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

Lilly

Status and phase: Completed; Phase 2

Conditions: Hepatocellular Carcinoma

Treatments: Drug: Sorafenib; Biological: IMC-A12 (cixutumumab) - 20 mg/kg; Biological: IMC-A12 (cixutumumab) - 10 milligrams/kilogram (mg/kg)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00906373

I5A-IE-JAEG (Other Identifier)

CP13-0812 (Other Identifier)

13931

Details and patient eligibility

About

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

Full 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-A12 administered every three weeks in combination with oral sorafenib administered twice daily.

Enrollment: 47 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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47 participants in 2 patient groups

Cohort 1, IMC A12 - 10 mg/kg

Active Comparator group

Description:

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.

Treatment:

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

Drug: Sorafenib

Cohort 2, IMC A12 20 - mg/kg

Active Comparator group

Description:

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

Treatment:

Biological: IMC-A12 (cixutumumab) - 20 mg/kg

Drug: Sorafenib