Completed
A Japanese Multicenter, Open Label, Phase I Trial of c-Met Inhibitor MSC2156119J Given Orally as Monotherapy to Subjects With Solid Tumors
What is being tested
MSC2156119J
Drug
Who is being recruted
Over 20 Years
+26 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 1
Interventional
Study Start: April 2013
Summary
Principal SponsorMerck KGaA, Darmstadt, Germany
Last updated: August 6, 2020
Sourced from a government-validated database.Claim as a partner
Study start date: April 30, 2013
Actual date on which the first participant was enrolled.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.
Principal SponsorMerck KGaA, Darmstadt, Germany
Last updated: August 6, 2020
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
12 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 20 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
6 inclusion criteria required to participate
A Japanese male or female, age greater than or equal to ( >= ) 20 years
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
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 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
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20 exclusion criteria prevent from participating
Hematological test abnormalities
History of receiving treatment with any c-Met signaling pathway inhibitor
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
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Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
Research site
Shizuoka, JapanCompleted2 Study Centers