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MSC2156119J

Phase 1

Solid Tumors | Small molecule | Oncology |Merck KGaA|Last Updated: Aug 6, 2020

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

Clinical trial landscape

MSC2156119J · 1 trial · 1 indication

Phase 1 1
NCT01832506A Japanese Phase 1 Trial of c-Met Inhibitor MSC2156119J in Subjects With Solid TumorsSolid Tumors
COMPLETED12 Analytics
PHASE1COMPLETED
A Japanese Phase 1 Trial of c-Met Inhibitor MSC2156119J in Subjects With Solid Tumors
Solid TumorsUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Subjects Experiencing Dose Limiting Toxicity (DLT)
Cycle 1 (Day 1 up to 21)

DLT: defined using National Cancer Institute Common Toxicity Criteria for Adverse Events Version 4.0, as any of following toxicities: Grade 4 neutropenia for more than 7 days; greater than or equal to (\>=) Grade 3 febrile neutropenia; Grade 4 or Grade 3 thrombocytopenia with bleeding; \>=Grade 3 nausea despite adequate treatment; \>=Grade 3 any non-hematological AE (DLT defined specifically for following cases: \>=Grade 3 liver adverse event \[AE\] requiring recovery period of more than 7 days or to Grade 1 without liver metastases or Grade 2 with liver metastases ; \>=Grade 3 lipase and/or amylase elevation with confirmation of pancreatitis. An isolated lipase and/or amylase elevation of \>=Grade 3 without clinical/radiological evidence of pancreatitis was not classified as DLT); and \>=Grade 2 any AE not otherwise defined as DLT that, due to prolonged recovery to Grade 1 (or less) or baseline status, led to delay of treatment with IMP for more than 21 days.

Secondary Endpoints

Number of Subjects With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs or TEAEs Leading To Death
Baseline Up to 30 days after last dose of study drug administration (55.1 weeks)
Number of Subjects With Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score of 2 or Higher
Baseline up to 30 days after last dose of study drug administration (55.1 weeks)
Maximum Plasma Concentration (Cmax) After Single Dose of MSC2156119J
pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
MSC2156119JEXPERIMENTAL -

Interventions

NameTypeDescription
MSC2156119JDRUGSubjects 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.
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Eligibility Criteria

Age Range20 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

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 perform...

Countries:Japan
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Solid Tumors")

Frequently asked questions about MSC2156119J

What is MSC2156119J used for?

MSC2156119J is an investigational small molecule being studied for the treatment of solid tumors. It is currently in Phase 1 clinical development, and a completed trial in Japan evaluated its safety and tolerability in patients with solid tumors.

What does MSC2156119J target?

MSC2156119J is a c-Met inhibitor. It targets the c-Met receptor tyrosine kinase, which is involved in tumor growth and progression. By inhibiting c-Met, the drug aims to interfere with signaling pathways that promote cancer cell proliferation and survival.

Who is developing MSC2156119J?

MSC2156119J is being developed by Merck KGaA, a German multinational pharmaceutical company. The company's stock is traded under the ticker symbol MKGAF.

What phase is MSC2156119J in?

MSC2156119J is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 trial has been completed, and the drug remains under investigation for solid tumors.

What clinical trials is MSC2156119J in?

MSC2156119J has one completed clinical trial, NCT01832506, titled 'A Japanese Phase 1 Trial of c-Met Inhibitor MSC2156119J in Subjects With Solid Tumors.' This trial enrolled 12 participants in Japan and was not randomized or blinded.