Gastrointestinal Stromal Tumor Studies
   
  120-GS-201
Gastrointestinal Stromal Tumors
   
   
 
 
 
 
 
 
 
 
 
 

 


120-GS-201, Gastrointestinal Stromal Tumors

An Open-Label, 18FDG-PET Pharmacodynamic Assessment of the Effect of BIIB021 in Subjects With Gastrointestinal Stromal Tumors (GIST)

This study is closed to enrollment.

Purpose

This study will examine the effect of BIIB021 on GIST growth and metabolism.


Study Design:  Treatment, Open Label, Uncontrolled, Single Group Assignment
 
Official Title: An Open-Label, 18FDG-PET Pharmacodynamic Assessment of the Effect of BIIB021 in Subjects with Gastrointestinal Stromal Tumors (GIST) Refractory to, Intolerant of, or Not a Candidate for Imatinib and Sunitinib Treatment


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • Changes in FDG-PET imaging 
Secondary Outcome Measures:
  • Characterize the safety profile of BIIB021 
 
Estimated Enrollment:   25
Study Start Date:   February 2008
Estimated Primary Completion Date:  

October 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental BIIB021
Drug: BIIB021
Dose, schedule, and duration specified in protocol


Eligibility

Ages Eligible for Study:  

18 Years and older

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
  2. Age greater than or equal to 18 years at the time of informed consent.
  3. Pathologically confirmed GIST refractory to, intolerant of, or not a candidate for imatinib and sunitinib therapy.
  4. FDG PET standard uptake value (SUVmax; averaged over a maximum of 5 lesions) greater than or equal to 2 at screening.
  5. ECOG performance status of less than or equal to 2.
  6. Lab values consistent with adequate renal hepatic and bone marrow function.
  7. Must utilize effective contraception.

Exclusion Criteria:

  1. Prior treatment with imatinib, sunitinib, or sorafenib with in 14 days of day 1.
  2. Prior treatment with Hsp90 inhibitors at any time.
  3. Prior antitumor therapies including prior experimental agents, approved antitumor small molecules (excluding imatinib, sunitinib, or sorafenib) and biologics, or radiotherapy with in 28 days or <3 half lives (whichever is longer) before start of BIIB021treatment.
  4. Diabetes treated with insulin and/ or concurrent severe or uncontrolled other medical disease (i.e, systemic infection, hypertension, coronary artery disease, congestive heart failure).
  5. History of/ or predisposition to seizures.

Please refer to: www.biogenideconcology.com

Please refer to the clinicaltrials.gov website for further details on the study: http://clinicaltrials.gov/ct2/show/NCT00618319

To contact Biogen, click here.

 

 
 
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