A Study of IMC-A12 in Combination With Sorafenib in Participants With Advanced Cancer of the Liver

Completed · Phase 2

Conditions studied: Hepatocellular Carcinoma

In brief

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

Key facts

Study ID

NCT00906373

Run by

Eli Lilly and Company

People needed

47

Starts

2009-05-01

Expected to finish

2014-05-01

Last updated by the study team

2018-06-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• ImClone Investigational Site — Scottsdale, Arizona, United States
• ImClone Investigational Site — Los Angeles, California, United States
• ImClone Investigational Site — Chicago, Illinois, United States
• ImClone Investigational Site — Metairie, Louisiana, United States
• ImClone Investigational Site — Burlington, Massachusetts, United States
• ImClone Investigational Site — New York, New York, United States
• ImClone Investigational Site — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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