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Therapeutic Areas: Gastroenterology
Disease Category: Gastrointestinal Diseases and Disorders

Trial Information

120GS201 - A study of BIIB021, an oral HSP90 inhibitor, in patients with GIST refractory to, or intolerant of, imatinib and sunitinib.

This study will examine the effect of BIIB021, an investigational oral HSP90 inhibitor, on FDG-PET imaging in patients with GIST. This study will be used to collect information on dose level and frequency of dosing. It will also evaluate the safety, drug blood levels, and effectiveness of BIIB021.

Please also refer to the following websites:
http://www.clinicaltrials.gov/ct2/show/NCT00618319
http://www.biogenideconcology.com

Inclusion Criteria:

• 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.
• Age greater than or equal to 18 years at the time of informed consent.
• Pathologically confirmed GIST refractory to, intolerant of, or not a candidate for imatinib and sunitinib therapy.
• FDG PET standard uptake value (SUVmax; averaged over a maximum of 5 lesions) greater than or equal to 2 at screening.
• ECOG performance status of less than or equal to 2.
• Lab values consistent with adequate renal hepatic and bone marrow function.
• Must utilize effective contraception.

Exclusion Criteria:

• Prior treatment with imatinib, sunitinib, or sorafenib with in 14 days of day 1.
• Prior treatment with Hsp90 inhibitors at any time.
• 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.
• Diabetes treated with insulin and/ or concurrent severe or uncontrolled other medical disease (i.e, systemic infection, hypertension, coronary artery disease, congestive heart failure).
• History of/ or predisposition to seizures.

Research Site
Located in:
Rochester, MN 55905
EMail: oncologyclinicaltrials@biogenidec.com

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