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c-Met Second-Line Hepatocellular Carcinoma

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ClinicalTrials.gov Identifier: NCT02115373
Recruitment Status : Completed
First Posted : April 16, 2014
Last Update Posted : October 15, 2018
Sponsor:
Information provided by (Responsible Party):
Merck KGaA, Darmstadt, Germany

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Carcinoma, Hepatocellular Drug: MSC2156119J Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Single Arm, Phase Ib/II Study to Evaluate Efficacy, Safety, and PK of MSC2156119J as Monotherapy in Subjects With MET+ Advanced Hepatocellular Carcinoma With Child Pugh Class A Liver Function Who Have Failed Sorafenib Treatment
Actual Study Start Date : May 18, 2014
Actual Primary Completion Date : February 14, 2018
Actual Study Completion Date : February 14, 2018

Arm Intervention/treatment
Experimental: MSC2156119J Drug: MSC2156119J
MSC2156119J tablet will be administered in a total dose of 300 to 500 milligram (mg) orally once daily for repeated 21-day cycles until disease progression, intolerable toxicity, death, or withdrawal from treatment.




Primary Outcome Measures :
  1. Number of Dose limiting toxicities (DLTs) occurring in Cycle 1 [ Time Frame: up to Day 21 of Cycle 1 ]

Secondary Outcome Measures :
  1. Time to Progression according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 [ Time Frame: Time from first study drug administration to the date of first occurrence of radiological progressive disease (PD) assessed on Day 1 of Cycles 3, 5, 7, 9, 11, 13 thereafter every 4 cycles up to 12 months after last subject's first dose ]
  2. Progression free survival (PFS) according to RECIST version 1.1 and modified Response Evaluation Criteria in Solid Tumors (mRECIST) for HCC [ Time Frame: Time from first study drug administration to either first occurrence of radiological PD or death due to any cause within 12 weeks of the last tumor assessment or up to 12 months after last subject's first dose, whichever occurs first ]
  3. Time-to-symptomatic progression according to RECIST version 1.1 [ Time Frame: Time from first study drug administration to date of deterioration of symptoms or deterioration to Eastern Cooperative Oncology Group (ECOG) performance score 4 or death or up to 12 months after last subject's first dose whichever occurs first ]
  4. Overall survival [ Time Frame: Time from first study drug administration until death or up to 12 months after last subject's first dose whichever occurs first ]
  5. Best overall response rate [ Time Frame: Time from first study drug administration until first occurrence of radiological PD assesses on Day 1 of Cycles 3, 5, 7, 9, 11, 13 thereafter every 4 cycles up to 12 months after last subject's first dose ]
  6. Disease control rate [ Time Frame: Time from first study drug administration until first occurrence of radiological PD assessed on Day 1 of Cycles 3, 5, 7, 9, 11, 13 thereafter every 4 cycles up to 12 months after last subject's first dose ]
  7. Biological response rate [ Time Frame: Baseline and Day 21 of Cycle 2 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02115373


Locations
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Germany
Please contact the Merck KGaA Communication Center located in
Darmstadt, Germany
Sponsors and Collaborators
Merck KGaA, Darmstadt, Germany
Investigators
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Study Director: Medical Responsible Merck KGaA, Darmstadt, Germany

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Responsible Party: Merck KGaA, Darmstadt, Germany
ClinicalTrials.gov Identifier: NCT02115373     History of Changes
Other Study ID Numbers: EMR 200095_005
2013-002053-30 ( EudraCT Number )
First Posted: April 16, 2014    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018

Keywords provided by Merck KGaA, Darmstadt, Germany:
Hepatocellular Carcinoma
c-Met inhibitor
Phase 1b
Sorafenib
MSC2156119J

Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Sorafenib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action