A Japanese Phase 1 Trial of c-Met Inhibitor MSC2156119J in Subjects With Solid Tumors

Merck KGaA (EMD Serono)

Status and phase

Completed

Phase 1

Conditions

Solid Tumors

Treatments

Drug: MSC2156119J

Study type

Interventional

Funder types

Industry

Identifiers

NCT01832506

EMR 200095-003

Details and patient eligibility

About

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.

Enrollment

12 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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