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 |
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.
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.
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
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