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NCT00956436 Clinical Trial

Sorafenib With BIIB022 in Hepatocellular Carcinoma (HCC)

Hepatocellular Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00956436
Other study ID # 212HC201
Secondary ID
Status Completed
Phase Phase 1
First received August 5, 2009
Last updated September 12, 2013
Start date August 2009
Est. completion date April 2011

Study information
Verified date November 2011
Source Biogen
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date April 2011
Est. primary completion date April 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Singapore Resesarch Site Singapore
Taiwan Resesarch Site Tainan
Taiwan Resesarch Site Taipei
Taiwan Resesarch Site Tao-Yuan
United Kingdom Resesarch Site Edgbaston Birmingham
United States Resesarch Site Boston Massachusetts
United States Resesarch Site Denver Colorado
United States Resesarch Site Indianapolis Indiana
United States Resesarch Site New York New York
United States Resesarch Site Norfolk Virginia
United States Resesarch Site Ocoee Florida

Sponsors (1)
Lead Sponsor Collaborator
Biogen

Countries where clinical trial is conducted

United States,  Singapore,  Taiwan,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary To evaluate the safety and tolerability of BIIB022 given once every 3 weeks in combination with sorafenib in subjects with advanced HCC. 6 months No
Secondary To evaluate the PK profile of BIIB022 and sorafenib in this study population 6 months No
Secondary To assess the anti-tumor response in this study population 6 months No
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