Status:
COMPLETED
A Study of IMC-A12 in Combination With Sorafenib in Participants With Advanced Cancer of the Liver
Lead Sponsor:
Eli Lilly and Company
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
To determine if IMC-A12 given in combination with Sorafenib is safe and effective for participants with advanced liver cancer.
Detailed Description
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-A...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT00906373
Start Date
May 1 2009
End Date
May 1 2014
Last Update
June 4 2018
Active Locations (7)
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1
ImClone Investigational Site
Scottsdale, Arizona, United States, 85259
2
ImClone Investigational Site
Los Angeles, California, United States, 90095
3
ImClone Investigational Site
Chicago, Illinois, United States, 60611
4
ImClone Investigational Site
Metairie, Louisiana, United States, 70006