Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 1:20 AM
NCT ID:
NCT01988493
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed HCC
* Participants were either intermediate HCC of BCLC Stage B, who were not eligible for surgical and/or local-regional therapies or who had progressive disease (PD) after surgical and/or local-regional therapies (note: the local-regional therapy must not contain sorafenib), or advanced HCC of BCLC Stage C
* Participants who had disease progression on or were intolerant to the prior standard treatment for advanced HCC (phase Ib Korean subjects only)
* A tumor biopsy was required for determining MET status
* MET+ status (Phase 2 only), as determined by the central laboratory (Phase 1b retrospectively, Phase 2 for participant selection) were defined in the protocol
* Child-Pugh class A with no encephalopathy according to the screening assessment
* Asian male or female, 18 years of age or older
* Measurable disease in accordance with RECIST v1.1 (Phase 2 only)
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2
* Eligible for treatment with sorafenib, was assessed by investigators according to the Package Insert and clinical judgment (Phase 2 only)
* Signed and dated informed consent indicating that the participants had 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 was judged by the investigator of at least 3 months
Exclusion Criteria:
* Prior systemic anticancer treatment for advanced HCC, included targeted therapy (for example, sorafenib), chemotherapy, or any other investigational agent (Phase 2 only)
* Prior treatment with any agent targeting the hepatocyte growth factor (HGF)/c-Met pathway
* Prior local-regional therapy within 4 weeks prior to Day 1 of trial treatment
* Prior history of liver transplant
* Laboratory index at baseline were defined in the protocol
* Past or current history of neoplasm other than HCC, except for curatively treated non-melanoma skin cancer, in situ carcinoma of the cervix, or other cancer curatively treated and with no evidence of disease for at least 5 years
* Known central nervous system (CNS) or brain metastasis that is either symptomatic or untreated
* Medical history of difficulty swallowing, malabsorption, or other chronic gastrointestinal disease, or conditions that may hamper compliance and/or absorption of the tested products
* Clinically significant gastrointestinal bleeding within 4 weeks before trial entry
* Peripheral neuropathy Grade greater than or equal to 2 (Common Terminology Criteria for Adverse Events \[CTCAE\] v4.0)
* Impaired cardiac function was defined in the protocol
* Hypertension uncontrolled by standard therapies
* Participants with a family history of long QT syndrome or who take any agent that is known to prolong QT/QTc interval
* Known human immunodeficiency virus (HIV) infection
* Particpants who had acute pancreatitis and/or chronic pancreatitis, with elevated lipase and/or amylase, clinical symptoms, and/or imaging studies that are indicative of the diagnosis (Mainland Chinese participants only)
* Known or suspected drug hypersensitivity to any ingredients of sorafenib (Phase 2 only) and MSC2156119J
* Female participants who were pregnant or lactating, or males and females of reproductive potential not willing or not able to employ a highly effective method of birth control/contraception to prevent pregnancy from 2 weeks before receiving study drug until 3 months after receiving the last dose of study drug
* Concurrent treatment with a non-permitted drug
* Substance abuse, other acute or chronic medical or psychiatric condition, or laboratory abnormalities that may increase the risk associated with trial participation in the opinion of the investigator
* Participation in another clinical trial within the past 28 days
* Previous anticancer treatment-related toxicities not recovered to baseline or Grade 0-1 (except alopecia and peripheral neuropathy)
* Participants with any concurrent medical condition or disease that will potentially compromise the conduct of the study at the discretion of the investigators
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01988493
Study Brief:
Protocol Section:
NCT01988493