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Olaratumab (LY3012207) Patient Access for Soft Tissue Sarcoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03994627
Expanded Access Status : Available
First Posted : June 21, 2019
Last Update Posted : May 18, 2022
Information provided by (Responsible Party):
Eli Lilly and Company

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).

Condition or disease Intervention/treatment
Soft Tissue Sarcoma Drug: Olaratumab

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Study Type : Expanded Access
Expanded Access Type : Individual Patients
Official Title: An Open-Label, Multi-Center Patient Access Program of Olaratumab for the Treatment of Soft Tissue Sarcoma

Intervention Details:
  • Drug: Olaratumab
    Administered intravenously (IV)
    Other Name: LY3012207

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03994627

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Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559

Show Show 93 study locations
Sponsors and Collaborators
Eli Lilly and Company
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Responsible Party: Eli Lilly and Company Identifier: NCT03994627    
Other Study ID Numbers: 17468
I5B-MC-Y001 ( Other Identifier: Eli Lilly and Company )
First Posted: June 21, 2019    Key Record Dates
Last Update Posted: May 18, 2022
Last Verified: May 15, 2022
Additional relevant MeSH terms:
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Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Antineoplastic Agents