c-Met Second-Line Hepatocellular Carcinoma

Merck KGaA (EMD Serono)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Carcinoma, Hepatocellular

Treatments: Drug: Tepotinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT02115373

EMR 200095_005

2013-002053-30 (EudraCT Number)

Details and patient eligibility

About

This is a Phase 1b/2, multicenter, single arm trial to assess the efficacy, safety, and pharmacokinetics (PK) of MSC2156119J as monotherapy in subjects with MET+ advanced hepatocellular carcinoma (HCC) with child Pugh Class A liver function who have failed sorafenib treatment.

Enrollment: 66 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically confirmed HCC
• Child Pugh Class A liver function score
• For Phase 2 only: MET+ status
• Male or female, 18 years of age or older
• Measurable disease in accordance with Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1 (inclusive)
• Availability of a pretreatment tumor biopsy (excluding fine needle aspiration and cytology samples) taken after the subject has discontinued sorafenib and within 28 days before the day of first dosing with MSC2156119J. From the pretreatment biopsy either a formalin-fixed (formalin fixation is mandatory) paraffin-embedded block with tumor tissue (preferred) or at least 15 unstained slides must be sent to the central laboratory prior to enrollment. An associated pathology report must also be sent with the sample
• Previously treated with sorafenib for greater than or equal to 4 weeks and discontinued sorafenib treatment at least 14 days prior to Day 1 due to either intolerance or radiographic progression
• 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
• Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other trial procedures
• Life expectancy of at least 3 months as judged by the investigator

Exclusion criteria

• Prior systemic anticancer treatment for advanced HCC (except for sorafenib as described in the inclusion criteria)
• Prior treatment with any agent targeting the hepatocyte growth factor (HGF)/c-Met pathway
• Local-regional therapy within 4 weeks before Day 1
• Impaired cardiac function
• Other protocol defined exclusion criteria could apply

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

66 participants in 3 patient groups

Phase 1b: Tepotinib 300 mg

Experimental group

Treatment:

Drug: Tepotinib

Drug: Tepotinib

Phase 1b: Tepotinib 500 mg

Experimental group

Treatment:

Drug: Tepotinib

Drug: Tepotinib

Phase 2: Tepotinib 500 mg

Experimental group

Treatment:

Drug: Tepotinib

Drug: Tepotinib