A Study of Olaratumab in Japanese Participants With Advanced Cancer
Condition: Neoplasm
Intervention: Olaratumab; Doxorubicin
Intervention description: Administered IV; Administered IV
Intervention MeSH terms: Doxorubicin; Olaratumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      This study consists of 2 parts (Part A and Part B). The main purpose of Part A is to evaluate
      safety and side effects of olaratumab in combination with doxorubicin in Japanese
      participants with a group of rare cancers (advanced solid tumors, especially advanced soft
      tissue sarcoma [STS].) The main purpose of Part B is to evaluate how much olaratumab gets
      into the blood stream of Japanese participants with advanced solid tumors and how long it
      takes the body to get rid of it.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Part A: Have histological or cytological evidence of a diagnosis of advanced or
             metastatic solid tumor, especially STS, which is not amenable to treatment with
             surgery or radiotherapy. Part B: Have histological or cytological evidence of a
             diagnosis of solid tumor that is advanced or metastatic.

          -  Have the presence of measurable or nonmeasurable disease as defined by the Response
             Evaluation Criteria in Solid Tumors (RECIST).

          -  Have given written informed consent prior to any study-specific procedures.

          -  Have adequate organ and coagulation function

          -  Have an Eastern Cooperative Oncology Group (ECOG) performance score (PS) of less than
             or equal to 1.

          -  Have discontinued previous treatments for cancer and recovered from the acute effects
             of therapy.

          -  (Part A only) Have a prestudy echocardiogram with an actual left ventricular ejection
             fraction greater than or equal to 50%, within 21 days prior to first dose of study
             medication.

          -  All participants agree to use a reliable method of birth control and to not donate
             sperm during the study and for at least 3 months following last dose of study drug.

          -  Female participants:

               -  must either be women not of child-bearing potential due to surgical sterilization
                  confirmed by medical history, or menopause or

               -  women of child-bearing potential who test negative for pregnancy within 7 days
                  before the first dose of study drug based on serum or urine pregnancy test and
                  agree not to breast feed during the study and for 3 months following the last
                  dose of the study drug(s)

          -  Have an estimated life expectancy of more than or equal to 3 months in the judgment of
             the investigator.

        Exclusion Criteria:

          -  Have received treatment within 21 days of the initial dose of study drug with an
             investigational product or non-approved use of a drug or device for non-cancer
             indications or are concurrently enrolled in any other type of medical research judged
             not to be scientifically or medically compatible with this study.

          -  (Part A only) Have received prior treatment with doxorubicin, daunorubicin,
             idarubicin, and/or other anthracyclines and anthracenediones

          -  (Part A only) Have received prior radiation therapy to the mediastinal/pericardial
             area.

          -  Have symptomatic central nervous system malignancy or metastasis. Participants with
             treated central nervous system (CNS) metastases are eligible for this study if they
             are not currently receiving corticosteroids and/or anticonvulsants, and their disease
             is asymptomatic and radiographically stable for at least 60 days.

          -  Have an elective or a planned major surgery to be performed during the course of the
             study.

          -  Have an uncontrolled intercurrent illness including, but not limited to, symptomatic
             congestive heart failure greater than class II of the New York Heart Association
             guideline, severe myocardial insufficiency, cardiac arrhythmia, or psychiatric
             illness/social situations that would limit compliance with study requirements.

          -  Have unstable angina pectoris, angioplasty, cardiac stenting, or myocardial infarction
             6 months prior to study entry.

          -  Have a known allergy to any of the treatment components.

          -  Have a history of allergic reactions attributed to compounds of chemical or biologic
             composition similar to that of olaratumab.

          -  Have a known active fungal, bacterial, and/or known viral infection

          -  Have a corrected QT interval of greater than 470 milliseconds (msec) on screening
             electrocardiogram (ECG)

          -  Have a second primary malignancy that, in the judgment of the investigator and
             sponsor, may affect the interpretation of results.