A Study of Olaratumab and Doxorubicin in Participants With Advanced Soft Tissue Sarcoma

Launched by ELI LILLY AND COMPANY · Dec 22, 2014

Keywords

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Gender

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Eligibility criteria

• Inclusion Criteria:
• • Have histological or cytological evidence of a diagnosis of soft tissue sarcoma (STS) that is advanced and/or metastatic
• • Have the presence of measurable and/or nonmeasurable disease
• • Have given written informed consent prior to any study-specific procedures
• • Have a performance status of less than or equal to 2 on the Eastern Cooperative Oncology Group (ECOG) scale
• • Have discontinued previous treatments for cancer and recovered from the acute effects of therapy
• • Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
• Exclusion Criteria:
• • Have received treatment within 28 days of the initial dose of study drug with an investigational product or non-approved use of a drug or device for noncancer indications
• • Have received prior treatment with doxorubicin, daunorubicin, idarubicin, and/or other anthracyclines and anthracenediones
• • Have active central nervous system (CNS) metastasis. Participants with treated CNS metastases are eligible for this study if they are not currently receiving corticosteroids
• • Have unstable hepatic disease with a grade equal to or greater than Child-Pugh B
• • Have an active fungal, bacterial, and/or known viral infection including human immunodeficiency virus (HIV) or viral (A, B, or C) hepatitis
• • Have a history of another primary cancer, with the exception of a) curatively resected nonmelanoma skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor treated with curative intent, no known active disease present, and no treatment administered during the last 3 years prior to study entry
• • Have a history of chronic heart failure or left ventricular dysfunction
• • Have a resting heart rate of less than (\<)50 beats per minute (bpm) or greater than (\>)100 bpm
• • Have a history of radiation therapy involving the mediastinal/pericardial area. Previous radiation therapy is allowed but must not have included whole pelvis radiation