A Multicenter, Single Arm, Phase Ib/II Study to Evaluate Efficacy, Safety, and PK ofMSC2156119J as Monotherapy in Subjects with MET+ Advanced Hepatocellular Carcinoma withChild Pugh Class A Liver Function Who Have Failed Sorafenib Treatment
- Conditions
- Hepatocellular CarcinomaMedDRA version: 16.1Level: PTClassification code 10073071Term: Hepatocellular carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2013-002053-30-ES
- Lead Sponsor
- Merck KGaA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 66
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Determine the recommended phase II dose (RP2D) of MSC2156119J.<br><br>Evaluate efficacy of MSC2156119J in subjects with MET+ advanced HCC pretreated with sorafenib and<br>Child Pugh class A liver function.;Secondary Objective: Characterize the single and multiple dose pharmacokinetics (PK) of MSC2156119J.<br>Assess antitumor activity and biochemical response of MSC2156119J.<br>Evaluate safety and tolerability of MSC2156119J.<br><br><br>Evaluate the safety and tolerability of MSC2156119J.<br>Evaluate antitumor activity and biochemical response of MSC2156119J;Primary end point(s): Phase Ib: Number of DLTs occuring in Cycle 1<br><br>Phase II: Progression-free survival (PFS) status at 12 weeks;Timepoint(s) of evaluation of this end point: 12 weeks
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - Time to Progression according to RECIST v. 1.1<br>-Progression free survival according to RECIST v. 1.1 and mRECIST for HCC<br>-Time-to-symptomatic progression according to RECIST v. 1.1<br>-Overall survival<br>-Best overall response rate<br>-Disease control rate<br>-Biological response rate;Timepoint(s) of evaluation of this end point: 12 weeks