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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2014-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Solid Tumors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MSC2156119J

Group Type EXPERIMENTAL

MSC2156119J

Intervention Type DRUG

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.

Interventions

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MSC2156119J

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.

Intervention Type DRUG

Eligibility Criteria

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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

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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No