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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2014-05-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Hepatocellular Carcinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort 1, IMC A12 - 10 mg/kg

Treatment cycles will repeat until there is evidence of progressive disease (PD), toxicity, or withdrawal. If any participant experiences a dose-limiting toxicity (DLT), an additional 3 participants will be enrolled at this dose level (for a total of 6). If no further DLTs, enrollment into Cohort 2 will occur.

Group Type ACTIVE_COMPARATOR

IMC-A12 (cixutumumab) - 10 milligrams/kilogram (mg/kg)

Intervention Type BIOLOGICAL

intravenous infusions 10 mg/kg on Day 1 of each 3-week cycle

Sorafenib

Intervention Type DRUG

400 milligrams (mg) twice per day orally

Cohort 2, IMC A12 20 - mg/kg

Treatment cycles will repeat until there is evidence of PD, toxicity, or withdrawal.

Group Type ACTIVE_COMPARATOR

IMC-A12 (cixutumumab) - 20 mg/kg

Intervention Type BIOLOGICAL

intravenous infusions 20 mg/kg on Day 1 of each 3-week cycle

Sorafenib

Intervention Type DRUG

400 milligrams (mg) twice per day orally

Interventions

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IMC-A12 (cixutumumab) - 10 milligrams/kilogram (mg/kg)

intravenous infusions 10 mg/kg on Day 1 of each 3-week cycle

Intervention Type BIOLOGICAL

IMC-A12 (cixutumumab) - 20 mg/kg

intravenous infusions 20 mg/kg on Day 1 of each 3-week cycle

Intervention Type BIOLOGICAL

Sorafenib

400 milligrams (mg) twice per day orally

Intervention Type DRUG

Other Intervention Names

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cixutumumab LY3012217 cixutumumab LY3012217

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No