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A Pharmacodynamic Assessment of the Effect of BIIB021 (CNF2024 or CF1983) in Patients with Gastrointestinal Stromal Tumors (GIST) Refractory to, Intolerant of, or Not Candidates for Imatinib and Sunitinib

[Protocol 07-173]

Full Title :
AN OPEN-LABEL, FDG-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
Purpose :

Recurrent gastrointestinal stromal tumor (GIST) is difficult to treat. Standard chemotherapy drugs can cause side effects, and the duration of benefit is usually short. As a result, doctors are seeking new treatments for GIST.

BIIB021 is a new type of targeted chemotherapy that attacks specific proteins (including KIT and the platelet-derived growth factor receptor) in cells. These proteins are important for the growth and development of cancer. BIIB021 works by blocking a third protein called Hsp90. When this protein is blocked by BIIB021, other proteins like KIT and the PDGF receptor are destroyed. Doctors hope that by blocking these proteins, they can cause tumors to shrink.

In this phase II clinical trial, researchers want to determine if BIIB021 can slow the growth of GIST in patients whose disease has spread or returned and for whom imatinib or sunitinib are no longer treatment options. They will assess tumor growth using positron emission tomography (PET) scanning.

BIIB021 is taken orally (by mouth).

Eligibility :

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have a confirmed diagnosis of GIST that has spread or returned.
  • Patients must be refractory to, intolerant of, or not candidates for imatinib or sunitinib therapy.
  • At least 4 weeks must have passed since the completion of prior therapy (2 weeks for prior imatinib, sunitinib, or sorafenib) and entry into the study.
  • Patients must not be confined to a bed or chair for more than half of their normal waking hours.
  • Patients must be age 18 or older.

For more information and to inquire about eligibility for this study, please contact Dr. Gary K. Schwartz at 212-639-8324.

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