, 26505

Contact: 304-285-3870

Investigator: William C McBee

West Allis Memorial Hospital
West Allis, Wisconsin, 93227

Investigator: Elizabeth Dickson

Contacts: 

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
clinicaltrials.gov@lilly.com

Eli Lilly and Company
EA Number: 
MeSH Terms: 
Sarcoma, Olaratumab
Disclaimer:
Expanded Access program information for companies listed in the Expanded Access Company Directory is pulled daily from ClinicalTrials.gov, a resource provided by the National Institutes of Health in cooperation with the U.S. Food and Drug Administration. Click here for more information about ClinicalTrials.gov.