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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2015-06-30

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Advanced Hepatocellular Carcinoma Inoperable Hepatocellular Carcinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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15mg/ kg cohort

AMG 386 15mg/kg intravenously once weekly and Sorafenib 400mg orally twice daily in an every 4 weeks dosing schedule.

Group Type EXPERIMENTAL

AMG 386

Intervention Type DRUG

Two doses of AMG 386 (15 mg/kg) IV QW will be studied

Sorafenib

Intervention Type DRUG

Sorafenib 400 mg PO BID orally twice daily in an every 4 week dosing schedule for 15mg/kg cohort \& 10mg/kg cohort

10 mg/kg cohort

AMG 386 10mg/kg intravenously once weekly and Sorafenib 400mg orally twice daily in an every 4 weeks dosing schedule.

Group Type EXPERIMENTAL

AMG 386

Intervention Type DRUG

Two doses of AMG 386 (10 mg/kg) IV QW will be studied

Sorafenib

Intervention Type DRUG

Sorafenib 400 mg PO BID orally twice daily in an every 4 week dosing schedule for 15mg/kg cohort \& 10mg/kg cohort

Interventions

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AMG 386

Two doses of AMG 386 (15 mg/kg) IV QW will be studied

Intervention Type DRUG

AMG 386

Two doses of AMG 386 (10 mg/kg) IV QW will be studied

Intervention Type DRUG

Sorafenib

Sorafenib 400 mg PO BID orally twice daily in an every 4 week dosing schedule for 15mg/kg cohort \& 10mg/kg cohort

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No