A Japanese Phase 1 Trial of c-Met Inhibitor MSC2156119J in Subjects With Solid Tumors
Condition: Solid Tumors
MeSH terms: Neoplasms
Intervention: MSC2156119J
Intervention description: Subjects will be administered with MSC2156119J 215 mg, 300 mg and 500 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Solid Tumors; MSC2156119J; c-Met inhibitor; Japanese; Phase 1

Summary:

      This is a Japanese multicenter, open-label, Phase 1 study to evaluate safety and efficacy of
      MSC2156119J in subjects with malignant solid tumor which is refractory to standard therapy or
      to which no effective standard therapy is applicable.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A subject with a histologically or cytologically confirmed diagnosis of malignant
             solid tumor which is refractory to standard therapy or to which no effective standard
             therapy is applicable

          -  An archived tumor tissue is available or biopsy of tumor tissues can be newly
             performed

          -  A Japanese male or female, age greater than or equal to (>=) 20 years

          -  A subject who has read the Subject Information Sheet and understood the details of
             this clinical trial, and is willing and able to give his/her informed consent.

          -  A female of child-bearing potential must have a negative blood pregnancy test result
             at her screening period. A female subject of child-bearing potential must be willing
             to avoid pregnancy by using an adequate method of contraception Life expectancy is at
             least 3 months

          -  Other inclusion criteria apply

        Exclusion Criteria:

          -  Known Human immunodeficiency virus (HIV) positivity, active hepatitis C, or active
             hepatitis B

          -  Presence of liver fibrosis or liver cirrhosis that has been histologically diagnosed

          -  Signs or symptoms that suggest transmissible spongiform encephalopathy

          -  Received major surgery within 6 weeks before Day 1 in Cycle 1

          -  Known drug abuse or alcohol abuse

          -  Known hypersensitivity to any of the trial treatment ingredients

          -  Hematological test abnormalities

          -  Renal impairment as defined in the protocol

          -  Liver dysfunction as defined in the protocol

          -  History or presence of central nervous system metastasis

          -  History or presence of disease or condition that may hamper compliance or absorption
             of the investigational medicinal product (IMP) due to difficulty in swallowing or
             absorption

          -  Poor performance status of Eastern Cooperative Oncology Group Performance status (ECOG
             PS) >= 2

          -  Received any anti-cancer therapy days Received extensive prior radiotherapy that
             irradiates more than 30 percent of bone marrow

          -  Received any radiotherapy within 4 weeks before Day 1 in Cycle 1

          -  Pregnancy and lactation period

          -  History of receiving treatment with any c-Met signaling pathway inhibitor

          -  Participation in another interventional clinical trial within the past 30 days from
             Day 1 in Cycle 1

          -  Other significant disease that in the Investigator's opinion would exclude the subject
             from the trial

          -  Legal incapacity or limited legal capacity

          -  Other exclusion criteria apply