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

Completed · Phase 2

Conditions studied: GIST

In brief

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

Key facts

Study ID

NCT00618319

Run by

Biogen

People needed

20

Starts

2008-02-01

Expected to finish

2010-04-01

Last updated by the study team

2015-10-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Reseach Facility — Encinitas, California, United States
• Research Site — Santa Monica, California, United States
• Reseach Facility — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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