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A Japanese Multicenter, Open Label, Phase I Trial of c-Met Inhibitor MSC2156119J Given Orally as Monotherapy to Subjects With Solid Tumors

Phase 1
20 Years
Open (Enrolling)
Solid Tumors

Thank you

Trial Information

A Japanese Multicenter, Open Label, Phase I Trial of c-Met Inhibitor MSC2156119J Given Orally as Monotherapy to Subjects With Solid Tumors

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

- 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

- Poor performance status of Eastern Cooperative Oncology Group Performance status
(ECOG PS) greater than or equal to 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of subjects experiencing Dose Limiting Toxicity

Outcome Time Frame:

up to Day 21 of Cycle 1

Safety Issue:


Principal Investigator

Kotaro Funato

Investigator Role:

Study Director

Investigator Affiliation:

Merck Serono Co., Ltd., Japan


Japan: Pharmaceuticals and Medical Devices Agency

Study ID:

EMR 200095-003



Start Date:

April 2013

Completion Date:

April 2014

Related Keywords:

  • Solid Tumors
  • Solid Tumors
  • MSC2156119J
  • c-Met inhibitor
  • Japanese
  • Phase 1
  • Neoplasms