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 - c-Met Second-line HCC

Phase 1

• Conditions: Hepatocellular Carcinoma; MedDRA 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-IT
• Lead Sponsor: Merck KGaA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-02-07
• Study Completion: 2018-02-14
• Last Update Posted: 21 December 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 66

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified