Olaratumab (LY3012207) Patient Access for Soft Tissue Sarcoma

Lilly

Status

Conditions: Soft Tissue Sarcoma

Treatments: Drug: Olaratumab

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT03994627

I5B-MC-Y001 (Other Identifier)

17468

Details and patient eligibility

About

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).

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).