Status:
COMPLETED
A Japanese Phase 1 Trial of c-Met Inhibitor MSC2156119J in Subjects With Solid Tumors
Lead Sponsor:
Merck KGaA, Darmstadt, Germany
Conditions:
Solid Tumors
Eligibility:
All Genders
20+ years
Phase:
PHASE1
Brief 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 e...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 30 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2014
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01832506
Start Date
April 30 2013
End Date
October 31 2014
Last Update
August 6 2020
Active Locations (2)
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1
Research site
Kashiwa, Japan
2
Research site
Shizuoka, Japan