A Study of Olaratumab (LY3012207) in Participants With Advanced Soft Tissue Sarcoma

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Soft Tissue Sarcoma

In brief

The main purpose of this study is to evaluate the safety and efficacy of two anti-cancer drugs (gemcitabine and docetaxel) with and without the study drug known as olaratumab in participants with advanced soft tissue sarcoma (STS) or STS that has spread to another part(s) of the body.

Key facts

Study ID

NCT02659020

Run by

Eli Lilly and Company

People needed

310

Starts

2016-03-01

Expected to finish

2021-04-27

Last updated by the study team

2022-05-09

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The participant may have no more than 2 prior lines of systemic therapies (neoadjuvant and adjuvant therapies will not be considered as a prior line of therapy) for advanced or metastatic disease and is suitable to receive gemcitabine and docetaxel therapy. All previous therapies must have completed ≥ 3 weeks (21 days) prior to first dose of study drug.
• In the Phase 2 part, prior olaratumab/doxorubicin combination therapy in 1 prior treatment line is allowed.
• Prior olaratumab therapy must have been received with doxorubicin as indicated on the olaratumab label.
• Prior olaratumab therapy must have included at least 2 full cycles of olaratumab/doxorubicin (that is, a minimum of 4 doses of olaratumab).
• Participants, who completed at least 2 cycles of combination olaratumab/doxorubicin therapy then discontinued doxorubicin due to toxicity or maximum dosing and proceeded to olaratumab monotherapy, are eligible.
• The most recent dose of olaratumab must have been received within 180 days of randomization in this study.
• Availability of tumor tissue is mandatory for study eligibility. The participant must have consented to provide archived formalin-fixed paraffin-embedded tumor tissue or be subject to a pre-treatment re-biopsy of primary or metastatic tumor tissue for future central pathology review and translational research (if archived tissue is unavailable).
• The participant has adequate hematologic, organ, and coagulation function within 2 weeks (14 days) prior to enrollment (Phase 1b) or randomization (Phase 2).

You may not qualify if…

• The participant is diagnosed with gastrointestinal stromal tumor (GIST) or Kaposi sarcoma.
• The participant has active central nervous system (CNS) or leptomeningeal metastasis (brain metastasis) at the time of enrollment (Phase 1b) or randomization (Phase 2). Participants with a history of a CNS metastasis previously treated with curative intent (for example, stereotactic radiation or surgery) that have not progressed on follow-up imaging, have been asymptomatic for at least 60 days, and are not receiving systemic corticosteroids and or/anticonvulsants, are eligible. Participants with signs or symptoms of neurological compromise should have appropriate radiographic imaging performed before enrollment (Phase 1b) /randomization (Phase 2) to rule out brain metastasis.
• The participant has received prior treatment with gemcitabine or docetaxel. Note: Participants previously enrolled in the I5B-MC-JGDJ (NCT02451943) or any other blinded study with olaratumab are not eligible to participate in this trial.
• The participant has electively planned or will require major surgery during the course of the study.
• Females who are pregnant or breastfeeding.
• The participant has an active fungal, bacterial, and/or known viral infection including human immunodeficiency virus (HIV) or viral (A, B, or C) hepatitis (screening is not required).

Where it is running

• UCLA Medical Center — Santa Monica, California, United States
• University of Colorado Cancer Center — Aurora, Colorado, United States
• Mayo Clinic-Jacksonville — Jacksonville, Florida, United States
• Sylvester Comprehensive Cancer Center — Miami, Florida, United States
• Georgia Cancer Specialists PC — Atlanta, Georgia, United States
• Johns Hopkins University School of Medicine — Baltimore, Maryland, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Washington University Medical School — St Louis, Missouri, United States
• Nebraska Methodist Cancer Center — Omaha, Nebraska, United States
• Monter Cancer Center — Lake Success, New York, United States
• Columbia University Medical Center — New York, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Ohio State University Medical Center — Columbus, Ohio, United States
• Oklahoma Cancer Specialists & Research Institute, LLC — Tulsa, Oklahoma, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• University of Texas Southwestern Medical Center at Dallas — Dallas, Texas, United States
• University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• Utah Cancer Specialists — Salt Lake City, Utah, United States
• Seattle Cancer Care Alliance — Seattle, Washington, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States
• Royal Adelaide Hospital — Adelaide, South Australia, Australia
• Peter MacCallum Cancer Centre — Melbourne, Victoria, Australia
• Institut Bergonie — Bordeaux, France
• Centre Oscar Lambret — Lille, France

Full record on ClinicalTrials.gov

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