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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


Phase 2
18 Years
N/A
Not Enrolling
Both
GIST

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Changes in FDG-PET imaging

Outcome Time Frame:

28 days

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

120GS201

NCT ID:

NCT00618319

Start Date:

February 2008

Completion Date:

April 2010

Related Keywords:

  • GIST
  • Gastrointestinal Stromal Tumors

Name

Location

Research SiteAlexandria, Minnesota  
Research SiteAlbany, New York  
Research SiteChattanooga, Tennessee