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Olaratumab (LY3012207) Patient Access for Soft Tissue Sarcoma

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ClinicalTrials.gov Identifier: NCT03994627
Expanded Access Status : Available
First Posted : June 21, 2019
Last Update Posted : October 18, 2019
Sponsor:
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

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

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 ClinicalTrials.gov identifier (NCT number): NCT03994627


Contacts
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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 clinicaltrials.gov@lilly.com

  Show 30 Study Locations
Sponsors and Collaborators
Eli Lilly and Company

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03994627     History of Changes
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: October 18, 2019
Last Verified: October 2019
Additional relevant MeSH terms:
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Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Olaratumab
Antineoplastic Agents