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出境医 / 临床实验 / Olaratumab (LY3012207) Patient Access for Soft Tissue Sarcoma

Olaratumab (LY3012207) Patient Access for Soft Tissue Sarcoma

Study Description
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

Study Design
Layout table for study information
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
Arms and Interventions
Outcome Measures
Eligibility Criteria
Contacts and Locations
Tracking Information
First Submitted Date June 20, 2019
First Posted Date June 21, 2019
Last Update Posted Date June 8, 2021
 
Descriptive Information
Brief Title Olaratumab (LY3012207) Patient Access for Soft Tissue Sarcoma
Official Title An Open-Label, Multi-Center Patient Access Program of Olaratumab for the Treatment of Soft Tissue Sarcoma
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).
Detailed Description Not Provided
Study Type Expanded Access
Expanded Access Type Individual Patients
Condition Soft Tissue Sarcoma
Intervention Drug: Olaratumab
Administered intravenously (IV)
Other Name: LY3012207
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Expanded Access Status Available
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).
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Contacts
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
Listed Location Countries Austria,   Brazil,   Canada,   Hungary,   India,   Italy,   Korea, Republic of,   Spain,   Taiwan,   United Kingdom,   United States
Removed Location Countries Cyprus
 
Administrative Information
NCT Number NCT03994627
Other Study ID Numbers 17468
I5B-MC-Y001 ( Other Identifier: Eli Lilly and Company )
Responsible Party Eli Lilly and Company
Study Sponsor Eli Lilly and Company
Collaborators Not Provided
Investigators Not Provided
PRS Account Eli Lilly and Company
Verification Date June 1, 2021

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