Clinical Trials

Study of Mapatumumab in Combination With Sorafenib in Subjects With Advanced Hepatocellular Carcinoma

Location:

Trial status:

Inactive

Why is this study being done?

The purpose of this study is to evaluate the efficacy and safety of mapatumumab in combination with sorafenib in subjects with advanced hepatocellular carcinoma.

Who is eligible to participate?

Inclusion Criteria:

- Child-Pugh Class A

- BCLC Stage B or C

- Measurable Liver Cancer

- ECOG Performance Status of 0, 1, or 2

- Age 18 years or older

Exclusion Criteria:

- Received prior investigational or non-investigational agent to treat hepatocellular carcinoma

- Previously received mapatumumab and/or sorafenib

- Major surgery within 4 weeks before enrollment

- Minor surgery within 2 weeks before enrollment

- Systemic steroids within 1 week of enrollment

- Hepatic encephalopathy

- History of clinically significant gastrointestinal bleeding

- Gastrointestinal disease resulting in the inability to take oral medication

- History of infection requiring hospitalization or IV antibiotics

- Known brain or spinal cord metastases

- Known HIV infection

- Unstable angina, myocardial infarction, or cerebrovascular accident within 6 months before enrollment

- Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin

- Uncontrolled hypertension

- Using and unable to discontinue use of CYP3A4 inducers

- Pregnant or breast-feeding women

- Acute or chronic severe renal insufficiency

- Hepatitis B virus DNA levels >2,000IU/mL

Last updated: 12/10/2012

NCT ID:

NCT01258608