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Completed

NCT Number: NCT00956436

Sorafenib With BIIB022 in Hepatocellular Carcinoma (HCC)

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

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Insulin-Like Growth Factor I, Resistance To Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Resesarch Site, Singapore

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BIIB022

Drug

IV Q3W

Other names: IGF-1R, Liver Cancer, Hepatocellular Carcinoma, Monoclonal Antibody, Sorafenib, HCC, Nexavar

Sorafenib

Drug

Standard dosing of Sorafenib

Other names: HCC, Monoclonal Antibody, Hepatocellular Carcinoma, Liver Cancer, BIIB022, IGF-1R, Nexavar

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

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Aug 11, 2009
Registry last updated
Sep 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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