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

March 7, 2016 updated by: Amgen

Phase 2 Open-label Multi-Center Study to Evaluate the Efficacy and Safety of AMG 386 and Sorafenib as First Line Therapy for Subjects With Advanced or Inoperable Hepatocellular Carcinoma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Actual)

60

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 15mg/ kg cohort
AMG 386 15mg/kg intravenously once weekly and Sorafenib 400mg orally twice daily in an every 4 weeks dosing schedule.
Drug: AMG 386
Two doses of AMG 386 (15 mg/kg) IV QW will be studied
Drug: AMG 386
Two doses of AMG 386 (10 mg/kg) IV QW will be studied
Drug: Sorafenib
Sorafenib 400 mg PO BID orally twice daily in an every 4 week dosing schedule for 15mg/kg cohort & 10mg/kg cohort
Experimental: 10 mg/kg cohort
AMG 386 10mg/kg intravenously once weekly and Sorafenib 400mg orally twice daily in an every 4 weeks dosing schedule.
Drug: AMG 386
Two doses of AMG 386 (15 mg/kg) IV QW will be studied
Drug: AMG 386
Two doses of AMG 386 (10 mg/kg) IV QW will be studied
Drug: Sorafenib
Sorafenib 400 mg PO BID orally twice daily in an every 4 week dosing schedule for 15mg/kg cohort & 10mg/kg cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression free survival (PFS) rate at 4 months
Time Frame: 4 months
4 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of adverse events and significant laboratory abnormalities
Time Frame: Adverse events at every visit, significant laboratory abnormalities at least every 4 weeks
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
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
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
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
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
Weeks 1, 2, 5, and every 16 weeks thereafter

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

March 12, 2009

First Submitted That Met QC Criteria

March 26, 2009

First Posted (Estimate)

March 30, 2009

Study Record Updates

Last Update Posted (Estimate)

April 4, 2016

Last Update Submitted That Met QC Criteria

March 7, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20080580

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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