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

• Status: Completed
• Trial end date: 2014-10-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck KGaA; Merck KGaA, Darmstadt, Germany

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