Administration of BIIB028 to Subjects With Solid Tumors

• Status: Completed
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Safety and Tolerability of BIIB028

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biogen

Criteria

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.

• Subjects with histological or cytological confirmed solid tumors who have failed standard therapies or for which no standard therapy is available.

• Anticipated survival of at least 3 months in the opinion of the Investigator.

• 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:

• Pregnant (positive pregnancy test) or nursing women

• Prior treatment with Hsp90 inhibitors at any time.

• Prior antitumor therapies including prior experimental agents, approved antitumor small molecules and biologics, or radiotherapy with in 28 days or <3 half lives (whichever is longer). In addition,prior to enrollment, all asociated toxicities must have been resolved to eligibility levels.

• Concurrent severe or uncontrolled other medical disease (i.e, diabetes, hypertension, coronary artery disease, congestive heart failure), which in the opinion of the Investigator and/ or the Sponsor could compromise assessment of safety.

• Use of anticoagulants, except low dose warfarin.

• History of seizure, previous significant head trauma (e.g., associated with loss of consciousness for more than 5 minutes), abrupt discontinuation of benzodiazepines, or use of potentially epileptogenic medication