Last updated on August 2018

A Study of Ramucirumab (LY3009806) Versus Placebo in Participants With Hepatocellular Carcinoma and Elevated Baseline Alpha-Fetoprotein


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: HEPATOCELLULAR CARCINOMA
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  • A diagnosis of HCC based on histopathologic findings, or a diagnosis of cirrhosis and a tumor with classical HCC imaging characteristics.
  • Sorafenib was the only systemic therapy for HCC and was discontinued for disease progression or intolerance (Main Global and ME2 Cohorts only).
  • The participant received one prior systemic therapy regimen, excluding prior sorafenib, for the treatment of HCC (OLE Cohort only).
  • 1 measurable lesion per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 that has not been previously treated with locoregional therapy. A participant with a lesion(s) that has previously been treated with locoregional therapy is also eligible, if the lesion has documented progression after locoregional treatment and is measureable.
  • Child-Pugh score <7 (Child-Pugh Class A).
  • Barcelona Clinic Liver Cancer (BCLC) Stage C disease or BCLC Stage B disease not amenable to locoregional therapy or refractory to locoregional therapy.
  • Baseline AFP 400 nanograms/milliliter.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Resolution of all clinically significant toxic effects of prior therapy.
  • Total bilirubin 1.5 times upper limit of normal value (ULN), aspartate transaminase (AST) and alanine transaminase (ALT) 5 ULN.
  • Creatinine clearance 60 milliliters/minute.
  • Urinary protein is 1+ on dipstick or routine urinalysis or 24-hour urine demonstrating <1 gram of protein.
  • Absolute neutrophil count 1.0 10^9/Liter, hemoglobin 9 grams/deciliter, and platelets 75 10^9/Liter.
  • International Normalized Ratio (INR) 1.5 and a partial thromboplastin time (PTT) 5 seconds above the ULN.
  • Surgically sterile, postmenopausal, or compliant with a highly effective contraceptive method.
  • If a woman of childbearing potential, a negative serum pregnancy test prior to randomization.
  • Willing to provide blood for research.

Exclusion Criteria:

  • Fibrolamellar carcinoma or mixed hepatocellular cholangiocarcinoma.
  • Concurrent malignancy. Participants with carcinoma in situ of any origin and participants with prior malignancies in remission may be eligible with sponsor approval.
  • Previous brain metastases, leptomeningeal disease, or uncontrolled spinal cord compression.
  • History of or current hepatic encephalopathy or clinically meaningful ascites.
  • Ongoing or recent hepatorenal syndrome.
  • Liver transplant.
  • Hepatic locoregional therapy following prior systemic therapy or within 28 days prior to randomization.
  • Major surgical procedure, traumatic injury, non-healing wound, or peptic ulcer 28 days prior to randomization.
  • Placement of a subcutaneous venous access device within 7 days prior to the first dose of study treatment unless the procedure is judged of low risk of bleeding.
  • Enrolled in a clinical trial involving an investigational product or nonapproved use of a drug or in medical research judged not to be scientifically or medically compatible with this study.
  • Discontinued from study treatment from another clinical trial within 28 days prior to randomization.
  • Known allergy to any of the treatment components.
  • Uncontrolled hypertension.
  • Any arterial thrombotic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, <6 months prior to randomization.
  • Any bleeding episode considered life-threatening, or any Grade 3 or 4 gastrointestinal bleeding episode in the 3 months prior to randomization requiring intervention.
  • Esophageal or gastric varices that require intervention or represent high bleeding risk. Participants with evidence of portal hypertension or prior bleeding must have had endoscopic evaluation within 3 months prior to randomization.
  • Gastrointestinal perforation or fistulae within 6 months prior to randomization.
  • Symptomatic congestive heart failure (New York Heart Association II-IV), unstable angina pectoris, or symptomatic or poorly controlled cardiac arrhythmia.
  • Pregnant or breast-feeding.
  • Any medical or psychiatric condition that may increase the risk associated with study participation or may interfere with the interpretation of study results. Conditions include but are not limited to:
  • Human immunodeficiency virus infection or acquired immunodeficiency syndrome-related illness.
  • Active or uncontrolled clinically serious infection. (Participants with chronic viral hepatitis are eligible.)
  • Ongoing or recent history of drug abuse.
  • Uncontrolled hereditary or acquired thrombotic or bleeding disorder.
  • Bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection.
  • Therapeutic dose anticoagulation with warfarin, low molecular-weight heparin, or similar agents.
  • Chronic therapy with nonsteroidal anti-inflammatory agents or other anti-platelet agents. Aspirin at doses up to 100 milligrams/day is permitted.
  • The participant received prior immunotherapy and is experiencing or has experienced any of the following (OLE cohort only):
  • Any clinically significant Grade 3 immune-related adverse event (irAE)
  • Any grade neurologic or ocular irAE
  • Any grade immune-related pneumonitis, cardiomyopathy, or hepatitis
  • The participant received prior immunotherapy and at the time of study enrollment, requires steroids or other immunosuppressive agents (OLE cohort only).

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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