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Clinical Trials/NCT03994627
NCT03994627
Approved For Marketing
Not Applicable

An Open-Label, Multi-Center Patient Access Program of Olaratumab for the Treatment of Soft Tissue Sarcoma

Eli Lilly and Company87 sites in 1 countryJune 21, 2019
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ConditionsSoft Tissue Sarcoma
DrugsOlaratumab

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Soft Tissue Sarcoma
Sponsor
Eli Lilly and Company
Locations
87
Status
Approved For Marketing
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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).

Registry
clinicaltrials.gov
Start Date
June 21, 2019
End Date
TBD
Last Updated
last year
Study Type
Expanded Access
Sex
All

Investigators

Responsible Party
Sponsor

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).

Outcomes

Primary Outcomes

Not specified

Study Sites (87)

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