A Study of the Effectiveness and Safety of AMG 386 and Sorafenib to Treat Advanced or Inoperable Hepatocellular Cancer

Phase 2CompletedNCT00872014

Amgen60 enrolled

Overview

The purpose of this study is to determine whether AMG 386, in combination with Sorafenib, is effective in the treatment of advanced or inoperable Hepatocellular cancer in subjects who have not received any prior systemic therapy except surgery or locoregional therapy. Disease status and disease progression will be assessed every 8 weeks. Subjects will remain on treatment until: progressive disease by RECIST criteria; clinical progression; death or loss to follow-up; or withdrawal of informed consent.

The primary objective is to evaluate the efficacy of AMG 386 in combination with sorafenib as measured by the progression free survival (PFS) rate at 4 months in subjects with advanced or inoperable hepatocellular carcinoma (HCC).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Advanced Hepatocellular Carcinoma Inoperable Hepatocellular Carcinoma

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Histologically confirmed advanced or inoperable HCC * Child-Pugh A liver function score * Measurable disease with at least one unidimensionally measurable lesion per RECIST 1.0 guidelines with modifications * Adequate organ and hematological function * Men or women greater than or equal to 18 years old * Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less Exclusion Criteria: * Subject is eligible for a liver transplant per investigators discretion * Any previous systemic chemotherapy for HCC * History of arterial or venous thromboembolism within 12 months prior to enrollment * History of clinically significant bleeding within 6 months prior to enrollment * History of central nervous system metastases * Clinically significant cardiovascular disease within 12 months * Uncontrolled hypertension * Subjects with a history of prior malignancy

Outcomes

Primary Outcomes

Progression free survival (PFS) rate at 4 months

Time frame: 4 months

Secondary Outcomes

Incidence of adverse events and significant laboratory abnormalities

Time frame: Adverse events at every visit, significant laboratory abnormalities at least every 4 weeks

Objective response rate, Disease control rate, Progression free survival, Overall survival, Time to progression

Time frame: Radiologic imaging every 8 weeks

Pharmacokinetic parameters for AMG 386 when used in combination with Sorafenib

Time frame: Weeks 1, 2, 5, 9, and every 16 weeks thereafter

Pharmacokinetic parameter for Sorafenib when used in combination with AMG 386

Time frame: Weeks 2, 5, 9, and every 16 weeks thereafter

Incidence of the occurrence of anti-AMG 386 antibody formation

Time frame: Weeks 1, 5, 9, and every 16 weeks thereafter

Baseline values of and changes from baseline in pharmacodynamic, immunologic, biochemical, transcriptional, pharmacogenetic and angiogenic markers

Time frame: Weeks 1, 2, 5, and every 16 weeks thereafter