Sorafenib With BIIB022 in Hepatocellular Carcinoma (HCC)

Brief Summary

Official Title: “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 Type: Interventional
  • Study Design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
  • Study Primary Completion Date: April 2011

Interventions Used in this Clinical Trial

  • Drug: BIIB022
    • IV Q3W
  • Drug: Sorafenib
    • Standard dosing of Sorafenib

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: Sorafenib Monotherapy
    • Sorafenib Monotherapy
  • Experimental: Sorafenib with BIIB022
    • Sorafenib with BIIB022

Outcome Measures for this Clinical Trial

Primary Measures

  • 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
      Safety Issue?: No

Secondary Measures

  • To evaluate the PK profile of BIIB022 and sorafenib in this study population
    • Time Frame: 6 months
      Safety Issue?: No
  • To assess the anti-tumor response in this study population
    • Time Frame: 6 months
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • Biogen
  • Provider of Information About this Clinical Study
    • Terri Senta-McMillian, PRA, Int’l


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