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A Study of IMC-A12 in Combination With Sorafenib in Patients With Advanced Cancer of the Liver - NCT00906373-19104(Clinical Trial 546407)



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City:  Philadelphia
State:  
PA
Zip Code: 19104
Conditions: Hepatocellular Carcinoma
Purpose: To determine if IMC-A12 given in combination with Sorafenib is safe and effective for patients with advanced liver cancer.
Study summary: The purpose of this study is to determine progression free survival (PFS) in patients 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.
Criteria: Inclusion Criteria: - The patient has histologically or cytologically confirmed, unresectable HCC. - The patient 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 patient has not received prior systemic therapy for HCC. Patients may have received prior embolization, chemoembolization, intra-arterial chemotherapy infusion, ethanol injection, radiofrequency ablation, or cryosurgery. - The patient has fasting serum glucose < 160 mg/dL or below the ULN and/or hemoglobin A1C < 7%. If baseline nonfasting glucose < 160 mg/dL, fasting glucose measurement is not required. - The patient has the ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: - The patient has brain metastases. - The patient has acute hepatitis. - The patient has poorly controlled diabetes mellitus. Patients 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 patient has congestive heart failure > class II NYHA, unstable angina pectoris, new onset of angina pectoris, myocardial infarction within the past 6 months, or cardiac ventricular arrhythmias requiring antiarrhythmic therapy. - The patient has experienced a hemorrhage or bleeding event ≥ NCI-CTCAE Grade 3 within 4 weeks prior first dose of study therapy.
Study is available at: ImClone Investigational Site
Philadelphia, PA 19104
United States

Primary Contact:
There may be multiple sites in this clinical trial, inquire by e-mail.
Email: ClinicalTrials@imclone.com
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 23, 2011
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