Olaratumab (LY3012207) Patient Access for Soft Tissue Sarcoma

Sponsor: Eli Lilly and Company

Expanded Access
Approved for Marketing
Sponsor score: 60
Inactive

ClinicalTrials ID:NCT03994627

Patient View

This study provides continued access to olaratumab for patients with metastatic or locally advanced unresectable soft tissue sarcoma. Eligible participants must currently be on olaratumab, have adequate neutrophil counts, and agree to contraceptive use. Olaratumab is administered intravenously. Breastfeeding patients are excluded unless they discontinue breastfeeding.

Patient Parameters

Program Overview

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).

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).

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