Trial Information

Summary: A Phase I Study of BIIB021 Administered Once or Twice Daily to Subjects with Advanced Solid Tumors

The purpose of this study is to determine the safety and tolerability of BIIB021 when administered to patients with advanced solid tumors. The study will assess the effects of the drug on patients and their cancers by following potential side effects of patients and through pharmacokinetics of BIIB021. Pharmacokinetics (PKs) is a way to determine the level of drug in the patient's blood and to study how the body processes the drug by looking at how the drug is absorbed, distributed, metabolized and eliminated. This is done by frequent blood draws on key days during the first four weeks of treatment.

BIIB021 is an oral, targeted therapy and is an inhibitor of heat shock protein (Hsp90) which acts as a chaperone to proteins that are involved in the proliferation (multiplication and growth) of cancer cells. BIIB021 is not approved by the FDA and is considered investigational in this study.

Patient Inclusion Criteria:

• Advanced solid tumors

Not all eligibility criteria are listed. Additional criteria must be met in order to be eligible.

Patient Exclusion Criteria:

• Prior treatment with Hsp90 drugs
• GI disorders interfering with absorption or swallowing
• Chronic diarrhea
• Adrenal insufficiency

If you would like to learn more about participating in this study, please send an e-mail message using the form below.