Hepatocellular Carcinoma MedDRA version: 19.0 Level: PT Classification code 10073071 Term: Hepatocellular carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: cMET Kinase Inhibitor
Product Code: MSC2156119J
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: MSC2156119J
CAS Number: 1100598-30-8
Concentration unit: mg milligram(s)
Conc
Sponsors
Merck KGaA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically confirmed HCC; 2. Child Pugh Class A liver function score; 3. For phase II only: MET+ status 4. Male or female, 18 years of age or older; 5. Measurable disease in accordance with RECIST Version 1.1; 6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1 (inclusive); 7. Previously treated with sorafenib for = 4 weeks and discontinued sorafenib treatment at least 14 days prior to Day 1 due to either intolerance or radiographic progression; 8. Signed and dated informed consent indicating that the subject (or legally acceptable representative if applicable by local laws) has been informed of all the pertinent aspects of the trial prior to enrollment; 9. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other trial procedures; and 10. Life expectancy of at least 3 months as judged by the investigator. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 33 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 33
Exclusion criteria
Exclusion criteria: 1. Prior systemic anticancer treatment for advanced HCC (except for sorafenib as described in the inclusion criteria); 2. Prior treatment with any agent targeting the HGF/c-Met pathway; 3. Local-regional therapy within 4 weeks before Day 1 4. Impaired cardiac function 5. Additional exclusion criteria could apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Determine the recommended phase II dose (RP2D) of MSC2156119J. Evaluate efficacy of MSC2156119J in subjects with MET+ advanced HCC pretreated with sorafenib and Child Pugh class A liver function. ;Secondary Objective: Characterize the single and multiple dose pharmacokinetics (PK) of MSC2156119J. Assess antitumor activity and biochemical response of MSC2156119J. Evaluate safety and tolerability of MSC2156119J. Evaluate the safety and tolerability of MSC2156119J. Evaluate antitumor activity and biochemical response of MSC2156119J;Primary end point(s): Phase Ib: Number of DLTs occuring in Cycle 1 Phase II: Progression-free survival (PFS) status at 12 weeks;Timepoint(s) of evaluation of this end point: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Time to Progression according to RECIST v. 1.1 -Progression free survival according to RECIST v. 1.1 and mRECIST for HCC -Time-to-symptomatic progression according to RECIST v. 1.1 -Overall survival -Best overall response rate -Disease control rate -Biological response rate ;Timepoint(s) of evaluation of this end point: 12 weeks | — |
Countries
Belgium, Germany, Italy, Spain
Contacts
Public ContactCommunication Centre Merck KGaA
Merck KGaA
Outcome results
None listed