A Study of IMC-A12 in Combination With Sorafenib in Participants With Advanced Cancer of the Liver
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Intervention: IMC-A12 (cixutumumab) - 10 milligrams/kilogram (mg/kg); IMC-A12 (cixutumumab) - 20 mg/kg; Sorafenib
Intervention description: intravenous infusions 10 mg/kg on Day 1 of each 3-week cycle; intravenous infusions 20 mg/kg on Day 1 of each 3-week cycle; 400 milligrams (mg) twice per day orally
Intervention MeSH terms: Sorafenib; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 47.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hepatocellular Carcinoma; Liver Neoplasms; Antibodies, Monoclonal

Summary:

      To determine if IMC-A12 given in combination with Sorafenib is safe and effective for
      participants with advanced liver cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The participant has histologically or cytologically confirmed, unresectable HCC

          -  The participant has at least one target lesion measurable according to Response
             Evaluation Criteria in Solid Tumors (RECIST) guidelines. Target lesion(s) must not lay
             within a previously irradiated, ablated, or chemoembolized area. If a lesion does lie
             in such an area, there must be evidence of growth on successive imaging studies,
             including tumor hypervascularity, in order for such a lesion to be considered a target
             lesion

          -  The participant has not received prior systemic therapy for HCC. Participants may have
             received prior embolization, chemoembolization, intra-arterial chemotherapy infusion,
             ethanol injection, radiofrequency ablation, or cryosurgery

          -  The participant has fasting serum glucose <160 milligrams/deciliter (mg/dL) or below
             the upper limit of normal (ULN) and/or hemoglobin A1C <7%. If baseline nonfasting
             glucose <160 mg/dL, fasting glucose measurement is not required

          -  The participant has the ability to understand and the willingness to sign a written
             informed consent document

        Exclusion Criteria:

          -  The participant has brain metastases

          -  The participant has acute hepatitis

          -  The participant has poorly controlled diabetes mellitus. Participants with a history
             of diabetes mellitus are allowed to participate, provided that their blood glucose is
             within normal range and that they are on a stable dietary or therapeutic regimen for
             this condition

          -  The participant has congestive heart failure > class II New York Heart Association
             (NYHA), unstable angina pectoris, new onset of angina pectoris, myocardial infarction
             within the past 6 months, or cardiac ventricular arrhythmias requiring antiarrhythmic
             therapy

          -  The participant has experienced a hemorrhage or bleeding event ≥ National Cancer
             Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade 3 within 4
             weeks prior first dose of study therapy