A Study of Olaratumab and Doxorubicin in Participants With Advanced Soft Tissue Sarcoma
Condition: Sarcoma, Soft Tissue
MeSH terms: Sarcoma
Intervention: Olaratumab; Doxorubicin
Intervention description: Administered IV; Administered IV
Intervention MeSH terms: Doxorubicin; Olaratumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 49.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess how the body handles olaratumab when it is given with
      another drug called doxorubicin.

      The safety and tolerability of these drugs will be studied. Each participant will complete
      two 21-day cycles in a fixed order. Participants who complete Cycle 2 may continue to receive
      olaratumab + doxorubicin for an additional six 21-day cycles and then may receive olaratumab
      alone until discontinuation criteria are met.

      Screening is required within 21 days prior to first dose.

      Part B was added in October, 2015 to assess how the body handles a higher dose of olaratumab
      when given with doxorubicin.

      Participants may only enroll in one part.
    

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