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CompletedNCT00956436Updated Sep 16, 2013

Sorafenib With BIIB022 in Hepatocellular Carcinoma (HCC)

A Phase 1 interventional study of BIIB022 and Sorafenib in Hepatocellular Carcinoma, sponsored by Biogen. Completed at 11 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-09-16.

Sponsored by Biogen · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Hepatocellular Carcinoma

Keywords

  • Liver Cancer
  • Hepatocellular Carcinoma
  • Sorafenib
  • HCC
  • BIIB022
  • Open-Label
  • IGF-1R
  • Nexavar
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's enrollment of 40 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Biogen is the lead sponsor of 494 studies on the registry; 22 are open to participants now.

Of its 98 completed or terminated interventional studies of FDA-regulated products, 49 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Sorafenib Monotherapy

    Sorafenib Monotherapy

    Drug: Sorafenib

  • Experimental
    Sorafenib with BIIB022

    Sorafenib with BIIB022

    Drug: BIIB022

Interventions

  • DrugBIIB022

    IV Q3W

    Also known as: IGF-1R, Liver Cancer, Hepatocellular Carcinoma, Monoclonal Antibody, Sorafenib, HCC, Nexavar

  • DrugSorafenib

    Standard dosing of Sorafenib

    Also known as: HCC, Monoclonal Antibody, Hepatocellular Carcinoma, Liver Cancer, BIIB022, IGF-1R, Nexavar

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. To evaluate the PK profile of BIIB022 and sorafenib in this study population

    Time frame: 6 months

  2. To assess the anti-tumor response in this study population

    Time frame: 6 months

07

Study locations

11 sites
  • Resesarch Site
    Denver, Colorado, United States
  • Resesarch Site
    Ocoee, Florida, United States
  • Resesarch Site
    Indianapolis, Indiana, United States
  • Resesarch Site
    Boston, Massachusetts, United States
  • Resesarch Site
    New York, New York, United States
  • Resesarch Site
    Norfolk, Virginia, United States
  • Resesarch Site
    Singapore, Singapore
  • Resesarch Site
    Tainan, Taiwan
  • Resesarch Site
    Taipei, Taiwan
  • Resesarch Site
    Tao-Yuan, Taiwan
  • Resesarch Site
    Edgbaston, Birmingham, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00956436
Lead sponsor
Biogen
First posted
Aug 11, 2009
Start date
Aug 2009
Primary completion
Apr 2011
Completion
Apr 2011
Last update
Sep 16, 2013

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2011. You cannot join it, but the record below documents what was studied.

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