Sorafenib With BIIB022 in Hepatocellular Carcinoma (HCC)

This study has been completed.
Sponsor:
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00956436
First received: August 5, 2009
Last updated: September 12, 2013
Last verified: November 2011
  Purpose

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


Condition Intervention Phase
Hepatocellular Carcinoma
Drug: BIIB022
Drug: Sorafenib
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1b, Open-Label Study of Sorafenib With BIIB022 in Subjects With Advanced Hepatocellular Carcinoma

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the PK profile of BIIB022 and sorafenib in this study population [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • To assess the anti-tumor response in this study population [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: August 2009
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sorafenib Monotherapy
Sorafenib Monotherapy
Drug: Sorafenib
Standard dosing of Sorafenib
Other Names:
  • HCC
  • Monoclonal Antibody
  • Hepatocellular Carcinoma
  • Liver Cancer
  • Sorafenib
  • BIIB022
  • IGF-1R
  • Nexavar
Experimental: Sorafenib with BIIB022
Sorafenib with BIIB022
Drug: BIIB022
IV Q3W
Other Names:
  • IGF-1R
  • Liver Cancer
  • Hepatocellular Carcinoma
  • Monoclonal Antibody
  • Sorafenib
  • BIIB022
  • HCC
  • Nexavar

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00956436

Locations
United States, Colorado
Resesarch Site
Denver, Colorado, United States
United States, Florida
Resesarch Site
Ocoee, Florida, United States
United States, Indiana
Resesarch Site
Indianapolis, Indiana, United States
United States, Massachusetts
Resesarch Site
Boston, Massachusetts, United States
United States, New York
Resesarch Site
New York, New York, United States
United States, Virginia
Resesarch Site
Norfolk, Virginia, United States
Singapore
Resesarch Site
Singapore, Singapore
Taiwan
Resesarch Site
Tainan, Taiwan
Resesarch Site
Taipei, Taiwan
Resesarch Site
Tao-Yuan, Taiwan
United Kingdom
Resesarch Site
Edgbaston, Birmingham, United Kingdom
Sponsors and Collaborators
Biogen Idec
  More Information

No publications provided

Responsible Party: Terri Senta-McMillian, PRA, Int'l
ClinicalTrials.gov Identifier: NCT00956436     History of Changes
Other Study ID Numbers: 212HC201
Study First Received: August 5, 2009
Last Updated: September 12, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Biogen Idec:
Liver Cancer
Hepatocellular Carcinoma
Sorafenib
HCC
BIIB022
Open-Label
IGF-1R
Nexavar

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Adenocarcinoma
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Liver Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Antibodies
Antibodies, Monoclonal
Sorafenib
Antineoplastic Agents
Enzyme Inhibitors
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014