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



Status:Completed
Conditions:Liver Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:6/6/2018
Start Date:May 2009
End Date:May 2014

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A Multicenter, Phase 2 Study Evaluating IMC-A12 in Combination With Sorafenib as First-Line Therapy for Patients With Advanced Hepatocellular Carcinoma (HCC)

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

The purpose of this study is to determine progression-free survival (PFS) in participants
with unresectable hepatocellular carcinoma who have received no prior systemic therapy when
treated with IMC-A12 administered every three weeks in combination with oral sorafenib
administered twice daily.

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
We found this trial at
7
sites
Philadelphia, Pennsylvania 19104
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Philadelphia, PA
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Burlington, Massachusetts 01805
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Burlington, MA
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Chicago, Illinois 60076
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Chicago, IL
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Los Angeles, California 90095
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Los Angeles, CA
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Metairie, Louisiana 70006
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Metairie, LA
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New York, New York 10011
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New York, NY
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Scottsdale, Arizona 85259
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Scottsdale, AZ
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