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


Phase 1
18 Years
N/A
Not Enrolling
Both
Hepatocellular Carcinoma

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To evaluate the safety and tolerability of BIIB022 given once every 3 weeks in combination with sorafenib in subjects with advanced HCC.

Outcome Time Frame:

6 months

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

212HC201

NCT ID:

NCT00956436

Start Date:

August 2009

Completion Date:

April 2011

Related Keywords:

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

Name

Location

Resesarch SiteDenver, Colorado  
Resesarch SiteOcoee, Florida  
Resesarch SiteIndianapolis, Indiana  
Resesarch SiteBoston, Massachusetts  
Resesarch SiteNew York, New York  
Resesarch SiteNorfolk, Virginia