c-Met Second-Line Hepatocellular Carcinoma

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-18

Study Completion Date

2018-02-14

Brief Summary

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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.

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Detailed Description

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Conditions

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Carcinoma, Hepatocellular

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Phase 1b: Tepotinib 300 mg

Group Type EXPERIMENTAL

Tepotinib

Intervention Type DRUG

Participants received a single oral dose of Tepotinib 300 milligram (mg) in each 21 days treatment cycle until progressive disease, intolerable toxicity, death, or withdrawal from treatment.

Phase 1b: Tepotinib 500 mg

Group Type EXPERIMENTAL

Tepotinib

Intervention Type DRUG

Participants received a single oral dose of Tepotinib 500 mg daily in each 21 days treatment cycle until progressive disease, intolerable toxicity, death, or withdrawal from treatment.

Phase 2: Tepotinib 500 mg

Group Type EXPERIMENTAL

Tepotinib

Intervention Type DRUG

Participants received a single oral dose of Tepotinib 500 mg daily in each 21 days treatment cycle until progressive disease, intolerable toxicity, death, or withdrawal from treatment.

Interventions

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Tepotinib

Participants received a single oral dose of Tepotinib 300 milligram (mg) in each 21 days treatment cycle until progressive disease, intolerable toxicity, death, or withdrawal from treatment.

Intervention Type DRUG

Tepotinib

Participants received a single oral dose of Tepotinib 500 mg daily in each 21 days treatment cycle until progressive disease, intolerable toxicity, death, or withdrawal from treatment.

Intervention Type DRUG

Other Intervention Names

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MSC2156119J MSC2156119J

Eligibility Criteria

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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

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No