Study of the Safety and Pharmacokinetics of Olaratumab (IMC-3G3) in Japanese Participants With Solid Tumors
Condition: Malignancy; Metastasis
MeSH terms: Neoplasm Metastasis; Neoplasms
Intervention: Olaratumab
Intervention description: Cohort 1 10 milligrams/kilogram (mg/kg) intravenously (IV) administered on Days 1 and 8, every 3 weeks; Cohort 2 20 mg/kg IV administered every 2 weeks; Cohort 3 15 mg/kg IV administered on Days 1 and 8, every 3 weeks
Intervention MeSH terms: Olaratumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      Participants in this single-center, open-label, dose-escalation, Phase 1 study will initially
      receive intravenous (IV) olaratumab once every 2 weeks or on Days 1 and 8 every 3 weeks for 6
      weeks (one cycle). After the first cycle, participants experiencing an overall response of
      complete response (CR), partial response (PR), or stable disease (SD) will continue to
      receive olaratumab at their cohort dose and schedule until there is evidence of progressive
      disease (PD), or until other withdrawal criteria are met.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Solid tumor that has been histopathologically or cytologically documented

          -  Advanced primary or recurrent solid tumor participants who has not responded to
             standard therapy or for whom no standard therapy is available

          -  Measurable or nonmeasurable lesions

          -  An Eastern Cooperative Oncology Group Performance Status score of 0-1

          -  Able to provide informed consent

          -  Has a life expectancy of >3 months

          -  Adequate hematologic function

          -  Adequate hepatic function

          -  Has adequate renal function

          -  Agrees to use adequate contraception for the duration of study participation and for
             at least 12 weeks after the last dose of study therapy

          -  Adequate recovery from recent surgery, chemotherapy, and radiation therapy (including
             palliative radiation therapy). At least 28 days (6 weeks for nitrosoureas or mitomycin
             C) must have elapsed from major surgery, prior chemotherapy, prior treatment with an
             investigational agent or device, or prior radiation therapy. For treatment with
             non-approved monoclonal antibodies, a minimum of 8 weeks must have elapsed

          -  Is willing to comply with study procedures until the End-of-Therapy visit

        Exclusion Criteria:

          -  Received chemotherapy or therapeutic radiotherapy within 28 days (6 weeks for
             nitrosoureas or mitomycin C) prior to entering the study, or has ongoing side effects
             ≥ Grade 2 due to agents administered more than 28 days earlier

          -  Has undergone major surgery [example (e.g.), laparotomy, thoracotomy, removal of
             organ(s)] within 28 days prior to study entry

          -  Elective or planned surgery to be conducted during the trial

          -  Documented and/or symptomatic brain or leptomeningeal metastases (participants who are
             clinically stable [no symptoms during the 4 weeks prior to study entry] with an
             assessment that no further treatment [radiation, surgical excision, or administration
             of steroids] is required are permitted to enter the study)

          -  Uncontrolled intercurrent illness including, but not limited to:

               -  Active infection requiring systemic antibiotic treatment excluding oral
                  administration [≥Grade 3 National Cancer Institute - Common Terminology Criteria
                  for Adverse Events [NCI-CTCAE Version (v) 4.02)]

               -  Congestive heart failure (Class III or IV per the New York Heart Association
                  classification for heart disease)

               -  Angina pectoris, angioplasty, stenting, or myocardial infarction within 6 months

               -  Uncontrolled hypertension [systolic blood pressure >150 millimeters of mercury
                  (mm Hg), diastolic blood pressure >95 mm Hg]

               -  Cardiac arrhythmia requiring treatment (NCI-CTCAE v4.02, or asymptomatic
                  sustained ventricular tachycardia

               -  Peripheral neuropathy of any etiology ≥Grade 2 (NCI-CTCAE v4.02); or

               -  Any other serious uncontrolled medical disorder(s) in the opinion of the
                  investigator

          -  Participated in clinical studies of non-approved experimental agents or procedures
             within 4 weeks prior to study for small molecules, or 8 weeks prior to study entry for
             non-approved monoclonal antibodies

          -  Received any previous treatment with agents targeting the platelet-derived growth
             factor (PDGF) or platelet-derived growth factor receptor (PDGFR), approved or
             non-approved

          -  Known allergy to any of the treatment components (IMC-3G3, histidine, glycine, sodium
             chloride, mannitol, or polysorbate)

          -  If female, is pregnant (confirmed by urine or serum pregnancy test) or lactating

          -  Known alcohol or drug dependency

          -  Hepatitis B virus (HBV) antigen-, hepatitis C virus (HCV) antibody-, or human
             immunodeficiency (HIV) antibody-positive [asymptomatic healthy carriers with
             detectable HBV-Deoxyribonucleic acid (DNA), HCV-Ribonucleic acid (RNA) may be enrolled
             into the trial]

          -  Assessed as inadequate for the study by the investigator