Sorafenib With BIIB022 in Hepatocellular Carcinoma (HCC)

September 12, 2013 updated by: Biogen

A Phase 1b, Open-Label Study of Sorafenib With BIIB022 in Subjects With Advanced Hepatocellular Carcinoma

This is a phase 1b, open-Label study of sorafenib with BIIB022 in subjects with advanced hepatocellular carcinoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore
        • Resesarch Site
  • Taiwan
      • Tainan, Taiwan
        • Resesarch Site
      • Taipei, Taiwan
        • Resesarch Site
      • Tao-Yuan, Taiwan
        • Resesarch Site
  • United Kingdom
    • Birmingham
      • Edgbaston, Birmingham, United Kingdom
        • Resesarch Site
  • United States
    • Colorado
      • Denver, Colorado, United States
        • Resesarch Site
    • Florida
      • Ocoee, Florida, United States
        • Resesarch Site
    • Indiana
      • Indianapolis, Indiana, United States
        • Resesarch Site
    • Massachusetts
      • Boston, Massachusetts, United States
        • Resesarch Site
    • New York
      • New York, New York, United States
        • Resesarch Site
    • Virginia
      • Norfolk, Virginia, United States
        • Resesarch Site

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:

  • Age ≥18 years
  • Histologically-confirmed advanced HCC with at least 1 target lesion measurable by modified RECIST.
  • Child-Pugh score A5 or A6.
  • ECOG Performance Status of ≤2.

Exclusion Criteria:

  • Known central nervous system or brain metastases.
  • Prior anti-IGF-1R therapy.
  • Prior systemic therapy for advanced HCC. Prior local therapies are only permitted if subjects have documented disease progression according to modified RECIST.
  • Concurrent anticancer therapy.
  • History of myocardial infarction within 12 months prior to Day 1 or chronic heart failure.
  • Acute hepatitis
  • Fibrolamellar HCC

Other protocol-defined inclusion/exclusion criteria may apply

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: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sorafenib Monotherapy
Drug: Sorafenib
Standard dosing of Sorafenib
Other Names:
  • Nexavar
  • HCC
  • Monoclonal Antibody
  • IGF-1R
  • Liver Cancer
  • Hepatocellular Carcinoma
  • BIIB022
Experimental: Sorafenib with BIIB022
Drug: BIIB022
IV Q3W
Other Names:
  • Nexavar
  • Sorafenib
  • HCC
  • Monoclonal Antibody
  • IGF-1R
  • Liver Cancer
  • Hepatocellular Carcinoma

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To evaluate the safety and tolerability of BIIB022 given once every 3 weeks in combination with sorafenib in subjects with advanced HCC.
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate the PK profile of BIIB022 and sorafenib in this study population
Time Frame: 6 months
6 months
To assess the anti-tumor response in this study population
Time Frame: 6 months
6 months

Collaborators and Investigators

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

Sponsor

Biogen

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)

April 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

August 5, 2009

First Submitted That Met QC Criteria

August 10, 2009

First Posted (Estimate)

August 11, 2009

Study Record Updates

Last Update Posted (Estimate)

September 16, 2013

Last Update Submitted That Met QC Criteria

September 12, 2013

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 212HC201

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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