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

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

Gastrointestinal Stromal Tumor

Completed

2

Start Date 02/01/2008

Age of Trial (yrs) 16.2

Gleevec-resistant

HSP90 inhibitor

Destroy KIT

Specifically GIST and only GIST

120GS201

Biogen Idec

Biogen Idec oncologyclinicaltrials@biogenidec.com

Oral

12/11/2008 Exclusion criteria expanded to limit use of of proton pump inhibitors and metabolic competitors of CYP2C19.

This study will examine the effect of BIIB021, an Hsp90 inhibitor, on GIST growth and metabolism.

Further study details as provided by Biogen Idec:

Primary Outcome Measures:

* Changes in FDG-PET imaging [ Time Frame: 28 days ] [ Designated as safety issue: No ]


Secondary Outcome Measures:

* Characterize the safety profile of BIIB021 [ Time Frame: Duration of study ] [ Designated as safety issue: No ]


Estimated Enrollment: 60
Study Start Date: February 2008
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)