Liver Cancer Studies
   
   212-HC-201
 Hepatocellular Carcinoma
   
   
 
 
 
 
 
 
 
 
 
 

 


212-HC-201, Hepatocellular Carcinoma

Sorafenib With or Without BIIB022 in Hepatocellular Carcinoma (HCC)

This study is currently recruiting participants.

Purpose
This is a phase 1b/2, open-Label, randomized study of Sorafenib with or without BIIB022 in subjects with advanced hepatocellular carcinoma.


Study Type:  Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title: A Phase 1b/2, Open-Label, Randomized Study of Sorafenib With or Without BIIB022 in Subjects With Advanced Hepatocellular Carcinoma


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • Phase 1b: To determine the RP2D 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 ]
  • Phase 2: To compare the time-to-progression (TTP) of BIIB022 in combination with sorafenib with sorafenib monotherapy in subjects with advanced HCC. [ Time Frame: 15 months ] [ Designated as safety issue: No ]
 
Estimated Enrollment:   172
Study Start Date:   August 2009
Estimated Study Completion Date:   March 2012
Estimated Primary Completion Date:  

January 2012 (Final data collection date for primary outcome measure)

 

Arms Assigned Interventions

Sorafenib Monotherapy: Experimental
Sorafenib Monotherapy

Drug: Sorafenib
Standard dosing of Sorafenib
Sorafenib with BIIB022: Experimental
Sorafenib with BIIB022
Drug: BIIB022
IV Q3W


Eligibility

Ages Eligible for Study:  

18 Years and older

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  1. Age ≥18 years
  2. Histologically-confirmed advanced HCC with at least 1 target lesion measurable by modified RECIST.
  3. Child-Pugh score A5 or A6.
  4. ECOG Performance Status of ≤2.

 

Exclusion Criteria:

  1. Known central nervous system or brain metastases.
  2. Prior anti-IGF-1R therapy.
  3. Prior systemic therapy for advanced HCC. Prior local therapies are only permitted if subjects have documented disease progression according to modified RECIST.
  4. Concurrent anticancer therapy.
  5. History of myocardial infarction within 12 months prior to Day 1 or chronic heart failure.
  6. Acute hepatitis
  7. Fibrolamellar HCC

Other protocol-defined inclusion/exclusion criteria may apply

Please refer to: www.biogenideconcology.com

Please refer to the clinicaltrials.gov website for further details on the study: http://www.clinicaltrial.gov/ct2/show/NCT00956436

To contact Biogen, click here.

 

 

 
 
  
 
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